Reported trial results for Schizophrenia

Every Schizophrenia trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.

194 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

NCT01945333 · results posted 17 July 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT01945333) enrolled 115 people in total across four groups. Participants were divided based on two things: which type of computer-based brain programme they were assigned to ("Brain Basics" or "Brain Training"), and whether they had difficulty matching tones — a measure of a particular auditory skill — before the trial started ("Impaired" or "Intact" tone matchers). The trial was primarily testing whether it was practical to enrol people, randomly assign them to a group, and keep them engaged through to the end — in other words, it was checking whether this kind of study could actually be run, rather than drawing firm conclusions about the programmes themselves. Secondary measures looked at changes in thinking and memory skills (called neurocognition) at the end of 10 weeks of treatment and again at a 3-month follow-up. The reported data shows that, for the primary measure of feasibility, between 17 and 22 out of the 23–32 people who started in each group went on to complete their allocated programme. For the secondary measure of thinking and memory skills — rated on a standardised scale where the average score in the general population is 50 — all four groups showed some increase in their scores between the start and the end of treatment. The reported changes at 10 weeks ranged from 3.9 to 6.1 points across the groups (higher change means a higher score than at the start). At the 3-month follow-up, the reported changes ranged from 4.4 to 7.6 points across the groups. The data for the symptom severity measure (SCI-PANSS) was not reported in the submitted results. Additional pre-specified measures were also reported. The reported data shows changes in tone-matching ability (scored out of 100%) ranged from 0.20 to 3.82 percentage points across groups at 10 weeks, and changes in a daily living skills assessment (scored out of 100) ranged from 6.5 to 12.1 points across groups at 10 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04092686 · results posted 18 June 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT04092686) enrolled 464 participants across three groups: one group received a placebo (a dummy treatment with no active ingredient), one received a 75 mg dose of SEP-363856, and one received a 100 mg dose of SEP-363856. The trial ran for 6 weeks and was primarily measuring changes in schizophrenia symptom severity using two standardised rating tools completed by clinicians — the PANSS (a 30-question interview covering a range of symptoms) and the CGI-S (a single question rating overall illness severity). Around 365 of the 464 participants completed the trial. The reported data shows that on the main measure — the PANSS total score, where a lower score means fewer or less severe symptoms — all three groups showed a reduction (improvement) from their starting scores over the 6 weeks. The placebo group's score fell by an average of 14.3 points, the 75 mg group's score fell by an average of 16.4 points, and the 100 mg group's score fell by an average of 18.1 points. On the secondary measure — the CGI-S severity rating — the reported data shows average reductions of 0.78 points for the placebo group, 0.91 points for the 75 mg group, and 0.93 points for the 100 mg group. These figures represent the average changes observed within each group as reported to ClinicalTrials.gov. No other outcome data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05211947 · results posted 8 April 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,356 people, all of whom received a drug called iclepertin at a dose of 10 mg. Of those who started, 632 people completed the trial and 724 did not finish. The trial's main focus was on tracking unwanted health events (called "treatment emergent adverse events") that occurred while people were taking the medication. It also looked at two secondary measures: changes in the severity of participants' condition using a rated scale, and changes in haemoglobin levels (a measure of red blood cells in the blood). The reported data shows that 838 out of 1,356 participants experienced at least one treatment emergent adverse event during the trial. For the condition severity scale (rated 1 to 4, where lower numbers mean less severe), the reported data shows an average change of −0.13 points from the start of the trial to the end — meaning scores shifted only very slightly on that scale. For haemoglobin levels, the reported data shows an average change of +0.2 grams per litre from the start of the trial to the end of treatment. These figures describe what was measured and recorded during the trial, and no conclusions about whether iclepertin is beneficial or harmful can be drawn from these numbers alone. Any numbers not listed above were not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05899348 · results posted 18 March 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in a single group called "iTEST," of whom 52 completed the study and 8 did not finish. The trial was measuring a concept called **introspective accuracy** — that is, how well people could judge their own performance on memory and thinking tasks. Specifically, participants each day estimated how many items they got right on two tasks (recognising emotions in photos of faces, and remembering a list of words), and the difference between their guess and their actual score was recorded. The trial also tracked how consistently participants engaged with the daily mobile phone prompts over 16 weeks. The reported data shows that for the main daily training tasks, participants had an average introspective accuracy score of 3.70 at one time point and -0.77 at another (on a scale of 0–10, where a score closer to zero reflects a smaller gap between estimated and actual performance). For a separate card-sorting thinking task used as an additional check, the reported scores were 17.30 and 14.66 (on a scale where a score closer to zero again reflects a smaller gap). Regarding engagement, the reported data shows participants completed an average of 87.02% of the daily mobile prompts they were offered across the 16 weeks. For the secondary outcome, a carer-rated scale measuring how well participants managed everyday activities such as work, self-care, and social life (scored 1–5, with higher meaning better) showed reported average scores of 4.11 at one time point and 4.25 at another. It is worth noting the data as submitted did not clearly label which scores correspond to which time points (for example, start versus end of the study), so those pairings cannot be confirmed from the available information. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05380583 · results posted 27 February 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT05380583) involved family members or carers of people experiencing early psychosis. There were four groups tracked: 21 carers who received a program called CRAFT-EP alongside usual treatment, 22 carers who received usual treatment only, and two smaller subgroups made up of the family members' loved ones who had psychosis (4 in the CRAFT-EP group and 18 in the usual treatment group). The trial was measuring how carers' depression, anxiety, and relationship happiness changed over time. The reported data shows the following score changes across the two main carer groups. For depression (measured on a scale of 0–63, where higher means more severe symptoms), the CRAFT-EP group started at around 14.2, dropped to 9.8 mid-way, and reached 6.5 at the end; the usual treatment group started at 10.8, rose slightly to 11.7 mid-way, then came down to 8.6 at the end. For anxiety (measured on a scale of 20–80, where higher means more severe symptoms), the CRAFT-EP group went from 45.3 down to 38.7 and then to 32.8; the usual treatment group went from 41.8 up to 45.2 and then to 42.4 at the end. For relationship happiness (measured on a scale of 1–10, where higher means greater happiness), the CRAFT-EP group started at 3.7, rose to 5.4, and reached 6.1 by the end; the usual treatment group started at 4.2, dipped to 4.0, and ended at 5.0. These numbers describe what was recorded in the study — the reported data does not tell us why the scores changed or whether the differences between groups are meaningful beyond what was observed in this small group of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04013555 · results posted 11 February 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT04013555) tested a supplement called N-acetylcysteine (NAC) compared to a placebo (an inactive dummy treatment) in people who also received tryptophan (an amino acid). The trial used a "crossover" design, meaning participants received both the NAC and the placebo at different times. Around 36–70 people started the trial across two challenge days, with roughly 51–58 completing both sessions. The trial was measuring levels of certain chemicals in the blood — kynurenine and kynurenic acid (both natural substances produced when the body breaks down tryptophan) — as well as blood flow in the brain, to see whether NAC had any effect on these measures compared to placebo. The reported data shows that blood levels of kynurenine (measured in very small units called pmoles per microlitre) were reported as 2.39 for the NAC group and 1.97 for the placebo group at one time point, rising to 22.0 versus 23.3, and then 65.8 versus 94.0 at later time points. For kynurenic acid (measured in even smaller units called fmoles per microlitre), the reported figures were 48.1 versus 42.9, then 1,687 versus 1,322, and then 5,758 versus 7,471 across the same time points. For whole-brain grey matter blood flow (how much blood moves through the brain's grey matter, measured in millilitres per 100 grams of brain tissue per minute), the reported data shows 49.9 for the NAC group versus 52.5 for the placebo group at one point, and 54.4 versus 57.3 at another. The data as submitted does not include information about whether these differences between groups were considered meaningful by the researchers, nor are full statistical details reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03238326 · results posted 4 February 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT03238326) involved participants who were already taking part in an earlier study of brexpiprazole (a medication used for psychiatric conditions). The trial had two parts: a short four-week "conversion period," in which 14 new ("de novo") participants joined, and a longer open-label period of about 25 months, in which participants were divided into groups based on what they had previously received — those who had been on brexpiprazole, those who had been on aripiprazole, those who had been on placebo, and the new de novo group (20 people). Across these groups, between 295 and 299 people entered the open-label period in total. The trial was primarily measuring how many participants experienced adverse events (unexpected medical occurrences that may or may not be related to the study medication), serious adverse events, and discontinuations due to adverse events. It also tracked changes in certain blood test results over time. The reported data shows that during the four-week conversion period, 5 of the 14 de novo participants experienced at least one adverse event, and none experienced a serious adverse event or left the trial because of one. During the longer open-label period, the number of participants who experienced at least one adverse event was 58 out of 99 in the group that had previously been on brexpiprazole, 54 out of 89 in the group that had previously been on aripiprazole, 63 out of 87 in the group that had previously been on placebo, and 13 out of 20 in the de novo group. Serious adverse events during the open-label period were reported in 4, 1, 3, and 1 participants in those same groups respectively. The number who left the trial because of an adverse event was 4, 2, 3, and 0 in those groups. The reported data also shows that changes in blood test results — including liver-related enzymes, blood sugar markers, cholesterol, and other chemistry measures — were generally small across all groups over the course of the open-label period, though the exact figures varied between groups and between individual measurements. The specific numbers for each blood test across each group are listed in the trial's data submission, and no group showed a large uniform shift in any single measure. Where individual sub-measures are concerned, the data was reported as average changes from the starting point, and those changes were modest in most cases. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03383874 · results posted 19 December 2025

According to the results reported on ClinicalTrials.gov, this trial involved 67 people in total — 36 were given a placebo (a dummy treatment with no active ingredient) and 31 were given a probiotic supplement called Probio-Tec BG-VCap-6.5. The trial was looking at whether taking a probiotic could affect the rate of psychiatric relapse, meaning whether participants needed to be re-admitted to hospital for psychiatric symptoms after having been discharged at least two weeks earlier. Not everyone completed the study — 20 out of 36 people in the placebo group finished, compared to 25 out of 31 in the probiotic group. The reported data shows that the primary outcome measured was the rate of relapse, calculated as the number of re-hospitalisations divided by the number of participants in each group. In the placebo group, this figure was reported as 0.11 re-hospitalisations per participant, and in the probiotic group it was reported as 0.13 re-hospitalisations per participant. No secondary outcome data appears to have been reported in the submitted results. The trial did not report any additional outcome figures beyond these two numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01964404 · results posted 9 December 2025

According to the results reported on ClinicalTrials.gov, this trial involved people across several groups: those with Cannabis Use Disorder (CUD) only, those with schizophrenia only, those with both conditions (called "dual diagnosis" or SCZ-CUD), and healthy volunteers used as a comparison group. In total, 263 people started the pre-randomisation phase across all groups. The trial was measuring how the brain's reward circuitry — particularly a region called the nucleus accumbens — responded during brain scans (fMRI), both at rest and during a money-reward task. Participants in the CUD and SCZ-CUD groups were later randomly assigned to receive either a cannabis cigarette, an oral form of THC called dronabinol (a capsule), or placebos (dummy versions of each), before their second scan. The trial also measured psychiatric symptoms, anxiety ratings, and memory and learning performance. The reported data shows that for the main brain scan measure — a score reflecting the connection strength between two brain reward regions — all groups recorded values close to zero on the scale used (ranging from 0.05 to 0.18 across all groups), with the healthy control group and the schizophrenia-only group both scoring 0.17. The researchers noted that scores similar to healthy controls would be considered a favourable result. For the second primary brain measure (resting-state connectivity), no numerical results were reported in the data submitted. On the symptom scales for schizophrenia-related symptoms (scored 7–49, where higher means more symptoms), the reported data shows positive symptom scores ranging from 9.3 to 11.0 across the SCZ-CUD and schizophrenia-only groups, and negative symptom scores ranging from 15.2 to 17.1. For the verbal learning memory test (scored 0–35, where higher means better), healthy controls recorded the highest average score (31.0), while other groups ranged from 21.8 to 27.9. Anxiety ratings (scored 0–100) ranged from 3.88 to 14.31 across the groups measured, with the schizophrenia-only group recording the highest figure (14.31). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT06061952 · results posted 18 November 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT06061952) looked at a programme called Customised Adherence Enhancement for Schizophrenia (CAE-S) — a structured support intervention aimed at helping people with schizophrenia take their medication as prescribed. The trial enrolled 36 people in total: 19 were assigned to the CAE-S programme and 17 received an enhanced version of their usual care (called eTAU). By the end of the 12-week study, 16 people in the CAE-S group and 13 in the usual-care group had completed it. The reported data shows that, among those in the CAE-S group, participants attended an average of about 4.89 sessions out of those offered over the 12 weeks, and 93.8% of CAE-S participants said they agreed or strongly agreed that the programme was useful. For the secondary measurements, symptom severity was tracked using a standard rating scale (PANSS, scored 30–210, where higher means more severe). The CAE-S group's average score moved from 60.9 at the start to 53.8 at 12 weeks, while the usual-care group's average moved from 66.0 to 54.2. Regarding missed medication doses over the past week (self-reported), the CAE-S group went from 13.4% of days missed at the start to 17.9% at 12 weeks, while the usual-care group went from 13.2% to 8.8%. For missed doses over the past 30 days (self-reported), the CAE-S group went from 11.9% to 7.4%, and the usual-care group from 7.7% to 5.4%. An electronic bottle-cap device also tracked doses: missed doses in the CAE-S group went from 20.8% to 33.8%, compared with 32.1% to 50.0% in the usual-care group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04779177 · results posted 12 November 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 26 adults who each took a 42 mg dose of lumateperone (a tablet) once daily for five days. Twenty-one participants completed the study, and five did not finish. The trial was not testing whether the medicine treated a condition — instead, it was measuring **pharmacokinetics**, which is simply the science of tracking how a drug moves through the body: how quickly it is absorbed, how high its levels rise in the blood, and how long it takes to leave the body. The reported data shows several measurements taken from blood samples. The peak level of lumateperone in the bloodstream (called Cmax) was reported as approximately 19.12 and 23.22 ng/mL (nanograms per millilitre — a very small unit of concentration). The time it took to reach that peak level (Tmax) was reported as 1 hour on both measurement occasions. The total amount of the drug the body was exposed to over time — measured in two slightly different ways (AUC0-t and AUC0-tau) — was reported as roughly 43.6–55.0 and 48.2–58.4 h\*ng/mL respectively. The "half-life" (the time it takes for the drug level in the blood to fall by half) was reported as approximately 2.2 to 2.7 hours. The rate at which the body appeared to clear the drug was reported as approximately 947 to 3,062 litres per hour. The reported data shows two sets of values for each measure, which likely reflect measurements taken on different days of the dosing period, though the specific breakdown was not further detailed in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04846868 · results posted 5 November 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04846868) enrolled 620 adults with schizophrenia — 312 received a daily 10 mg dose of an investigational medicine called iclepertin, and 308 received a placebo (a dummy pill with no active ingredient). The trial ran for 26 weeks and was primarily measuring whether iclepertin affected thinking and cognitive (mental processing) abilities compared to the placebo. A smaller sub-group of 48 participants also took part in an eye safety assessment. The reported data shows that the main outcome — a standardised thinking and cognition score called the MCCB — improved slightly in both groups over 26 weeks: the iclepertin group's score changed by approximately +2.3 points and the placebo group's score changed by approximately +2.2 points (on a scale where higher means better cognition). For the key secondary outcomes, a separate interview-based cognitive rating (SCoRS, where lower scores mean less impairment) decreased by about 5.2 points in the iclepertin group and about 5.5 points in the placebo group. A measure of everyday functional capacity (VRFCAT, where lower scores mean better function) changed by about +3.1 in the iclepertin group and +3.7 in the placebo group. A patient-reported experience score and a problem-solving task also showed small changes in both groups, with the numbers being similar between the two groups across all these measures. In the eye safety sub-study, visual field scores — measured on a scale of 0 to 100% — were reported in the range of approximately 94–96% across both groups at various time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05368558 · results posted 20 October 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05368558) studied a medication called cariprazine in people with schizophrenia. The trial ran in several stages: a double-blind period (where neither participants nor doctors knew who received which treatment), a blinded extension period, and follow-up phases. In the main double-blind period, 34 people took part — 16 received a placebo (a dummy treatment with no active ingredient), 5 received cariprazine at 3 mg, and 13 received cariprazine at 6 mg. The trial's main goals were to count how many participants experienced adverse events (unwanted medical occurrences during the trial) and to measure changes in schizophrenia symptom scores using a standard 30-item rating scale called the SCI-PANSS, where a lower score means fewer symptoms. The reported data shows that, for adverse events during the double-blind period, 12 out of 16 people in the placebo group, 2 out of 5 in the cariprazine 3 mg group, and 10 out of 13 in the cariprazine 6 mg group experienced at least one adverse event. For the SCI-PANSS total symptom score (which runs from 30 to 210, with lower being better), the reported average change from the start to week 6 was minus 15.2 points for the placebo group, minus 5.6 points for the cariprazine 3 mg group, and minus 30.2 points for the cariprazine 6 mg group — a negative number means scores went down (i.e., fewer symptoms were recorded) over the six weeks. The reported data also shows changes in several other symptom scores. On a clinician-rated severity scale (CGI-S, scored 1–7), average changes were −0.6 (placebo), −0.4 (3 mg), and −1.3 (6 mg). For positive symptoms on the SCI-PANSS, changes were −4.7, −2.2, and −8.7 respectively; for negative symptoms, −3.5, −0.2, and −8.1; and on a separate negative symptom scale (NSA-16, scored 16–96), changes were −3.2, −2.8, and −14.5. It is worth noting that the numbers of participants in this trial were very small, which limits what can be drawn from these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT06002958 · results posted 18 September 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT06002958) involved two groups of participants: 20 healthcare providers (called "FEP Providers") and 32 clients receiving care for first-episode psychosis (called "FEP Clients") — 52 people in total. All 52 who started the study completed it. The trial was looking at a digital platform called Horyzons, and measured things like how providers and clients experienced using it, as well as changes in feelings of loneliness and sense of social support among clients. The reported data shows that for the provider group, structured survey scores about how easy or supported they felt implementing Horyzons in their clinic ranged roughly from 3.62 to 4.21 out of 5 across different areas (such as their workplace environment, personal readiness, and the process of putting the platform into practice), where higher scores meant more positive perceptions. For the client group, the reported data shows very small changes in loneliness scores (around −0.10 to −0.18 on a scale of 20–80, where lower scores mean less loneliness) and very small changes in social support scores (around −0.005 to +0.155 on a scale of 19–95, where higher scores mean more perceived support). Clients also rated their overall experience with the platform at an average of 41.56 out of a possible 55. Data on changes in use of emergency and social services was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04820309 · results posted 17 September 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 566 people, all of whom received a treatment called KarXT. The trial was an open-label, long-term safety study — meaning there was no comparison group — and its main purpose was to track what unwanted medical events (called adverse events) occurred while people were taking the drug over time. Secondary measures looked at serious adverse events, how many people stopped taking the drug due to adverse events, and changes in schizophrenia symptom scores over 52 weeks. Of the 566 people who started, 277 completed the study and 289 did not complete it. The reported data shows that 466 out of 566 participants experienced at least one treatment-emergent adverse event — meaning a health issue that appeared or got worse after starting the drug. Of those, 41 participants experienced what were classified as serious adverse events (events such as hospitalisation, life-threatening situations, or significant disability). The reported data also shows that 100 participants stopped taking the study drug because of an adverse event. Regarding the symptom score measurements, the reported data shows changes from the start of the study to week 52 on a scale called the PANSS, which rates the severity of schizophrenia symptoms (higher numbers mean more severe symptoms, with a total possible range of 30 to 210). The total PANSS score changed by an average of minus 5.5 points, the positive symptoms sub-score (covering things like hallucinations and delusions) changed by an average of minus 1.9 points, and the negative symptoms sub-score (covering loss of normal functions) changed by an average of minus 0.8 points. These are average changes across participants; what these numbers mean clinically was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03481049 · results posted 11 August 2025

According to the results reported on ClinicalTrials.gov, this trial looked at three different approaches to a type of incentive-based support program called Contingency Management (CM) — where people receive rewards for meeting certain goals — aimed at reducing alcohol use in people with serious mental health conditions. A total of 158 people were randomly assigned to one of three groups: a "Usual CM" group (53 people), a "High-Magnitude CM" group (54 people), and a "Shaping CM" group (51 people). An additional 234 people were enrolled but not randomly assigned to a group. Of those who were randomised, 41, 35, and 37 people respectively completed the study. The main thing the trial measured was alcohol use, checked through urine tests between weeks 5 and 16 of the program. The test detected a substance called ethyl glucuronide (EtG), which the body produces after drinking alcohol — a negative result (below a set level) indicated no recent drinking. The reported data shows that, on average, the proportion of urine tests coming back negative for recent alcohol use was 0.66 (about 66%) in the Usual CM group, 0.65 (about 65%) in the High-Magnitude CM group, and 0.61 (about 61%) in the Shaping CM group. The trial also planned to measure a range of other things, including mental health symptoms, use of other drugs, cigarette use, and severity of addiction, but the reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of these secondary measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00373672 · results posted 5 August 2025

According to the results reported on ClinicalTrials.gov, this trial involved 58 people in total, split evenly into two groups of 29. One group received a treatment referred to as "ARM" alongside an antipsychotic drug (APD), while the other group received a placebo ("PLC") alongside an antipsychotic drug. All 58 participants completed the study — none dropped out. The trial was measuring cognition, specifically a type of attention and mental focus tested using something called the AX-Continuous Performance Task (AX-CPT). This test looks at how well a person can hold information in mind over a short delay and use it to make the right response — a skill that can be affected in people with schizophrenia. The reported data shows that cognition was measured using a scoring system called "d-prime," where a higher number generally reflects better performance on this particular task. For the ARM + APD group, two scores appear to have been recorded across the study — 2.7 and 2.3. For the PLC + APD group, the two corresponding scores were 2.5 and 3.2. The trial's data as submitted does not include additional detail (such as which scores were taken at the start versus the end of the study), so a fuller picture of how those numbers changed over time is not available from this data alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03034356 · results posted 14 July 2025

According to the results reported on ClinicalTrials.gov, this trial looked at whether the medication levetiracetam had any effect on brain function in participants compared to a placebo (a dummy treatment with no active ingredient). It used a "crossover" design, meaning each person took both the real medication and the placebo at different times, in a randomised order, with a rest period in between. A total of 41 people enrolled across the two groups at the start. Due to dropouts at various stages, 25 people (11 in one group and 14 in the other) completed the full trial. The reported data shows that the main thing being measured was cognitive (thinking and memory) function, using a standardised test called the RBANS, where a score of 100 represents the average for the general population and higher scores indicate better performance. For participants when they were taking levetiracetam, the average score reported was 73.68. For participants when they were taking the placebo, the average score reported was 74.04. The reported data also includes figures of 3.36 and 3.96 for the two conditions respectively, though the trial record does not clearly label what these additional numbers represent, so their meaning cannot be stated with certainty here. The trial also intended to measure resting brain activity in a memory-related area of the brain (the hippocampus) using a brain scan technique called fMRI, as a secondary outcome. However, the reported data shows that no numerical results were submitted to ClinicalTrials.gov for this measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05643196 · results posted 30 May 2025

According to the results reported on ClinicalTrials.gov, this trial looked at a technique called Pulsed Low-Intensity Focused Ultrasound (PLIFUS) — a non-invasive method that uses sound waves directed at a specific area deep in the brain. Ten people took part in total, split into two groups of five. It was a "crossover" trial, meaning everyone received both the real PLIFUS treatment and a sham (a fake version designed to look and feel the same) at different points in the study. The trial was measuring whether PLIFUS changed activity in a particular brain region (the Globus Pallidus Interna), and also tracking scores on two questionnaires about auditory hallucinations (hearing voices) and delusional thinking. The reported data shows that for the primary outcome — changes in brain activity measured by MRI scans — no numerical results were submitted to ClinicalTrials.gov, so those figures are not available. For the secondary outcomes, the reported data shows that scores on the auditory hallucinations questionnaire (rated 0–44, where higher means more severe) changed by an average of −1.4 points in the PLIFUS group and −1.0 points in the sham group from the start of the study. On the delusions questionnaire (rated 1–28, where higher means more severe), scores changed by an average of −1.0 points in the PLIFUS group and +0.3 points in the sham group — meaning the sham group's average score was slightly higher at the end than at the start. It is worth noting that this was a very small trial with only 10 participants, and the numbers reported are averages across that small group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT06787781 · results posted 27 March 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people, all of whom completed the study with no drop-outs. All 15 participants were in a single group receiving Alpha Lipoic Acid (ALA), a naturally occurring compound. The trial was measuring a range of blood test results — including cholesterol, blood sugar, liver function, kidney function, and heart rhythm — as well as the severity of schizophrenia symptoms using a standardised rating tool called the PANSS scale (a questionnaire that scores symptom severity from 30 to 210, where higher numbers indicate more severe symptoms). The reported data shows the following average figures for the group at the time of measurement. For blood fats and sugar: total cholesterol was 180.60 mg/dl, HDL ("good" cholesterol) was 37.60 mg/dl, LDL ("bad" cholesterol) was 88.80 mg/dl, and triglycerides (another type of blood fat) were 132 mg/dl. A glucose figure was listed among the measures but a separate number for it was not reported in the submitted data. For liver-related blood markers, the reported averages were: ALT 21.80 U/L, AST 17.80 U/L, GGT 15.60 U/L, and CPK 84.20 U/L. Kidney markers averaged 0.88 mg/dl for creatinine and 30.80 mg/dl for urea (azotemia). The heart rhythm measurement (QTc interval) averaged 408.80 milliseconds, and the average body mass index (a measure of body weight relative to height) was 32.84 kg/m². The reported data shows that the average total PANSS symptom score for the group was 74.80, which according to the scale's own guide falls within the range described as "mild to moderate" symptoms. It is important to note that this trial had no comparison group, so these figures represent a single snapshot of measurements from one small group of 15 people, and no before-and-after comparison data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05623228 · results posted 5 March 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05623228) enrolled 35 participants in total, spread across eight therapy groups ranging in size from 2 to 8 people. The trial was measuring several things in people who took part in different therapy programmes: cognitive functions (such as memory and problem-solving), psychiatric symptoms, how well participants were able to carry out everyday activities, and their sense of personal recovery. Most participants completed the study across two follow-up periods, with only a small number — three people in total across both timepoints — not finishing. The reported data shows the following numbers, measured using standard rating scales before and after the therapy periods. For cognitive functioning, scores on a verbal memory test appeared to rise from around 7.71 to 14.00, and scores on a reasoning and problem-solving test appeared to rise from around 12.09 to 19.04 (on these scales, higher numbers indicate a better result). For psychiatric symptoms measured on the PANSS scale (where lower scores indicate fewer symptoms), the reported total score appeared to fall from approximately 113.62 to 70.18. For everyday functioning (where lower scores indicate less difficulty), scores moved from about 33.47 to 30.49. For personal recovery (where higher scores indicate a stronger sense of recovery), scores appeared to rise from roughly 90.62 to 125.56. For the secondary measure of IQ, only a single figure of 86.17 was reported, and a comparison score was not reported in the data. It is important to note that these are group-level averages across all participants combined, and the trial was small. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01569659 · results posted 28 February 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 67 people in total, split into two groups: 34 people received a standard dose of a medication called lurasidone, and 33 received a higher dose of lurasidone. The trial was studying symptoms of schizophrenia, specifically looking at what are called "positive symptoms" — things like hallucinations or unusual beliefs — using a structured rating tool known as the PANSS (Positive and Negative Symptom Scale). On this scale, trained clinicians interview patients and rate 30 different symptoms; higher scores indicate more severe symptoms. By the end of the study, 22 people in each group had completed the trial, while 12 and 11 people respectively did not finish. The reported data shows that the primary outcome measured was the change in positive symptom scores on the PANSS over the course of the trial. The standard dose group had a reported score change of 22.6 units, and the high dose group had a reported score change of 24.2 units on the positive symptoms portion of the scale. The direction of these changes (that is, whether scores went up or down from the starting point) was not specified in the submitted data, and no further breakdown of secondary outcomes was reported in the data provided. It is also worth noting that the data does not include information on secondary outcome measures, so those results are not available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05207982 · results posted 14 January 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05207982) enrolled 10 people in total — 5 classified as "Patients" and 5 classified as "Supporting Persons" (such as a carer or family member). All 10 participants completed the study with no drop-outs. The trial was measuring changes in body weight over time, with measurements taken at the start of the study, each week during the study period, at the end of the study, and at a follow-up point. The reported data shows individual weight changes (measured in pounds) for each participant across the two groups. For the Patients group, the five reported weight changes were: −6 lbs, −5 lbs, +11 lbs, −4 lbs, and 0 lbs. For the Supporting Persons group, the five reported weight changes were: −3 lbs, −4 lbs, +5 lbs, −14 lbs, and −7 lbs. These figures represent how much each individual's weight went up or down over the course of the study — a negative number means a reduction in weight, and a positive number means an increase. No additional outcome measures (such as averages or group totals) were reported in the submitted data. It is worth noting that this was a very small study involving only 10 people, and the reported results varied considerably from person to person within each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05136690 · results posted 29 November 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 13 healthy participants and 25 people with mild-to-moderate schizophrenia (SZ). All 13 healthy participants completed both study periods, while 20 of the 25 SZ participants completed both periods (one left before Period 2 began, and four did not finish Period 2). The trial was measuring brain signals recorded by EEG — specifically how consistently and strongly the brain responds to certain sound patterns — and whether wearing a nicotine patch changed those signals compared to a dummy (placebo) patch. The reported data shows that, at the start of the trial (before any patches were applied), the brain's rhythmic response to 40 Hz sound stimulation — measured as something called Inter-trial Coherence (ITC), which reflects how consistently the brain "locks on" to a repeated sound — was 0.432 in healthy participants and 0.364 in the SZ group. A separate brain signal called Mismatch Negativity (MMN), which reflects how the brain notices unexpected sounds, was measured at −5.207 microvolts in healthy participants and −3.932 microvolts in the SZ group. Other related signal measurements (timing and other peaks) were also recorded and showed small numerical differences between the two groups, as detailed in the full data. The reported data shows that after the nicotine patch, the change in ITC from baseline was 0.054 for healthy participants and 0.040 for the SZ group; after the placebo patch, the change was 0.000 for healthy participants and 0.010 for the SZ group. Blood nicotine levels two hours after patch application were also measured and reported to be broadly similar across both groups during the nicotine patch sessions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04659174 · results posted 28 October 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04659174) enrolled 152 people with schizophrenia across two groups — 68 in Arm A and 84 in Arm B — who all received a medicine called KarXT. The trial ran for up to 52 weeks and was mainly set up to track how many participants experienced adverse events (unwanted medical occurrences that appeared or got worse after starting the study drug). A relatively small number of participants completed the study — 19 in Arm A and 16 in Arm B — with the majority not completing it, though the reasons were not broken down in the data provided here. The reported data shows that, for the primary measure, 36 out of 68 participants in Arm A and 45 out of 84 participants in Arm B experienced at least one treatment-emergent adverse event (that is, an unwanted medical occurrence that began after the first dose). For the secondary measures related to adverse events: 5 participants in Arm A and 3 in Arm B experienced a serious adverse event (defined as one involving hospitalisation, being life-threatening, causing lasting disability, or resulting in death); and 9 participants in Arm A and 7 in Arm B stopped taking the study drug because of an adverse event. The trial also measured changes in schizophrenia symptom scores using a standardised rating tool (the PANSS, scored from 30 to 210, where lower scores mean fewer symptoms). The reported data shows that, from the start of this extension study to week 52, Arm A's total symptom score changed by −9.0 points on average and Arm B's by −23.9 points — meaning both groups' average scores were lower at week 52 than at the start of this phase of the study. Similar reductions were reported for the sub-scores measuring specific symptom types, though no comparison group without the drug was included in this study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04001114 · results posted 26 September 2024

According to the results reported on ClinicalTrials.gov, this trial involved two groups of adult smokers: 18 people who had a diagnosis of schizophrenia and 13 people who did not. Of those who started, 17 and 9 participants respectively completed the study. The trial was measuring how people responded to cigarettes that contained almost no nicotine — specifically looking at how much carbon monoxide (a marker of how much smoke was inhaled) was in their breath, how well they could tell the difference between a regular cigarette and a very-low-nicotine cigarette, how their smoking behaviour changed over a session, and how their mood, cravings, and withdrawal feelings differed depending on which type of cigarette they smoked. The reported data shows that at the end of an eight-hour smoking session using only very-low-nicotine cigarettes, the breath carbon monoxide reading averaged 62.7 parts per million in the schizophrenia group and 43.0 parts per million in the non-schizophrenia group. For the cigarette discrimination task — where participants tried to identify which type of cigarette they were smoking — the schizophrenia group correctly identified the cigarette type about 65.6% of the time on average, compared to about 81.9% for the other group. Regarding smoking behaviour during the session, the reported data shows a small average difference in cigarettes smoked between the first and last two hours: 1.75 cigarettes in the schizophrenia group and 1.50 in the other group, where a smaller difference suggests people kept smoking at a steadier rate throughout the session. The reported data also includes a combined score reflecting changes in mood, cravings, and withdrawal feelings when comparing nicotine cigarettes to very-low-nicotine cigarettes. This score was 0.13 for the schizophrenia group and 0.039 for the non-schizophrenia group (where higher numbers indicate less withdrawal, less craving, and greater mood-related effects from smoking). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03818256 · results posted 19 September 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03818256) enrolled 71 adults in total — 35 received a daily dose of miricorilant (600 mg) and 36 received a placebo (a dummy pill with no active ingredient). The trial was measuring changes in body weight over 12 weeks, as well as tracking unwanted health events that occurred during the study. A smaller number of participants completed the full trial: 27 in the miricorilant group and 28 in the placebo group, with 8 people in each group not finishing. The reported data shows that, after 12 weeks, body weight changed by an average of −0.98 kg in the miricorilant group and −1.08 kg in the placebo group — meaning both groups lost a small, similar amount of weight on average. When looking at who lost at least 5% of their starting body weight, the reported data shows 2 participants in the miricorilant group and 3 in the placebo group reached that level. The trial also measured insulin resistance using a scoring method called HOMA-IR (a calculation based on blood sugar and insulin levels, where a higher number suggests the body is having more difficulty managing blood sugar). The reported change in HOMA-IR scores was 1.080 in the miricorilant group and 0.890 in the placebo group. Regarding unwanted health events during the study, the reported data shows that 16 people in the miricorilant group and 18 in the placebo group experienced at least one such event. One participant in each group experienced a serious unwanted health event. Three participants in the miricorilant group and one in the placebo group left the study early because of an unwanted health event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03995368 · results posted 19 September 2024

According to the results reported on ClinicalTrials.gov, this study enrolled 93 people across three groups: 28 people with schizophrenia, 34 people with a traumatic brain injury (TBI), and 31 healthy volunteers (people without either condition). Not everyone finished — 26, 23, and 26 people respectively completed the study. The trial was measuring how the brain processes sound and visual information using a technique called EEG (a painless test that records electrical activity in the brain), and also looked at thinking and memory skills, social understanding, and how well people were getting on in their community. The reported data shows the following for the two main (primary) brain-activity measures. For the sound-processing test (called Mismatch Negativity, or MMN — a measure of how strongly the brain reacts when it notices an unexpected sound), the recorded values in microvolts (tiny units of electrical activity) grew larger in all three groups as tones were repeated more often, which was the expected pattern. For example, at the longest repetition sequence, the schizophrenia group recorded −1.14 microvolts, the TBI group −3.13, and the healthy group −2.90. For the visual brain-activity test (which measured how the brain's response to a flickering checkerboard pattern changed after prolonged viewing), the reported data shows modest changes from the starting point across all three groups at each of the three follow-up time points measured, with values ranging roughly from 0.2 to 1.2 microvolts depending on the group and time point. For the secondary measures, the reported data shows that on the overall thinking and memory score (where 50 is the average for the general population), the schizophrenia group scored 35.13, the TBI group 45.32, and the healthy group 46.29. On the facial emotion recognition test (out of 56), scores were 42.4, 46.4, and 44.6 respectively. Community integration sub-scores were also reported across home, social, and activity areas for all three groups. The empathic accuracy measure (how well participants could track another person's feelings in a video) was listed as a secondary outcome, but no numerical results were reported for it in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02918370 · results posted 19 September 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT02918370) enrolled 75 people in total — 36 in the aripiprazole group and 39 in the placebo group. A placebo is a dummy treatment with no active ingredient, used for comparison. The trial was measuring changes in alcohol use, specifically looking at the number of drinks people consumed on the days they drank. This was tracked using a tool called the Timeline Followback (TLFB), which asks participants to recall their recent drinking. The key measurement was how much this figure changed between the start of the trial and week 12. The reported data shows that by week 12, both groups had a reduction in the number of drinks consumed per drinking day compared to when they started. In the aripiprazole group, the reported change was a reduction of 0.82 drinks per drinking day, while in the placebo group the reported change was a reduction of 0.71 drinks per drinking day. Of the 75 people who started the trial, 34 in the aripiprazole group and 30 in the placebo group completed it. No additional outcome measures were included in the data submitted to ClinicalTrials.gov, so further details beyond this primary measure were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03669640 · results posted 12 August 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03669640) looked at symptoms of schizophrenia — particularly a group of symptoms called "negative symptoms," which can include things like low motivation, reduced emotional expression, and social withdrawal. The trial was split into two parts: Part A tested the investigational treatment on its own (monotherapy) compared to a placebo (a dummy treatment with no active ingredient), and Part B tested it as an add-on to existing medication at three different doses (45 mg, 150 mg, and 300 mg) compared to a placebo. In total, 131 people started the trial across all six groups, and 111 completed it. The primary thing being measured was a rating scale called the Brief Negative Symptoms Scale (BNSS), which scores symptom severity from 0 (no symptoms) to 78 (most severe) overall, and 0 to 12 for the motivation/apathy section specifically. The reported data shows that at the start of the trial, motivation/apathy subscale scores across all groups ranged from roughly 5.7 to 6.2 out of 12. By week 12, the reported data shows scores had shifted to between approximately 4.1 and 5.5 across the different groups — with some groups showing a larger numerical change than others. The secondary measures — including clinician-rated scales for overall illness severity and symptom change — also showed various numerical shifts across groups from the start to the end of the trial, though some data points for certain groups were not reported in the submitted results. The reported data also shows scores from other rating scales, including the overall illness severity scale (CGI-S, ranging 0–6) and the symptom change scale (CGI-I, ranging 1–7 where lower numbers mean more improvement), as well as a broader symptom scale (PANSS, ranging 15–105). Across these measures, scores at the end of the trial were broadly similar to where they started for most groups, with small numerical differences between the placebo and treatment groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT06372210 · results posted 31 July 2024

According to the results reported on ClinicalTrials.gov, this trial looked at a wearable skin patch called the D-Tect Patch, which is designed to detect when a person has swallowed a tablet containing a tiny ingestible event marker (IEM) — a small sensor embedded in the pill. The trial involved 54 participants split into two groups: 24 people in Cohort 1 who wore the patch and took a placebo (inactive) tablet with an IEM, and 30 people in Cohort 2 who wore the patch and took Abilify MyCite® (an aripiprazole tablet with an IEM already built in). All 54 participants completed the study. The trial was measuring how accurately the patch detected tablet ingestion, and how quickly that detection was communicated to a mobile device. The reported data shows that in Cohort 1, the patch correctly detected tablet ingestion 100% of the time based on the calculation method used. For timing, the reported data shows that in Cohort 1, the patch detected ingestion roughly 53 seconds after swallowing, while in Cohort 2 this figure was around 312 seconds (just over five minutes). Once the patch detected ingestion, the time for that information to appear on a mobile device was reported as 17 seconds in both groups. The total time from swallowing the tablet to the information appearing on the mobile device was reported as approximately 73 seconds for Cohort 1 and 351 seconds (just under six minutes) for Cohort 2. The reported data also shows that the number of participants who experienced adverse events (unexpected health occurrences during the study) was 7 in Cohort 1 and 3 in Cohort 2, with 5 and 3 participants respectively experiencing events considered related to the device. No serious adverse events and no dropouts due to adverse events were reported in either group. These figures describe what was recorded and counted during the trial period only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03198078 · results posted 20 December 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 316 young people across three groups: 110 received brexpiprazole, 102 received aripiprazole, and 104 received a placebo (an inactive treatment used as a comparison). The trial was measuring changes in symptoms of schizophrenia over six weeks, using several rating scales — mainly the PANSS (Positive and Negative Syndrome Scale), where a higher score means more severe symptoms, with the total score ranging from 30 to 210. The reported data shows that for the main outcome — the change in total PANSS score from the start of the trial to week six — all three groups showed a reduction (improvement) in scores. The brexpiprazole group had an average reduction of about 22.8 points, the aripiprazole group about 24.0 points, and the placebo group about 17.4 points. For secondary outcomes, the reported data shows that roughly 44% of participants in both the brexpiprazole and aripiprazole groups met the threshold for "response" (at least a 30% improvement in PANSS score or a low severity rating), compared with about 28% in the placebo group. For "remission" (symptom scores falling below a set level across several specific items), the figures were approximately 29% for brexpiprazole, 36% for aripiprazole, and 23% for placebo. Scores on overall functioning (CGAS) and illness severity (CGI-S) also showed reductions across all three groups, with the two active treatment groups reporting slightly larger changes than the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04659161 · results posted 12 December 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04659161) enrolled 252 people with schizophrenia — 126 in the KarXT group and 126 in the placebo (dummy treatment) group. The trial ran for five weeks and was mainly measuring changes in a standardised rating scale called the PANSS (Positive and Negative Syndrome Scale), which clinicians use to score the severity of schizophrenia symptoms. The total PANSS score can range from 30 to 210, and a lower score indicates fewer or less severe symptoms. By the end of the study, 94 people in the KarXT group and 100 in the placebo group had completed the trial. The reported data shows that, on average, participants in the KarXT group had their PANSS total score fall by 21.2 points from where they started, while participants in the placebo group had an average fall of 11.6 points. For the sub-scores, the KarXT group's "positive symptoms" score (things like hallucinations) dropped by an average of 6.8 points compared to 3.9 points for the placebo group, and the "negative symptoms" score (things like emotional withdrawal) dropped by an average of 3.4 points compared to 1.6 points. A clinician-rated scale of overall illness severity (scored 1–7) also showed an average drop of 1.2 points in the KarXT group versus 0.7 points in the placebo group. Additionally, the reported data shows that 51% of participants in the KarXT group had their total PANSS score reduce by 30% or more, compared with 28% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04030143 · results posted 18 November 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04030143) enrolled 266 adults with schizophrenia or Bipolar I Disorder — 132 in one group receiving a two-monthly injectable form of aripiprazole (960 mg, given every two months) and 134 in a comparison group receiving a monthly injectable form (400 mg, given every month). The trial was primarily measuring a range of safety-related things: how many participants experienced medical events after starting treatment, whether there were any notable changes in vital signs (such as blood pressure and heart rate), heart rhythm readings (ECG), blood and urine test results, and scores on two standard scales that check for certain movement-related side effects sometimes associated with this class of medication. The reported data shows that in the two-monthly group, 94 out of 132 participants experienced at least one medical event after starting treatment, compared with 95 out of 134 in the monthly group. For vital signs, only very small numbers of participants in either group — in most categories, zero to two people — had readings that fell outside the pre-defined ranges of concern. Similarly, for heart rhythm readings, the numbers flagged as potentially notable were generally low across both groups, ranging from zero to 17 participants depending on the specific measurement. For laboratory tests, most categories showed only a handful of participants with flagged results, though one measure (creatine kinase) showed 12 participants in the two-monthly group compared with 1 in the monthly group. On the two movement-symptom rating scales (the SAS and AIMS), the reported changes from the start of the trial to the end were very small in both groups — close to zero in either direction on scales that can range from 0 to 40 and 0 to 28 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03859973 · results posted 18 November 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03859973) enrolled 200 adults with schizophrenia — 99 in the group that received a drug called BI 425809 (10 mg) combined with computerised brain-training exercises, and 101 in the group that received a placebo (dummy pill) also combined with the same brain-training exercises. The trial ran for 12 weeks and was mainly measuring whether participants' thinking and memory abilities changed over that time, using a set of standardised mental tests called the MATRICS Consensus Cognitive Battery (MCCB). By the end of the trial, 79 people in the BI 425809 group and 75 in the placebo group had completed it. The reported data shows that on the main measure — a thinking and memory test score where a higher number means better performance — both groups showed a small increase from their starting scores after 12 weeks. The BI 425809 group's score increased by approximately 1.6 points, while the placebo group's score increased by approximately 2.5 points. On a broader version of the same test (which also included social thinking skills), the BI 425809 group's score rose by about 1.2 points and the placebo group's by about 2.2 points. For a rating scale measuring how thinking difficulties affect everyday life (where a lower score means less difficulty), both groups showed a decrease: roughly minus 2.5 points for the BI 425809 group and minus 3.1 points for the placebo group. A general symptom rating scale also showed small decreases (meaning slight improvement) in both groups. The reported data shows that 39.4% of participants in the BI 425809 group and 56.4% in the placebo group experienced at least one adverse event (an unwanted health experience during the trial), while serious adverse events were reported in 1.0% and 2.0% of participants respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03975400 · results posted 3 November 2023

According to the results reported on ClinicalTrials.gov, this trial looked at whether a search engine advertising campaign could help people reach treatment for psychosis (a condition involving a break from reality, such as hearing or seeing things others don't) more quickly. The study took place across six regions in New York State and tracked participants across four phases — before the campaign started and then as the campaign rolled out to more areas. In total, participant numbers across the three geographic groups ranged from 42 to 84 people at the start, with some variation across later phases as the campaign expanded. The primary thing being measured was the "duration of untreated psychosis" — in plain terms, how many days passed between when someone first experienced symptoms and when they received treatment. The reported data shows that before the campaign, this figure was recorded as a median of 5.32 days, and during the active campaign period it was 5.38 days. For the secondary measure — the number of new referrals to treatment services — the reported data shows an average of 86.29 new referrals per period before the campaign, compared with 32.10 during the active campaign period. It is worth noting that these numbers are presented here exactly as submitted to ClinicalTrials.gov, and the data does not include further explanation of how the referral figures or participant counts changed across phases. Any context about what drove these figures was not reported in the structured results data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03955250 · results posted 2 August 2023

According to the results reported on ClinicalTrials.gov, this trial involved 42 people in total — 19 in the group using the Mobile After-Care Support (MACS) App and 23 in a comparison group using a different mobile app (described as an "attention control," meaning a comparison app used to account for the general effect of using any app). The trial was measuring participant satisfaction with their treatment, as well as three other areas: the severity of psychiatric symptoms, how well participants took their prescribed medication, and their use of unhelpful coping strategies. The reported data shows the following numbers at the end of the study. For the main (primary) measure — satisfaction with treatment, scored on a scale of 8 to 32 where higher means more satisfied — the MACS App group scored 23.7 and the comparison group scored 22.5. For psychiatric symptom severity (scored 18–126, higher meaning more severe symptoms), the MACS App group started at 53.1 and ended at 36.4, while the comparison group started at 49.8 and ended at 33.1. For medication-taking (measured as a percentage of doses taken, where 100% means no missed doses), the MACS App group went from 86.2% to 94.4%, and the comparison group went from 83.8% to 92.0%. For unhelpful coping strategies (scored 1–48, higher meaning greater use of unhelpful strategies), the MACS App group went from 28.6 to 24.8, and the comparison group went from 28.1 to 24.4. Of the 42 people who started, 33 completed the trial (17 in the MACS group and 16 in the comparison group), and the data was not reported in a way that explains what happened to those who did not finish. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04268303 · results posted 18 June 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04268303) involved 380 people in total, split across three groups: one group received a 120 microgram dose, another received a 180 microgram dose, and a third received a placebo (an inactive treatment used for comparison). The trial was measuring changes in agitation levels using a tool called the PEC scale — a score made up of five items (such as hostility, tension, and excitement) that ranges from 5 (no agitation) to 35 (extremely severe agitation). The vast majority of participants — 126, 123, and 123 across the three groups respectively — completed the study. The reported data shows that at the start of the trial, all three groups had very similar average PEC scores of around 17.5–17.6 out of 35. By the end of the study period, the reported average score changes were: minus 8.4 points for the 120 microgram group, minus 10.4 points for the 180 microgram group, and minus 4.7 points for the placebo group — meaning all three groups showed lower agitation scores compared to where they started. The reported data also shows how scores changed at earlier time points: at one early measurement, the changes were minus 1.3, minus 2.0, and minus 1.3; at a middle time point, minus 2.8, minus 3.9, and minus 2.5; and at a later time point, minus 4.4, minus 5.7, and minus 3.1 — for the 120 microgram, 180 microgram, and placebo groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04072575 · results posted 31 May 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04072575) enrolled 178 people with schizophrenia who received a 6-monthly injectable form of a medication called paliperidone palmitate (PP6M), given as either a 700 mg or 1000 mg dose. The trial was measuring how many participants experienced a "relapse" — meaning a serious worsening of their schizophrenia symptoms, such as a hospital admission, an emergency department visit, self-harm, or significant aggressive behaviour — as well as tracking unwanted medical events (called adverse events) that occurred during or after treatment. Of the 178 who started, 154 completed the trial and 24 did not. The reported data shows that 7 out of 178 participants met the definition of relapse during the study period. Separately, 111 out of 178 participants experienced at least one adverse event — that is, an unwanted medical occurrence that happened after starting the medication (noting that this does not necessarily mean the medication caused it). For the secondary measures, the reported data shows very small average changes from the start of the trial to the end: the severity-of-illness rating (scored 1–7, where higher means more severe) changed by an average of 0.0 points; a scale measuring personal and social functioning (scored 1–100, where higher means better functioning) changed by an average of +0.5 points; and a broader symptom scale (scored 30–210, where higher means more severe symptoms) changed by an average of 0.7 points. No further breakdown of these figures was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01844726 · results posted 20 April 2023

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called GLYX-13 compared to a placebo (an inactive dummy treatment) in 44 adults — 22 in each group. The trial was measuring two things: brain activity during a learning task (using a brain scan called an fMRI, which tracks blood flow as a way of gauging brain activity), and how accurately participants could learn to sort numbers into categories over a series of trials. The reported data shows that during the brain scanning task, the GLYX-13 group had an average brain activity change of 0.16%, while the placebo group had an average change of 0.08%. For the category-learning task, where participants had to correctly sort numbers into groups across 64 trials, the reported data shows the GLYX-13 group answered correctly on an average of 72.5% of trials, compared to 75.2% for the placebo group. The trial did not report any further breakdown or additional figures beyond these numbers, so no further detail can be drawn from the available data. It is worth noting that 21 out of 22 participants in each group completed the study, with one person in each group not completing it; the reasons were not reported in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03745820 · results posted 18 April 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03745820) enrolled 195 people in total — 64 in the placebo group, 66 receiving a lower dose of BIIB104 (0.15 mg), and 65 receiving a higher dose (0.5 mg). The trial was designed to measure whether BIIB104, compared to a placebo (a dummy treatment with no active ingredient), had any effect on working memory and other aspects of thinking and daily functioning in people with schizophrenia. Around 155 participants completed the study across the three groups. The reported data shows that the primary outcome — a working memory score measured using a recognised cognitive test battery — changed only slightly from the start of the study to week 12 in all three groups. The placebo group's score changed by 1.17 points, the lower-dose group by 0.91 points, and the higher-dose group by 0.84 points (on a scale where higher scores reflect better functioning). For the secondary outcomes, the reported data shows small changes across all groups in everyday functioning tasks and in a separate cognitive rating scale. On a scale assessing physical coordination, scores remained very low across all groups throughout the study. Regarding unwanted medical events, 28 people in the placebo group, 32 in the lower-dose group, and 28 in the higher-dose group reported at least one adverse event (an unexpected medical occurrence during the study), with 1, 1, and 2 serious adverse events reported respectively. A small number of participants across the groups reported at least one instance of suicidal thoughts or behaviour during the study (3 in the placebo group, 4 in the lower-dose group, and 0 in the higher-dose group). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02535923 · results posted 16 February 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 47 people in total — 26 in a group receiving Cognitive Behavioural Therapy for Insomnia (CBT-I) and 21 in a Health and Wellness comparison group. The trial was measuring sleep difficulties, mental health-related quality of life, and participation in society. Not everyone completed all stages: by the end of the follow-up period, 17 people remained in the CBT-I group and 13 in the Health and Wellness group. The reported data shows that the main outcome measured was insomnia severity, using a questionnaire scored from 0 to 28, where higher numbers mean worse sleep difficulties. At the post-treatment assessment (the primary outcome), the CBT-I group scored an average of 11.6 and the Health and Wellness group scored 15.2. At a later follow-up point (a secondary measure), those scores were 12.4 and 13.0 respectively. The reported data also shows scores on a mental health quality-of-life survey (0–100, higher is better): at post-treatment, the CBT-I group averaged 40.0 and the Health and Wellness group 45.5; at follow-up, those figures were 48.4 and 47.8. For a measure of participation in society (0–100, where 100 means full disability), the CBT-I group scored 39.9 and the Health and Wellness group 34.1 at post-treatment, and 42.9 versus 29.6 at follow-up. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04567524 · results posted 8 February 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04567524) enrolled 32 people in total. They were split into four groups: 12 people received a weekly extended-release capsule called LYN-005 at a 14 mg dose, 12 received LYN-005 at a 28 mg dose, and 8 received a standard daily tablet of risperidone (either 2 mg or 4 mg, four people in each). The trial was primarily measuring how the drug moved through the body — things like peak concentration in the blood and how long it took to get there — as well as counting any unwanted events (called treatment-emergent adverse events, or TEAEs, meaning any health issues that appeared or worsened after taking the study treatment). The reported data shows that when it came to TEAEs, 18 out of 24 people in the combined LYN-005 groups experienced at least one, making up a total of 36 individual events across those participants. In the combined risperidone groups, 2 out of 8 people experienced at least one TEAE, totalling 4 events. Regarding how the drug was absorbed into the blood, the reported data shows that for the LYN-005 14 mg groups, peak blood concentration (the highest level reached) ranged from about 18.6 to 31.0 ng/mL across the three measurement periods, compared to roughly 24.8 to 31.2 ng/mL for the 2 mg risperidone groups. For the higher doses, LYN-005 28 mg peak levels ranged from about 24.6 to 31.2 ng/mL, while 4 mg risperidone ranged from about 46.3 to 54.1 ng/mL. The time it took to reach that peak varied notably — some LYN-005 subgroups reached their peak around 24 hours after dosing, while risperidone tablet groups generally peaked within 1.5 to 4 hours. The reported data also shows that the overall amount of the active substance in the blood over time (measured as area under the concentration curve) was generally lower for LYN-005 groups than for the corresponding risperidone tablet groups at both dose levels. For example, LYN-005 14 mg values ranged from 361 to 377 h·ng/mL, compared to 301 to 359 h·ng/mL for 2 mg risperidone; and LYN-005 28 mg ranged from 472 to 575 h·ng/mL, compared to 687 to 753 h·ng/mL for 4 mg risperidone. These figures reflect measurements taken across different time periods in the study design. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03507127 · results posted 17 May 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03507127) enrolled a very small number of participants — 3 people in the varenicline group and 2 in the placebo group. Only 1 person in each group completed the study. The trial was measuring things like cigarette cravings, nicotine withdrawal feelings, how satisfying cigarettes felt, and how long it took before someone smoked again after a period of not smoking. The reported data shows that on a craving scale (where 1 means no craving and 7 means very strong craving), the varenicline group scored 3.12 on average compared to 4.41 for the placebo group. For a withdrawal symptom scale covering feelings like anger, anxiety and low mood (rated 0–4), the varenicline group averaged 1.45 versus 0.85 for the placebo group. On a scale measuring how satisfying cigarettes felt (1–7), the varenicline group scored 5.33 compared to 3.43 for placebo; the "reward" feeling scale showed scores of 4.00 and 4.30 respectively. For how long participants went before smoking again, the reported data shows the varenicline group lasted an average of 8 hours and the placebo group lasted 24 hours. A separate scale measuring psychiatric symptoms showed very similar scores in both groups (1.33 versus 1.37). It is important to note that because so few people took part and so few completed the study, these numbers should be understood only as reported observations from a very small pilot — they cannot be used to draw broad conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02845440 · results posted 19 April 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 1,165 people across five groups. The study was testing approaches to help people who smoke quit tobacco. The main approaches compared were: usual care (no extra support, called TAU), an "Automated Delivery" programme (AD), a Community Health Worker support programme (CHW), and a combination of both (AD+CHW). The trial was split into two groups of participants (Cohort 1 and Cohort 2). Cohort 1 had around 333–341 people per group, and Cohort 2 had around 77–78 people per group. Not everyone finished the study — for example, in the three main Cohort 1 groups, roughly 200–204 out of 333–341 people completed it. The reported data shows that for the main outcome — the number of people who had stopped smoking (confirmed by a breath test) at the two-year mark in Cohort 1 — 13 out of 333 people in the usual care group, 32 out of 336 in the AD+CHW group, and 19 out of 341 in the AD-only group were recorded as not smoking at that point. For the secondary outcomes, the reported data shows differences in how many people used quit-smoking medicines. For example, at the year-one check-in, 34 people in the usual care group, 72 in the AD+CHW group, and 30 in the AD-only group were recorded as using a specific medicine called varenicline. When looking across both cohorts combined at two years, the numbers of people who were not smoking were: 13 (TAU Cohort 1), 32 (AD+CHW), 19 (AD only), 11 (CHW Cohort 2), and 8 (TAU Cohort 2). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03868839 · results posted 2 March 2022

According to the results reported on ClinicalTrials.gov, this trial involved six people who were given a telmisartan pill. Five participants completed the study, while one did not finish. The trial was measuring changes in four substances found in the blood that are often associated with inflammation and oxidative stress in the body — specifically, Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin-6 (IL-6), High Sensitivity C-Reactive Protein (hs-CRP), and Glutathione. Blood levels of each substance were measured at the start of the study and again at four weeks, with the reported figures representing the change between those two time points. The reported data shows the following average changes from the start of the study to week four in the group taking telmisartan: TNF-alpha (a marker related to inflammation) changed by 1.10 pg/mL (picograms per millilitre, a very small unit of measurement); Interleukin-6 (another inflammation-related marker) changed by 4.61 pg/mL; High Sensitivity C-Reactive Protein (also linked to inflammation) changed by 2.34 mg/L (milligrams per litre); and Glutathione (a substance the body produces that relates to its defence against cell damage) changed by 537.00 uM (micromolar). The data does not indicate the direction of these changes (that is, whether levels went up or down), as that information was not included in the reported results. It is worth noting that this was a very small study with only six participants, and no comparison group (such as a group taking a dummy pill) appears to have been included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03870880 · results posted 23 February 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03870880) enrolled 215 participants in total across six groups, all of whom received injections of risperidone ISM (a long-acting injectable formulation) at either a 75 mg or 100 mg dose. Participants came from different backgrounds: some had previously received a placebo in an earlier study, some had already been on risperidone ISM, and some were brand new to the treatment. The trial measured changes in schizophrenia-related symptoms over approximately one year, primarily using a 30-item symptom rating tool called the PANSS (Positive and Negative Syndrome Scale), where lower scores indicate fewer symptoms. Of the 215 who started, 161 completed the study. The reported data shows that, on the primary outcome — the change in total PANSS score from the start to the end of the study — all six groups recorded a decrease (that is, a move toward lower symptom scores). The largest reported decreases were seen in participants who had previously been on placebo and then switched to risperidone ISM: a drop of 22.9 points in the 75 mg group and 18.9 points in the 100 mg group. Groups who had already been on risperidone ISM showed smaller changes (drops of 11.0 and 8.7 points respectively), and those who were entirely new to the medication showed the smallest reported changes (0.8 and 4.8 points). Similar patterns — with the placebo-switcher groups showing the largest decreases — were reported across the supporting measures, including subscales for positive symptoms, negative symptoms, and general symptom severity, as well as two clinician-rated global impression scales. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03345342 · results posted 9 December 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03345342) studied two forms of a long-acting injectable antipsychotic medication given once every three months (PP3M) or once every six months (PP6M) in people with schizophrenia. The trial ran in three stages: an open-label phase (where everyone knew what treatment was being given), a double-blind phase (where neither participants nor doctors knew which version was being received), and a follow-up phase. A total of 838 people entered the open-label stage, of whom 702 completed it and moved into the double-blind stage — 224 were assigned to the three-monthly injection group and 478 to the six-monthly injection group. Smaller numbers then entered a follow-up phase. The reported data shows that for the primary outcome — how long it took before a participant experienced a relapse (a return or worsening of symptoms) during the double-blind phase — no numerical result (such as a median number of days) was reported in the data submitted to ClinicalTrials.gov; the value was listed as "not available" for both groups. For the secondary outcomes, the reported data shows small average changes from the start of the double-blind phase to its end across both groups. On the PANSS scale (a 30–210 symptom rating tool, where higher means more severe), average scores changed by approximately −1.6 points in the PP3M group and −1.8 points in the PP6M group. On a clinician-rated severity scale (0–7, higher meaning more severe), the average change was 0.0 in both groups — meaning no average change was recorded. On a social functioning scale (1–100, higher meaning better functioning), average scores rose by about 1.1 and 1.0 points respectively. Around 70% of participants in the PP3M group and 66% in the PP6M group met the criteria for "symptomatic remission" (meaning their symptoms were rated as mild or lower across eight key measures) during the double-blind phase. On a satisfaction-with-social-roles questionnaire (scored 8–40, higher meaning greater satisfaction), average scores rose by 0.9 and 0.6 points in the two groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03817528 · results posted 2 November 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03817528) enrolled 4 participants, all in a single group receiving ITI-007 (also known as lumateperone). The trial was measuring schizophrenia symptoms using a tool called the Positive and Negative Symptom Scale, or PANSS — a standardised questionnaire where doctors rate 30 different symptoms, each on a scale from 1 (absent) to 7 (extremely severe). The total score can range from 30 (no symptoms present) to 210 (all symptoms at their most severe). Of the 4 people who started the trial, only 1 completed it, and 3 did not finish. The reported data shows that the primary outcome measured was the *change* in the total PANSS score from the start of the trial to the end. The reported average change in PANSS score was 11 points. Because the total score decreases when symptoms are rated as less severe, a reduction in score represents an improvement in rated symptoms — however, this summary is simply describing the number as reported, not drawing any conclusions about what it means. It is also worth noting that with only 1 participant completing the trial, this figure is based on very limited data, and no data was reported for secondary outcome measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01321177 · results posted 26 October 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 404 people in total — 223 in a group receiving "Integrated Treatment" and 181 receiving "Community Care." Of those who started, 147 in the Integrated Treatment group and 84 in the Community Care group completed the study. The trial was measuring quality of life and day-to-day functioning in people with schizophrenia over time, along with symptom levels and use of treatment services. The reported data shows that on the main measure — a quality-of-life scale scored from 0 to 126, where higher numbers mean better functioning — both groups started at similar points (around 51 for Integrated Treatment and 55 for Community Care) and both groups' scores rose over the course of the study, ending at approximately 67 and 65 respectively. On the symptom severity scale (scored 30–210, where higher means more severe symptoms), both groups began around 75–78 and both showed lower scores over time, finishing near 63 and 65. On the depression scale (0–27, higher meaning more depression), both groups also showed lower scores over time, ending at roughly 2.7 and 3.3. For use of treatment services, the Integrated Treatment group recorded an average of 4.53 services received compared to 3.67 for the Community Care group. It is worth noting that the reported data does not include information about whether any differences between the two groups were considered statistically meaningful (that is, whether they were likely due to the treatments rather than chance), so those figures cannot be interpreted here. The data was reported at multiple time points but time-point labels were not included in the structured results provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02968602 · results posted 21 October 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02968602) involved 32 people in total — 16 who received minocycline (an antibiotic) and 16 who received a placebo (a dummy treatment with no active ingredient). All 32 participants completed the study, with no dropouts recorded. The trial was looking at cigarette cravings in people with schizophrenia, using a standard 10-question survey called the Questionnaire for Smoking Urges-Brief (QSU-Brief). This survey gives a score between 0 and 100, where a higher number means a stronger urge to smoke. The reported data shows craving scores at two different time points after the start of the study. At the first time point (week 1), the minocycline group had an average craving score of 42.1, while the placebo group had an average score of 38.6. At the second time point (week 2), the minocycline group had an average score of 43.4, compared to 36.9 in the placebo group. These are the raw score figures as submitted; no further breakdown of how these compared to each participant's starting (baseline) score was included in the structured data provided to ClinicalTrials.gov. It is worth noting that the trial was very small, with only 16 people in each group, and the reported data does not include information on whether any differences between the two groups were considered statistically meaningful (that is, unlikely to be due to chance). No secondary outcome measure data was included in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04327843 · results posted 12 October 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT04327843) enrolled 19 participants, all of whom received a combination of a treatment called CAE (a type of adherence-focused support) alongside a long-acting injectable (LAI) medication — that is, a medication given by injection rather than a daily tablet. The trial tracked how consistently participants took their medications, as well as broader measures of their mental health and daily functioning, at the start of the study, at around 13 weeks, and again at around 25 weeks. Eighteen of the 19 participants completed all three assessment points. The reported data shows that on the main medication adherence questionnaire (called the TRQ, where a higher score means poorer adherence to tablets), participants' scores changed by minus 57 percentage points at one time point and minus 23 percentage points at another — meaning the scores moved in the direction of better reported adherence over time. Separately, 18 out of 19 participants received all of their scheduled LAI injections within the allowed time window. For the secondary measures, the reported data shows that participants' average score on a scale measuring attitudes toward psychiatric medication started at 7.89 and moved to 9.83 (on a scale where a positive number reflects a more positive attitude). A scale measuring psychiatric symptom severity started at an average of 27.00 and moved to 25.06 (lower is better). A clinician-rated overall condition score started at 2.88 and moved to 2.24 (lower is better). A scale measuring social and occupational functioning started at an average of 62.17 and moved to 68.39 (higher is better). It is worth noting that this was a single-group study with no comparison group, so all figures reflect changes within the same group of 19 participants only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03637296 · results posted 28 September 2021

According to the results reported on ClinicalTrials.gov, this trial involved 15 people in total — 10 in a group receiving a support approach called Critical Time Intervention (CTI) and 5 receiving Treatment as Usual (the standard care). All 15 participants completed the study. The trial was looking at what happened to people after they left hospital — specifically, whether they were readmitted to hospital and whether they attended follow-up appointments with medical or mental health services in the days after discharge. The reported data shows that for hospital readmissions, 3 out of 10 people in the CTI group were readmitted within 7 days of leaving hospital, compared with 0 out of 5 in the Treatment as Usual group. Within 30 days, 7 out of 10 in the CTI group were readmitted, compared with 0 out of 5 in the Treatment as Usual group. For outpatient medical follow-up appointments (that is, non-hospital doctor visits), the reported data shows 7 out of 10 CTI participants attended within 7 days and 9 out of 10 within 30 days, compared with 4 out of 5 in the Treatment as Usual group at both time points. For mental health outpatient follow-up, 1 out of 10 CTI participants attended within 7 days and 4 out of 10 within 30 days, compared with 0 out of 5 and 1 out of 5 respectively in the Treatment as Usual group. It is worth noting that this was a very small trial with only 15 participants across both groups, and the reported data does not include any statistical analysis figures to indicate how much weight can be placed on these numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01452919 · results posted 16 September 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT01452919) involved 123 people who first took an investigational medicine called LY2140023 in an open-label phase (meaning everyone received the same treatment and knew what it was). Of those 123 people, 103 completed that phase. The 103 who completed it then moved into a second, randomised phase — meaning they were randomly assigned to either continue on LY2140023 (53 people) or switch to a placebo, which is an inactive dummy treatment (50 people). The trial was primarily measuring whether people experienced any symptoms that can sometimes occur when stopping a medicine, using a 30-item checklist where higher scores mean more severe symptoms (scored from 0 to 90). The reported data shows that, at the end of the randomised phase, the average symptom-checklist score for the placebo group was 13.23 out of 90, and for the LY2140023 group it was 11.50 out of 90. For the secondary measures, the reported data shows very small changes from the start of the randomised phase across a range of other scales — including checks for withdrawal-like symptoms, unusual body movements, muscle stiffness, and restlessness — with scores in both the placebo and LY2140023 groups generally changing by less than one point on their respective scales. Regarding suicidal thoughts or behaviours during the open-label period (tracked using a standard rating scale), the reported data shows that approximately 1.6% of participants showed a change in suicidal thinking from their starting point, and 0% showed a change in suicidal behaviour. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03019887 · results posted 9 September 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 139 participants, all in a single group called the "Dose Reduction" group. The study was measuring what happened when participants had their medication dose reduced — specifically, it was tracking how many people experienced a "relapse." Relapse was defined using a set of specific criteria, including a significant worsening of symptom scores on two standard rating scales, deliberate self-harm, the emergence of serious thoughts of suicide, or violent behaviour causing injury to another person or property damage. Of the 139 who started, 130 completed the study and 9 did not. The reported data shows that for the primary outcome — the number of participants who experienced a relapse — the figure recorded was 130. This appears to represent the number of participants included in the analysis rather than the number who relapsed, however the data as submitted does not clearly separate these two figures. Because of this ambiguity in how the result was reported, a clear count of how many people actually experienced a relapse cannot be confirmed from the submitted data alone. No secondary outcome measures were included in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02067975 · results posted 26 August 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02067975) involved people with schizophrenia-related disorders and healthy volunteers who were given either tryptophan (a naturally occurring amino acid) or a placebo (an inactive substance), then swapped to the other option two weeks later. In total, 93 people entered the study across all groups — including some who were screened but not assigned to a treatment. Of those who were assigned to a treatment, 65 people completed the full study. The trial was measuring whether tryptophan had any effect on verbal memory — that is, how well people could learn and recall a list of words — using a standardised test called the Hopkins Verbal Learning Test. Scores from this test were converted to a common scale (called a t-score, ranging from roughly -10 to 80) to allow comparisons between groups, with higher numbers representing better performance. The reported data shows that healthy volunteers scored around 53.9 on placebo and around 53.0 on tryptophan. For people with schizophrenia-related disorders, the reported scores were around 40.5 on placebo and around 38.5 on tryptophan. No other outcome measure data was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02129348 · results posted 16 August 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02129348) enrolled 77 people in total — 38 in the lithium treatment group and 39 in the placebo group (a placebo is a dummy treatment with no active ingredient). By the end of the study, 29 people in each group had completed it. The trial was looking at agitation and aggression symptoms, primarily using a rating tool called the Neuropsychiatric Inventory (NPI) Agitation/Aggression scale, which runs from 0 to 12, where a higher score means more severe symptoms. The reported data shows that on the primary measure — the NPI Agitation/Aggression score — the lithium group had an average score of 3.2, while the placebo group had an average score of 2.5. For the secondary outcomes, the trial also tracked how many participants were considered "responders" (meaning their overall symptom score dropped by at least 30% and a clinician also rated their behaviour as improved): 12 out of the lithium group and 7 out of the placebo group met this definition. On a separate clinician-rated behaviour change scale, 12 participants in the lithium group and 8 in the placebo group showed scores in the improvement range. A scale measuring manic-type symptoms returned average scores of 3.1 (lithium) and 1.1 (placebo). Two scales used to track physical side-effect-type symptoms — one covering general bodily symptoms and one assessing movement-related signs — returned very similar average scores between both groups (0.6 vs 0.7, and approximately 0.0 vs 0.0, respectively). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03404219 · results posted 10 August 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03404219) enrolled 31 participants, all placed in a single intervention group — there was no separate comparison or placebo group. All 31 participants completed the study. The trial was measuring changes in social functioning and social engagement in people with schizophrenia, using established questionnaire-based rating scales administered by a clinician, as well as brief self-reported check-ins collected twice a day over the two-month intervention period. The reported data shows the following numbers at the end of the study. On the Social Functioning Scale — a tool where a higher score (out of a possible 247) indicates better day-to-day social functioning — the reported average score was 108 out of 247. On the Quality of Life Scale's Interpersonal Relations section — which looks at things like social networks and relationships, scored from 0 to 48 with higher being better — the reported average score was 2.60 out of 48. For the secondary outcome, which involved participants rating their own recent social interactions twice daily (covering things like how well they felt they communicated and whether interactions felt worthwhile, on a scale of 1 to 4), the reported average composite score across the intervention period was 1.35. It is worth noting that the data submitted does not include the starting (baseline) scores alongside these figures, so the size of any change from the beginning to the end of the study cannot be calculated from what was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02810964 · results posted 27 July 2021

According to the results reported on ClinicalTrials.gov, this trial involved 64 people in total — 32 in a group taking a sulforaphane supplement (a compound found in vegetables like broccoli) and 32 taking an identical-looking placebo (a dummy pill with no active ingredient). All 64 participants first went through a two-week lead-in period where everyone took a placebo, followed by a 16-week period where half took the supplement and half continued with the placebo, without anyone knowing which they were receiving. The trial was primarily measuring changes in psychiatric symptoms, and also looked at thinking and memory skills, as well as several blood markers related to inflammation and immune activity. The reported data shows that for the main measure — a psychiatric symptom rating scale called the PANSS, where higher scores mean more severe symptoms — the sulforaphane group started with an average score of 81.0 and finished at 81.7, while the placebo group started at 81.5 and finished at 79.7. For the thinking and memory tests (scored on a scale where 50 is the average for a healthy reference population), the sulforaphane group went from 25.0 to 26.8, and the placebo group went from 19.5 to 22.8. The reported data also shows various blood markers — including C-reactive protein, Pentraxin-3, two immune-related proteins, and Interleukin-6 — were measured at the start and end of the study in both groups, with the specific numbers for each listed in the trial record. Three participants in each group did not complete the 16-week treatment phase, though the reasons were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02417142 · results posted 15 June 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 70 people in total — 35 in the experimental treatment group and 35 in the placebo (inactive treatment) group. The trial was measuring two things in people with schizophrenia: "negative symptoms" (such as reduced emotional expression, low motivation, and social withdrawal, measured using a rating tool called the SANS, where higher scores mean more severe symptoms out of a maximum of 125) and cognitive ability (thinking and memory skills, measured using a battery of tests called the MCCB, where a score around 50 represents what would be expected in the general population). Of those who started, 19 people in the experimental group and 22 in the placebo group completed the study. The reported data shows that for negative symptoms (SANS scores), both groups started at similar levels — around 33–34 points — and both groups' scores remained in a broadly similar range throughout the study, finishing at approximately 35 points (experimental group) and 35 points (placebo group) at the final time point. For the cognitive ability scores (MCCB), both groups also started at similar levels — roughly 27 points — which is well below the average expected for the general population. The reported data shows that by the end of the study, scores in both groups had moved slightly upward, with the experimental group reaching approximately 31 points and the placebo group approximately 34 points at the final time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03822416 · results posted 25 May 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03822416) involved 38 people in total — 19 in an intervention group and 19 in a control group. One person from each group did not complete the trial, leaving 18 in each group at the end. The trial was measuring smoking-related outcomes, specifically whether participants stopped smoking for at least 7 days in a row, whether they made at least one serious attempt to quit for 24 hours or more, and how much their daily cigarette use changed. These were measured at two points: 8 weeks and 6 months after joining the trial. The reported data shows the following numbers. For the main outcome — going without smoking for 7 days straight — at 8 weeks, 5 people in the intervention group and 3 in the control group achieved this; at 6 months, 4 in the intervention group and 5 in the control group did so. For quit attempts of at least 24 hours, at 8 weeks, 13 intervention participants and 7 control participants reported making one; at 6 months, 18 intervention and 10 control participants reported doing so. For the reduction in cigarettes smoked per day, the reported data shows the intervention group reduced by an average of 5.6 cigarettes per day at 8 weeks and 4.84 at 6 months, while the control group reduced by an average of 11.59 cigarettes per day at 8 weeks and 8.03 at 6 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03275766 · results posted 12 May 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03275766) looked at a brain stimulation technique called TMS (transcranial magnetic stimulation) as a potential treatment for psychomotor slowing — that is, the physical and mental sluggishness that can occur with certain conditions. A total of 45 people were enrolled across four groups: one group received stimulation aimed at a brain area called the DLPFC in a "facilitatory" (activating) way; two groups received stimulation aimed at a different brain area called the preSMA/SMA, one in a facilitatory way and one in an "inhibitory" (calming) way; and a fourth group received sham (inactive/pretend) TMS as a comparison. Not everyone who started the trial finished it — across all four groups, only 23 people completed the study. The reported data shows that the main thing being measured was the number of people in each group who showed a meaningful improvement — defined as a greater than 30% reduction in their score on a specialist rating scale for psychomotor slowing (the Salpêtrière Retardation Rating Scale) by week three. According to the results reported on ClinicalTrials.gov, in the DLPFC facilitatory group 4 out of 12 participants were counted as responders; in the preSMA/SMA inhibitory group, 9 out of 12 were counted as responders; in the preSMA/SMA facilitatory group, 0 out of 11 were counted as responders; and in the sham TMS group, 3 out of 10 were counted as responders. The reported data shows that several secondary outcomes were also planned — including changes in the rating scale score, physical activity levels measured by a wrist device, catatonia severity, finger-tapping speed, and coin-rotation ability — however, no numerical results for any of these secondary measures were submitted to ClinicalTrials.gov and therefore cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01625000 · results posted 12 April 2021

According to the results reported on ClinicalTrials.gov, this trial involved 508 people in total across five groups. Participants were given one of three doses of an investigational medicine called MP-214 (3 mg, 6 mg, or 9 mg), a comparison medicine called risperidone (4 mg), or a placebo (a dummy treatment with no active ingredient). The trial ran for 6 weeks and was measuring changes in schizophrenia-related symptoms using two rating scales. Not everyone who started the trial finished it — for example, of the 133 people who started on MP-214 6 mg, 81 completed the study. The reported data shows that the main thing being measured was change in something called the PANSS total score — a 30-item scale where higher numbers mean more severe symptoms, and scores can range from 30 to 210. A negative number here means scores went down (i.e., symptoms were rated as less severe) over the 6 weeks. The reported changes were: MP-214 3 mg, minus 10.4 points; MP-214 6 mg, minus 13.8 points; MP-214 9 mg, minus 14.0 points; risperidone 4 mg, minus 20.2 points; and placebo, minus 9.5 points. For the second measure — the CGI-S, a 7-point scale of overall illness severity where lower is better — the reported changes were: MP-214 3 mg, minus 0.7; MP-214 6 mg, minus 0.8; MP-214 9 mg, minus 0.7; risperidone 4 mg, minus 1.2; and placebo, minus 0.6. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02796144 · results posted 5 February 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 71 people across three groups: 23 received a combination of two medications (lorcaserin and metformin), 24 received lorcaserin on its own, and 24 received a placebo (a dummy treatment with no active ingredients). The trial ran for up to 52 weeks and was measuring changes in body weight and several blood test results, including different types of cholesterol and fats in the blood (triglycerides). Not everyone completed the study — 18, 21, and 18 people finished in each group respectively. The reported data shows that, from the start of the trial to the last study visit, the group taking the lorcaserin and metformin combination had an average change in body weight of minus 13.05 pounds, compared to minus 3.02 pounds in the placebo group. The lorcaserin-only group had an average change of minus 5.18 pounds, again compared to the same placebo figure of minus 3.02 pounds. For blood results, the reported data shows changes in HDL cholesterol (often called "good" cholesterol) of +3.8, +1.45, and −0.78 mg/dL for the combination, lorcaserin-only, and placebo groups respectively. LDL cholesterol (often called "bad" cholesterol) changed by −7.60, −10.86, and −6.83 mg/dL across the three groups. Triglycerides (fats carried in the blood) changed by −18.60, −19.68, and −3.11 mg/dL, and total cholesterol changed by −9.05, −13.45, and −9.21 mg/dL across the same three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02287584 · results posted 23 December 2020

According to the results reported on ClinicalTrials.gov, this trial involved 580 adults with a psychotic disorder. In the first part of the trial (a double-blind phase, where neither participants nor researchers knew who was receiving which treatment), participants were randomly assigned to receive either a placebo (an inactive treatment), a 40 mg dose of a patch-based medicine called DSP-5423P, or an 80 mg dose of the same medicine. After six weeks, those who completed this phase moved into a second, open-label phase (where the treatment given was known) lasting up to around a year, during which the dose could be adjusted flexibly. The reported data shows that the main thing being measured was change in a symptom-rating scale called the PANSS — a 30-item interview-based questionnaire where a higher score means more severe symptoms, ranging from 30 to 210. At the start of the trial, average scores across all three groups were similar (around 99–102 points). After six weeks, the reported average score reductions were: 10.8 points in the placebo group, 16.4 points in the 40 mg group, and 21.3 points in the 80 mg group. The reported data also shows the number of participants whose scores dropped by 20% or more (considered a "response"): out of 80 placebo participants assessed, 32 met this threshold; out of 99 in the 40 mg group, 49 did; and out of 107 in the 80 mg group, 55 did. For the longer open-label phase, the reported data shows that around 62–71% of participants were still in the study at 28 weeks, and around 44–52% remained at 52 weeks, though the 52-week figure applied only to participants in Japan. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02970305 · results posted 22 December 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02970305) enrolled 403 people — 201 in the pimavanserin group and 202 in the placebo (dummy treatment) group. The trial ran for 26 weeks and was measuring whether pimavanserin had any effect on the "negative symptoms" of schizophrenia. Negative symptoms refer to things a person may lack or lose — such as emotional expression, motivation, and social engagement — rather than experiences like hallucinations. The main tool used to measure this was a questionnaire called the NSA-16, which is scored from 16 to 96, where a higher number means more severe symptoms and a lower number (a reduction from the starting score) would indicate fewer symptoms over time. The reported data shows that at the start of the trial, both groups had very similar average NSA-16 scores — around 61.8 for the pimavanserin group and 61.0 for the placebo group. By week 26, the pimavanserin group's average score had dropped by 10.5 points, while the placebo group's average score had dropped by 8.8 points. For the secondary measures, the reported data shows similarly close results between the two groups. On a scale measuring personal and social functioning (PSP, scored 1–100, higher is better), both groups started near 47 and each improved by roughly 8 points. On a clinician-rated severity scale for negative symptoms (CGI-SCH-S, 1–7), both groups started around 4.6–4.7 and each reduced by 0.6 points. For the proportion of participants whose NSA-16 score improved by at least 20%, the reported data shows 93 out of the pimavanserin group and 84 out of the placebo group met that threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02170051 · results posted 27 November 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 55 people in total — 26 in a group receiving a combined therapy called CBSST-CCT (a type of cognitive and social skills training paired with computer-based exercises) and 29 in a comparison group called Goal-focused Supportive Contact (a structured supportive talking programme). The trial ran for about 12.5 weeks and was measuring changes in several areas, including negative symptoms (such as reduced motivation or emotional expression, which are common in some mental health conditions), thinking and memory skills, communication and financial abilities, social skills, and day-to-day functioning. Not everyone completed the study — 15 people finished in the CBSST-CCT group and 16 in the comparison group. The reported data shows the following changes in scores from the start to the end of the programme. For the primary measure — negative symptom severity (where higher scores mean more severe symptoms, on a 0–52 scale) — the CBSST-CCT group's average score changed by +0.07, and the comparison group's changed by −0.06, meaning both groups' scores stayed very close to where they started. For the secondary measures, the thinking and memory test (0–80 scale, higher is better) showed a change of +0.88 for CBSST-CCT and −0.01 for the comparison group. The communication and financial skills measure (0–100 scale) changed by +3.17 and +1.39 respectively. Social skills (2–10 scale) changed by +0.18 and +0.05. Day-to-day functioning (30–150 scale) changed by +0.17 and +0.25. Finally, a self-reported independent living skills measure (0–1 scale) changed by +0.01 and −0.008 for each group. The reported data shows that all of these changes in scores were very small across both groups and both directions. It is important to note that this was a relatively small trial, and the results simply describe what was measured and recorded — no conclusions about whether one approach is better than another should be drawn from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04548622 · results posted 30 October 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants, all of whom completed the study with no drop-outs. The trial was looking at a brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) — a non-invasive procedure that uses magnetic pulses directed at the brain — applied to both sides of the head in people with schizophrenia. The study used a rating tool called the PANSS (Positive and Negative Syndrome Scale) to measure the severity of schizophrenia-related experiences before and after the treatment. All 15 participants were in a single group; there was no comparison or control group. The reported data shows the following PANSS scores before and after the rTMS sessions. For hallucination-related experiences (scored on a scale of 1 to 7, where higher means more severe), the average score was reported as 5.19 before and 4.19 after. For a cluster of symptoms sometimes called "negative symptoms" — things like reduced motivation or emotional expression — (scored on a scale of 7 to 49), the average score was reported as 16.9 before and 12.53 after. For the overall PANSS total score (which ranges from 30 to 210), the average was reported as 67.8 before and 53.2 after. In each case, the scores reported after treatment were lower than those reported before, meaning participants on average rated as having less severe symptoms at the later time point on these scales. It is worth noting that because there was only one group and no comparison group, the reported data on its own does not allow conclusions about what caused any changes in scores. No information about side effects or safety was included in the structured data submitted, so that data was not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02032680 · results posted 20 October 2020

According to the results reported on ClinicalTrials.gov, this trial involved 30 participants across two groups. Twenty-two people were enrolled in an online (web-based) family education and support program, and eight people were enrolled in an in-person group program involving multiple families. The trial was measuring how well participants achieved a personal goal they had set for themselves at the start of the study, using a tool called the Goal Attainment Scale. This scale rated goal achievement from 0 (lowest) to 4 (highest). Of those who started, 16 people completed the online program and 7 completed the in-person program. The reported data shows how participants in each group were spread across the four levels of goal achievement at the end of the study. In the online group, about 6% of participants scored at the lowest level (0), around 38% scored at level 1, roughly 19% scored at level 2, and about 38% scored at the highest level (3 or above). In the in-person group, about 14% scored at the lowest level (0), none scored at level 1, around 29% scored at level 2, and roughly 57% scored at the highest level. Note that the data as submitted uses four score categories but the exact labels for each level were not fully detailed in the structured results provided. It is worth noting that both groups were quite small, which means these percentages are based on a limited number of people. The reported data shows the spread of scores across the groups, but no further statistical comparison between the two groups was included in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03757988 · results posted 21 September 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 17 adults in a single group who took part in a structured walking programme. Sixteen of the 17 participants completed the study, and one did not finish. The trial was measuring a range of things, including how far participants could walk in six minutes (as a measure of physical fitness), as well as changes in feelings of loneliness, symptoms related to psychosis, body mass index (BMI — a ratio of weight to height), and diastolic blood pressure (the lower number in a blood pressure reading) — all tracked from the start of the programme through to 24 weeks, and again at a follow-up check around week 28. The reported data shows that, on average, participants walked about 92 metres further in the six-minute walk test at the end of the 24-week programme compared to when they started. From the end of the programme to the follow-up check at week 28, the average distance changed by about 6.65 metres. For the loneliness scale (where higher scores mean greater loneliness, on a range of 20–80), the reported average change from the start to week 24 was 0.133 points, and from week 24 to week 28 it was minus 1.778 points. For the psychosis symptom scale (where higher scores mean more severe symptoms, on a range of 30–210), the average change from the start to week 24 was 8.267 points, and from week 24 to week 28 it was minus 2.778 points. The reported data shows BMI changed by an average of 0.280 kg/m² from the start to week 24, and by 0.022 kg/m² from week 24 to week 28. Diastolic blood pressure showed an average change of 5.667 mmHg from the start to week 24, and 5.333 mmHg from week 24 to week 28. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03338673 · results posted 2 September 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 12 people in total, split into two groups of 6. It was a crossover-style study, meaning participants experienced both a "dual therapy" (two treatments combined) phase and a "mono therapy" (single treatment) phase, just in different orders. One person from each group did not complete the study, leaving 5 finishers in each group. The trial was measuring two things: how many people stuck with the combined treatment phase all the way through (called "retention"), and how satisfied participants said they were with the combined treatment, rated on a scale of 1 to 10. The reported data shows that when it came to completing every session of the combined treatment phase, 4 out of the "Dual Therapy First" group did so, compared to 5 out of the "Mono Therapy First" group. For satisfaction, participants rated the combined therapy on a 1-to-10 scale (where 10 means most satisfied). The "Dual Therapy First" group reported an average score of 9.40 out of 10, while the "Mono Therapy First" group reported an average score of 8.60 out of 10. No other outcome measures were included in the data submitted to ClinicalTrials.gov. It is worth noting that this was a very small trial with only 12 participants, and the data as reported does not include any measures of whether the treatment changed symptoms or health outcomes — only whether people stayed in the study and how they rated their experience with the combined therapy. No safety or side-effect data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03345979 · results posted 11 August 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03345979) enrolled 200 people in total — 99 received a long-acting injectable medication called aripiprazole lauroxil, and 101 received another long-acting injectable called paliperidone palmitate. The trial was measuring changes in participants' scores on a standard psychiatric rating scale called the PANSS (Positive and Negative Syndrome Scale), which is used to assess the severity of schizophrenia symptoms. The scale runs from 30 to 210, where a higher number means more severe symptoms, and a lower number (or a drop in score from the starting point) means fewer reported symptoms. Of the 200 who started, 56 in the aripiprazole lauroxil group and 43 in the paliperidone palmitate group completed the study. The reported data shows that both groups had lower PANSS scores compared to where they started at several points during the trial. At 4 weeks, the aripiprazole lauroxil group's average score had dropped by 17.4 points from their starting score, while the paliperidone palmitate group's average score had dropped by 20.1 points. At 9 weeks, the reported drops were 19.8 points and 22.5 points respectively. By 25 weeks, the aripiprazole lauroxil group showed an average drop of 23.3 points, and the paliperidone palmitate group showed an average drop of 21.7 points. The trial also reported similar figures using a different statistical method (called a "least squares mean," which adjusts for variations in the data), and those numbers were broadly consistent with the figures above. It is worth noting that fewer participants completed the trial than started it — particularly in the paliperidone palmitate group — which means the results at later time points are based on a smaller number of people than were originally enrolled. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03649815 · results posted 4 June 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03649815) involved 38 participants who all completed the study — none dropped out. The trial looked at the use of a mobile health (mHealth) technology app, referred to as "A4i," and measured three main things: participants' mental health symptom levels, how engaged they were in their own recovery process, and how consistently they took their medication. The reported data shows the following scores at the end of the study. For mental health symptoms, participants were assessed using a 53-question tool called the Brief Symptom Inventory (BSI), where higher scores mean more symptoms. The overall symptom score reported was 41.66 out of a possible 212. Scores across the nine specific symptom areas (such as anxiety, depression, and others) ranged from approximately 1.97 to 6.37 out of their respective maximums. For recovery process engagement — measured on a scale where higher means more engagement in one's own recovery — the reported adjusted score was 7.45 out of a possible 30. For medication adherence, participants were assessed on a scale from 0 to 100, where 100 means perfect adherence; the reported average score was 98.94. It is worth noting that the data as submitted does not include comparison scores from before the study began or from a control group, so these numbers represent the group's scores at the point of measurement only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02983058 · results posted 2 June 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 12 people in total — 7 who had been diagnosed with a psychotic spectrum disorder and 5 who were unaffected first- or second-degree relatives of someone with such a diagnosis. The trial was measuring the level of activity of a specific brain receptor called mGluR5 (a protein on brain cells that receives chemical signals) using a brain-scanning technique called PET imaging. The main area of the brain being looked at was the dorsolateral prefrontal cortex — a region toward the front of the brain involved in thinking and decision-making. It is worth noting that of the 12 people who started the trial, only 4 completed it (2 from each group), and the remaining 8 did not finish. The reported data shows that in the main brain region measured (the prefrontal cortex), the mGluR5 binding level — expressed as a value called total distribution volume, which is a measure of how much the radioactive tracer used in the PET scan was taken up in that area — was reported as 13.58 mL/cm³ in the group with psychotic spectrum disorders and 11.12 mL/cm³ in the unaffected relatives group. For the secondary measurements, the reported data shows that in the hippocampus (a brain region involved in memory), the figures were 10.61 mL/cm³ for the disorder group and 11.29 mL/cm³ for the relatives group. In the primary visual cortex at the back of the brain, the reported values were 10.50 mL/cm³ and 8.74 mL/cm³ respectively. It is important to note that the number of people who completed this trial was very small (just 4 participants), which the researchers themselves would need to take into account when interpreting these figures. No further statistical analysis results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03434457 · results posted 27 May 2020

According to the results reported on ClinicalTrials.gov, this trial followed a single group of 630 children and their families, tracking them from before birth through to 72 months (six years) of age. The trial was measuring several aspects of how children grow and develop over time, including their thinking and learning skills, their temperament (personality traits and emotional responses), their social and emotional development, any behaviour problems, and their readiness for school. The reported data shows the number of participants who completed each assessment at the various time points — rather than a score or rating for each measure. For the thinking and learning assessments (Bayley Scales), between 422 and 524 children provided data across the different time points. For the temperament questionnaires — one used for infants and one for toddlers — the reported data shows between 387 and 475 participants at the infant stage and between 420 and 433 at the toddler stage. For social and emotional development, between 471 and 485 participants were measured. For behaviour problems, between 310 and 366 participants provided data, and for school readiness, between 322 and 366 participants were assessed. No summary scores or ratings for any of these measures were reported in the structured results submitted to ClinicalTrials.gov — only the number of participants assessed at each time point was provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03627195 · results posted 8 May 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03627195) involved 40 people in total. Participants were divided into six groups: five groups of six people each received a single injection of lurasidone (an existing medication) at one of five different doses — 30 mg, 75 mg, 150 mg, 300 mg, or 450 mg — while a sixth group of ten people received a placebo (an inactive injection). The trial was measuring how the drug moved through the body at different doses, as well as tracking any unwanted side effects or health events that occurred. The reported data shows that the primary measurements tracked how much of the drug entered the bloodstream and how long it stayed there. The peak amount of lurasidone detected in the blood (the highest level reached) rose with each higher dose — from 1.08 ng/mL (nanograms per millilitre, a very small unit of concentration) in the 30 mg group up to 9.50 ng/mL in the 450 mg group. The placebo group showed a level of zero, as expected. A second measure looked at the total exposure to the drug over time (essentially the "area under the curve" — a way of adding up drug levels across all the hours it was in the body). This also increased with dose, from 628 in the 30 mg group to 7,490 in the 450 mg group (measured in ng\*h/mL), with zero in the placebo group. Regarding unwanted health events, the reported data shows that the number of participants who experienced at least one adverse event (an unwanted health event during the study) ranged from 2 to 5 people across the lurasidone dose groups, and 5 out of 10 people in the placebo group also reported at least one such event. No serious adverse events were reported in any group, and only one person — in the 30 mg lurasidone group — did not complete the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01913327 · results posted 20 April 2020

According to the results reported on ClinicalTrials.gov, this trial compared two medications — aripiprazole and risperidone — in a very small number of participants. Only three people were enrolled in total: one in the aripiprazole group and two in the risperidone group. Of those, one person in the risperidone group did not complete the study. The trial was designed to look at brain activity using a type of brain scan called fMRI (which tracks blood flow in the brain as a measure of activity), how well participants performed on thinking and memory tasks, and common symptoms of schizophrenia. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — this includes the primary measure of brain activity during cognitive tasks, the secondary measures of thinking task performance and brain responses to a single dose of modafinil (a wakefulness-promoting medicine used here as a test), and the additional measure of psychiatric symptoms. In other words, while the trial recorded what it intended to measure, no actual numbers or findings from those measurements were reported in the structured results data. Because the trial enrolled only three participants and no outcome data was reported, there are no findings to describe from this study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01668355 · results posted 28 February 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT01668355) enrolled 331 people — 164 in a programme called SMI-PACT (a specialised primary care model for people with serious mental illness) and 167 receiving usual care. The trial was measuring several things: how often participants received routine health screenings (such as checks of body weight, blood pressure, cholesterol, and blood sugar); their physical and mental quality of life; and their satisfaction with their care. The reported data shows the following numbers at the end of the study. For health screenings, more participants in the SMI-PACT group received each type of check compared to the usual care group — for example, 88 versus 41 participants were reported as having received lipid (cholesterol) screening, and 119 versus 85 received blood sugar screening. On the physical quality-of-life scale (scored 0–100, where higher means better), the reported scores were 38.9 for SMI-PACT and 37.2 for usual care. On the mental quality-of-life scale (same range), scores were 42.3 versus 37.6. For care satisfaction measured by one survey tool (ACES, scored 0–100), scores were 68 versus 66.7; on a second satisfaction measure (PACIC, scored 1–5), scores were 2.7 versus 2.9. A separately reported measure of psychosis-related symptoms (scored 0–4, where higher means worse) showed 0.88 for SMI-PACT and 0.65 for usual care. It is worth noting that the reported data does not include detail on how meaningful the differences between the two groups were in a statistical sense, so the raw numbers above should be read simply as what was recorded, not as a definitive comparison. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01470781 · results posted 26 February 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 72 people in total — 39 in the Cognitive Remediation group and 33 in the Computer Control group. The trial was measuring whether a cognitive remediation program (a type of structured brain-training intervention) made a difference to thinking and memory skills, mood symptoms, and everyday functioning in people who took part. By the time the trial was completed, 21 people in each group had finished all assessments, meaning a notable number of participants did not complete the study — 18 in the Cognitive Remediation group and 12 in the Computer Control group. The reported data shows that the main thing being measured was performance on a standardised thinking-and-memory test called the MCCB, where scores are set up so that 50 represents the average in the general population. At the start, both groups scored similarly (around 45–46). The reported numbers at the final follow-up point showed the Cognitive Remediation group at 50.3 and the Computer Control group at 46.3. For the secondary measures — which looked at symptoms of mania, depression, and psychosis, as well as day-to-day community functioning and social and work functioning — the reported data shows the two groups had broadly similar scores across all time points, with no dramatic differences apparent in the numbers as reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00167934 · results posted 10 February 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT00167934) involved 164 people in total — 82 in a placebo group (receiving a dummy treatment) and 82 in an experimental group (receiving the treatment being studied). All 164 participants completed the trial with no drop-outs recorded. The trial was measuring two things over 12 weeks: changes in the amount of fat in the body (measured using a specialised scan called dual energy X-ray absorptiometry, which uses low-level X-rays to estimate body composition), and how well the body's muscles were responding to insulin to process sugar from the blood (known as glucose disposal). The reported data shows the following results, expressed as percentage change from the start of the trial. For total body fat, the placebo group showed a change of −0.51% (a very small decrease), while the experimental group showed a change of +2.03% (a small increase). For the measure of how muscles processed sugar in response to insulin, the placebo group showed a change of +0.27% and the experimental group showed a change of −0.35%. These are small differences in both directions between the two groups across both measures. It is worth noting that the results data submitted does not include any additional detail about whether these differences between the groups were considered meaningful in a statistical sense, so that information was not reported and cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01129882 · results posted 6 January 2020

According to the results reported on ClinicalTrials.gov, this trial involved 709 participants, all of whom received at least one dose of aripiprazole given as an injection (intramuscular depot — a slow-release injection into the muscle). The trial was conducted with a single group, meaning everyone received the same treatment with no comparison group. Of the 709 people who started, 431 completed the study and 278 did not finish. The trial was measuring two things: how many participants experienced severe side effects during the study, and how scores on a standard mental illness severity rating scale changed over time. The reported data shows that 50 out of 709 participants experienced what the trial defined as a severe treatment-related adverse event — meaning an unwanted health event serious enough to prevent the person from working or carrying out normal daily activities. Regarding the illness severity scale (called the CGI-S), scores are rated from 1 (not ill at all) to 7 (among the most extremely ill). The reported data shows an average change of −0.14 points from the start of the study to the last visit. This is a very small numerical shift on that scale. It is worth noting that because there was no comparison group in this trial, these numbers describe what was observed in this one group of participants only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01914393 · results posted 19 December 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT01914393) was a long-term follow-on study involving people who had previously taken part in one of three earlier trials (labelled D1050301, D1050325, and D1050326). A total of 702 participants entered the study across the three groups, and 378 completed it. The trial was measuring adverse events (unexpected or unwanted health events) and changes in symptom scores on a standard psychiatric rating tool called the PANSS (Positive and Negative Syndrome Scale), which rates the severity of symptoms on a scale where higher numbers mean more severe symptoms. The reported data shows that, when looking at unwanted health events across all 702 participants combined, 572 experienced at least one adverse event, 78 discontinued (stopped) the study because of an adverse event, and 77 experienced a serious adverse event. Regarding symptom scores — which were only reported for the group that rolled over from the first earlier trial (271 started, 156 completed) — the average PANSS total score at the start of this study was 76.0 out of a possible 210. The reported data shows the average score appeared to decrease over time, with changes of −11.9, −15.6, and −18.4 points recorded at successive measurement points (lower numbers indicating fewer reported symptoms). Similar downward trends across time were reported for the subscale scores measuring positive symptoms, negative symptoms, general symptoms, and excitability, though the specific time points for each measurement were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02085447 · results posted 9 December 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02085447) enrolled 30 people in a single group, labelled "CAE-L." The trial was measuring how well participants kept to their prescribed medications — including both tablets and long-acting injections — over a period of roughly 25 weeks. It also looked at participants' attitudes toward their medications and at certain symptoms. Of the 30 people who started, 26 completed the trial and 4 did not. The reported data shows the following numbers at the 25-week point. For tablet-taking, the questionnaire used (called the TRQ, which measures what percentage of doses were missed) recorded an average of 56.2% adherence when looking at the past week, and 15.2% when looking at the past month — noting that a score of 0% missed means perfect adherence and 100% missed means no doses taken at all, so these two figures reflect different recall periods rather than a direct contradiction. For long-acting injections, the reported data shows that 90.5% of scheduled injections were received within the allowed time window. On the secondary measures, the reported data shows an average score of 8.5 out of 10 on a medication attitudes scale (where higher means more positive attitudes), 4.0 out of 19 on a mood-stabiliser attitudes scale (where lower means more positive attitudes), and 21.2 out of a possible 49 on a scale measuring certain psychiatric symptoms (where higher scores indicate more symptoms). It is important to note that this trial had only one group and no comparison group, so the numbers above describe what was observed in those participants without a direct point of comparison. No data was reported for how things looked at the start of the study (the "screen" visit), so the size of any change over time was not included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01621737 · results posted 19 November 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT01621737) was designed to look at a group listed simply as "All Participants." The study planned to measure changes in symptoms of psychotic disorders using a tool called the PANSS (Positive and Negative Syndrome Scale), which rates 30 different symptoms — such as hallucinations, delusions, and mood disturbances — on a scale where higher scores indicate more severe symptoms. It also planned to measure overall functioning, general illness severity, improvement over time, thinking and memory skills, and emotional management abilities. The reported data shows that zero participants were recorded as having started, completed, or left the study early. Because no participants appear to have been enrolled, no numerical results were reported for any of the outcome measures — not for the primary PANSS symptom score, nor for any of the six secondary measures. In other words, the data fields for all outcomes are empty, and no findings were submitted. The reported data therefore contains no results that can be described or summarised in terms of what was found. It is not possible to draw any conclusions from this trial about the questions it set out to answer, as the data was not reported for any participant. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02716584 · results posted 19 September 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02716584) enrolled 53 people in total — 35 in a physical exercise group and 18 in a stretching exercise group. By the end of the study, 27 people in the physical exercise group and 13 in the stretching group had completed the trial. The trial was measuring several things at once: aerobic fitness (how efficiently the body uses oxygen during exercise), social functioning (how well people engage with others day-to-day), speed of information processing (how quickly the mind handles information), positive and negative feelings, and a broader snapshot of thinking and memory skills. The reported data shows the following changes from the start to the end of the trial (these are average change scores, meaning a positive number reflects an increase and a negative number reflects a decrease). For aerobic fitness, the physical exercise group showed a change of +4.0 units compared to +0.2 for the stretching group. For social functioning (scored out of 223, where higher is better), the physical exercise group showed a change of +3.7 points, while the stretching group showed −2.5 points. For information processing speed (scored out of 110), the physical exercise group showed −0.4 and the stretching group +2.3. For positive feelings (scored out of 80, higher being better), both groups showed a decrease — the physical exercise group by −5.6 and the stretching group by −8.9. For negative feelings (scored out of 80, where lower is better), both groups showed an increase — +3.8 for physical exercise and +2.6 for stretching. Finally, for the overall thinking and memory composite score, both groups showed very small changes close to zero (+0.01 for physical exercise and +0.06 for stretching). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00839852 · results posted 22 August 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 93 people who were given cariprazine, a medication being studied for schizophrenia. The trial ran for 48 weeks and was measuring changes in participants' symptoms over that time. Of the 93 people who started, 46 completed the full study period, while 47 did not finish. The primary thing being measured was a standard symptom checklist called the PANSS (Positive and Negative Syndrome Scale), which rates 30 different psychiatric symptoms on a scale where higher numbers mean more severe symptoms, and the total score can range from 30 to 210. The reported data shows that, on average, participants' PANSS total scores decreased by 38.5 points from the start of the study to week 48 — a negative change meaning scores moved in a lower direction on this scale. A second measure, called the CGI-S (Clinical Global Impressions-Severity scale), rates overall illness severity from 1 to 7, with higher numbers indicating greater severity. The reported data shows an average decrease of 2.0 points on this scale from the start to week 48, again representing a movement in the lower direction. It is worth noting that this trial had only one group — everyone received cariprazine — so there was no comparison group receiving a placebo or different treatment, which limits what can be concluded from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00288366 · results posted 6 August 2019

According to the results reported on ClinicalTrials.gov, this trial involved 49 people in total — 23 in a group taking a medicine called aripiprazole and 26 in a group taking a medicine called ziprasidone. All participants in both groups completed the study, with no drop-outs recorded. The trial was measuring changes in something called the HDL ratio — HDL is a type of cholesterol sometimes referred to as "good cholesterol," and the ratio is a way of tracking how levels of it change in the blood after switching medications. The reported data shows HDL ratio figures (measured in g/dL) for both groups at two time points — likely before and after the medication switch, though the data as submitted does not label these time points explicitly. For the aripiprazole group, the reported values were 39.7 and then 43.5. For the ziprasidone group, the reported values were 38.4 and then 42.3. Both groups appear to show a numerical increase between the two time points, though the submission does not include any further statistical detail or context explaining what those changes mean clinically. It is worth noting that the data as submitted to ClinicalTrials.gov is limited — for example, no secondary outcome measures were reported, and the time points for the measurements are not clearly labelled in the structured data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01874756 · results posted 2 July 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 95 people in total across four groups: 29 received a placebo (a dummy treatment with no active ingredient), 10 received a low dose of LY500307 (25 mg), 29 received a medium dose (75 mg), and 27 received a high dose (150 mg). The trial was measuring several things in people with schizophrenia: changes in so-called "negative symptoms" (such as reduced motivation or emotional expression, rated on a structured interview scale), changes in memory and thinking abilities, activity in certain brain regions during a memory task (measured by MRI), and two specific safety signals — whether testosterone levels dropped significantly or whether the heart's electrical rhythm was affected in a particular way. The reported data shows the following numbers for the main symptom rating scale (the NSA-16, where higher scores mean more severe symptoms): at the end of the study period, the placebo group scored around 48.2, the 25 mg group around 45.8, the 75 mg group around 45.3, and the 150 mg group around 41.4. For the memory and thinking tests, scores across all four groups were broadly similar throughout the trial, with no large differences between the groups reported in the data. On the brain-activity measure (reported as a "beta coefficient," a number describing the strength of a brain signal), values were also similar across groups, ranging roughly from 0.15 to 0.31 at different time points. For the two safety-related measures, the reported data shows that zero participants in any group experienced a significant drop in testosterone or a concerning change in heart rhythm. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02104752 · results posted 15 May 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 39 people in total — 18 in the curcumin (turmeric extract) group and 21 in the sugar pill (placebo) group. Most participants completed the study: 17 in the curcumin group and 19 in the sugar pill group. The trial was looking at whether curcumin had any effect on thinking and memory skills, brain activity, a protein linked to brain health, and psychiatric symptoms in people with schizophrenia. Measurements were taken at the start of the study, at four weeks, and again at eight weeks. The reported data shows that for the main outcome — a standardised thinking and memory test scored from 0 to 100 (where 50 is average and higher is better) — the curcumin group scored around 36.6 at the start, 36.3 at four weeks, and 35.8 at eight weeks. The sugar pill group scored around 32.9, 33.8, and 33.9 at those same time points. For the brain activity measure (where more negative numbers indicate a larger response, considered better), the curcumin group recorded approximately −2.2, −2.15, and −2.15 microvolts across the three time points, compared with −1.84, −1.99, and −1.68 for the sugar pill group. A blood protein called BDNF — sometimes associated with brain health — was measured in picograms per millilitre; the curcumin group recorded roughly 11,416, 15,395, and 14,828, while the sugar pill group recorded approximately 14,227, 13,288, and 10,219 across the three time points. The reported data also shows results for two symptom rating scales. On the psychiatric symptoms scale (scored 24–168, where lower is better), the curcumin group scored around 36.1, 35.1, and 36.1, and the sugar pill group scored around 38.1, 37.9, and 37.1. On the motivation and pleasure symptom scale (scored 0–36, where lower is better), the curcumin group scored approximately 14.2, 15.8, and 15.1, and the sugar pill group scored approximately 16.0, 16.2, and 17.9 across the three time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01969500 · results posted 13 May 2019

According to the results reported on ClinicalTrials.gov, this trial involved 51 people in total — 25 in a "Treatment as Usual" group and 26 in a "Mobile Application" group. Most participants completed the study (24 in each group). The trial was measuring two main things: how severe participants' psychotic symptoms were (such as hallucinations and delusions, scored on a scale from 0 to 68, where higher means more severe), and how well participants were functioning socially (scored on a scale from 0 to 45, where higher means better social functioning). Two secondary outcomes — how much people used the app and how satisfied they were with it — were listed but no numbers were reported for these. The reported data shows that for psychotic symptom severity, the Treatment as Usual group scored around 20.2 at one time point and 22.0 at another, while the Mobile Application group scored around 19.9 and 21.0 at those same points. For social functioning, the Treatment as Usual group scored around 27.6 and then 29.3, while the Mobile Application group scored around 26.0 and then 26.3. These are the raw scores recorded at the measurement points — no further breakdown of what drove those changes was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02002832 · results posted 1 April 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02002832) compared two medicines — lurasidone and risperidone — in people with psychotic disorders. A total of 194 people were assigned to each group (388 in total). The trial ran for 6 weeks and was primarily measuring changes in the severity of psychotic symptoms using a structured interview tool called the PANSS (Positive and Negative Syndrome Scale), which gives a total score between 30 and 210, where higher scores indicate more severe symptoms. The reported data shows that, on average, participants in the lurasidone group had a change of −31.2 points on the PANSS total score from the start to the end of the 6 weeks, while those in the risperidone group had an average change of −34.9 points. A negative number means the average score went down (i.e., symptoms were rated as less severe at week 6 than at the start). The trial also measured a secondary outcome using the CGI-I scale — a 7-point rating where a score of 1 means "very much improved" and 7 means "very much worse." The reported data shows the lurasidone group averaged a score of 2.0 and the risperidone group averaged 1.9 on this scale at week 6, both sitting close to the "much improved" mark on that rating system. It is worth noting that 28 people in the lurasidone group and 26 in the risperidone group did not complete the trial; the reasons for this were not detailed in the data provided here. No other outcome data beyond these two measures was included in the results submitted to ClinicalTrials.gov, so no further figures are available to report. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01594528 · results posted 22 March 2019

According to the results reported on ClinicalTrials.gov, this trial involved 49 people split into three groups: 17 people diagnosed with schizophrenia, 16 people diagnosed with major depression, and 16 people with no psychiatric diagnosis who acted as a comparison (control) group. All 49 participants who started the trial completed it. The trial was measuring physical movements, facial expressions, and sounds — counting how many of these "indicators" each person showed per minute during observation. The reported data shows the primary outcome was the number of these indicators recorded per minute across the three groups. The schizophrenia group recorded values of approximately 1.93, 0.45, and 0.25 indicators per minute across what appear to be different measurement categories or time points. The major depression group recorded approximately 0.23, 0.59, and 0.50 indicators per minute for the same categories. The control group (no psychiatric diagnosis) recorded approximately 0.40, 0.55, and 0.45 indicators per minute. The specific labels for each of these measurement categories were not included in the submitted data, so it is not possible to describe exactly what each set of numbers refers to beyond the general description of movement, expression, and sound indicators. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02507349 · results posted 1 February 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 2,443 people in total — 1,232 in the "Person-Centered Care" group and 1,211 in the "Measurement-Based Care" group. By the end of the study, 1,045 and 1,050 people respectively had completed it. The trial was measuring how two different approaches to mental health care compared across several areas, including how patients felt about their medication management, how involved they felt in decisions about their treatment, their sense of hope, how much they were bothered by medication side effects, their confidence in managing their own health, and the severity of their symptoms and difficulties. The reported data shows that on the main outcome measuring patients' experience of their medication treatment (scored 0–4, where higher means better), both groups scored around 3.0 at the start and finished similarly, with the Person-Centered Care group at about 3.07 and the Measurement-Based Care group at about 3.11. For shared decision-making (scored 0–100, where higher means more involvement in decisions), both groups started around 74 and finished close together — roughly 75.7 for Person-Centered Care and 76.3 for Measurement-Based Care. For the secondary measures, the reported data shows that scores for hopefulness (1–10), symptom difficulty (0–4), patient activation or confidence in self-managing health (0–91.6), and how much participants were bothered by side effects (1–10) were all broadly similar between the two groups by the end of the study, with both groups finishing in a similar range to where they began. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00709202 · results posted 25 January 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT00709202) enrolled 40 people in total — 19 in the betahistine group and 21 in the placebo (dummy treatment) group. Of those, 13 in the betahistine group and 15 in the placebo group completed the study, with 6 people in each group not finishing. The trial was measuring whether betahistine, compared to a placebo, was associated with changes in body weight and several related body measurements over the course of the study. The reported data shows that, on average, the betahistine group's weight changed by approximately −2.0 kg from the start to the end of the study, while the placebo group's weight changed by approximately −1.5 kg. These figures are "least squares estimates," meaning they are a statistical way of calculating an average change while accounting for other variables in the data. For body mass index (BMI — a number calculated from height and weight), the reported change was −0.55 units for the betahistine group and −0.56 units for the placebo group. Waist circumference increased by about 4.1 cm in the betahistine group and 2.5 cm in the placebo group, while hip circumference increased by about 1.8 cm and 1.4 cm respectively. Blood sugar (glucose) levels changed by +4.3 mg/dL in the betahistine group and +3.1 mg/dL in the placebo group, and cholesterol levels changed by approximately +1.1 mg/dL in both groups. The reported data shows relatively small numerical differences between the betahistine and placebo groups across all of these measurements. No further detail about the clinical meaning or statistical significance of these differences was included in the structured results submitted to ClinicalTrials.gov, so no further interpretation can be drawn from this data alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00690235 · results posted 16 November 2018

According to the results reported on ClinicalTrials.gov, this trial looked at whether pramlintide (an injectable medicine) was associated with weight loss in people with schizophrenia who had gained weight while taking olanzapine or clozapine (two antipsychotic medications). A total of 33 people took part — 17 in the pramlintide group and 16 in the placebo group (a dummy treatment with no active ingredient). Of those, 12 people in each group completed the full 16-week trial, with 5 people in the pramlintide group and 4 in the placebo group not finishing. The reported data shows that the primary outcome being measured was the average number of pounds lost over 16 weeks. According to the results reported on ClinicalTrials.gov, the pramlintide group had an average starting weight of 37 pounds (recorded as a measurement for that group), and the placebo group had an average of 40.5 pounds recorded for the same measure. It should be noted that the data as submitted does not clearly separate "weight lost" from "starting weight" in a way that allows a straightforward comparison to be described with confidence — only these two figures (37 and 40.5 pounds) were reported against the primary outcome measure, and no additional breakdown or secondary outcome data was included in the submitted results. No secondary outcome measure data was included in the results submitted to ClinicalTrials.gov, so those figures cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00711269 · results posted 19 October 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 460 adults in total across four groups: one group took a 40 mg dose of lurasidone (131 people), another took an 80 mg dose of lurasidone (131 people), a third group took a placebo — that is, a dummy treatment with no active ingredient (133 people) — and a fourth group took risperidone, an existing medication used as a comparison (65 people). The trial ran for 6 weeks and was mainly measuring changes in symptoms of psychosis using a structured interview tool called the PANSS (Positive and Negative Syndrome Scale), which produces a total score between 30 and 210, where higher numbers indicate more severe symptoms. By the end of the trial, 87, 83, 83, and 51 people had completed the study in each of the four groups respectively. The reported data shows that, on average, all four groups had lower PANSS total scores at week 6 compared to where they started — meaning scores moved in a downward direction across the board. The 40 mg lurasidone group's average total score fell by 6.1 points, the 80 mg lurasidone group's fell by 4.3 points, the placebo group's fell by 2.5 points, and the risperidone group's fell by 7.1 points. Similar downward patterns were reported for the subscores covering positive symptoms (such as hallucinations and delusions), negative symptoms (such as emotional withdrawal), and general symptoms (such as anxiety). The reported changes in those subscores were generally small across all groups. The reported data also shows that a large number of participants in every group experienced at least one treatment-emergent adverse event — that is, an unwanted medical occurrence that happened after starting the treatment: 105 out of 131 in the 40 mg lurasidone group, 103 out of 131 in the 80 mg lurasidone group, 101 out of 133 in the placebo group, and 53 out of 65 in the risperidone group. The number of people who stopped the trial specifically because of such an event was 18, 18, 27, and 7 in those same groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02164981 · results posted 2 October 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people across three groups: one group (23 people) received the active drug in both halves of the trial, one group (19 people) received a dummy treatment (placebo) first and then switched to the active drug, and one group (18 people) received a placebo throughout. The trial was measuring changes in schizophrenia-related symptoms using a standard questionnaire called the PANSS (Positive and Negative Syndrome Scale), which scores symptoms across 30 questions. A higher score on this scale means more severe symptoms, and the total score can range from 30 to 210. Not everyone who started finished the trial — 5 people in the drug-drug group and 3 in the placebo-drug group did not complete it, while all 18 in the placebo-only group did. The reported data shows the following for the main outcome — the change in total PANSS score over each two-week period. In the first two-week phase, the drug group's average score fell from about 83.6 to 77.6 (a drop of around 6.0 points), while the placebo group's average score fell from about 79.8 to 76.7 (a drop of around 2.5 points). In the second two-week phase, the drug group's average score fell from about 74.0 to 71.8 (a drop of about 1.8 points), while the placebo group's average score fell from about 78.8 to 74.7 (a drop of about 4.2 points). The reported data also shows that in the first phase, about 16.7% of people in the drug group had their total score drop by 20% or more, compared with 0% in the placebo group; in the second phase, 0% of the drug group reached that threshold compared with about 5.6% of the placebo group. For the smaller sub-scores covering positive symptoms, negative symptoms, and general symptoms, the reported changes were similarly modest across both groups and both phases. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02203838 · results posted 28 September 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02203838) enrolled 500 participants across four groups. The largest group — 408 people who were new to the study treatment — was called "De Novo Participants." The remaining three groups (totalling 92 people) were "rollover" participants who had previously been in a related trial and were grouped by what they had received before: a placebo (inactive treatment), a 90 mg dose, or a 120 mg dose of RBP-7000, a monthly injectable form of risperidone being studied for schizophrenia. The trial primarily tracked adverse events (unwanted health changes during the study) and also measured changes in schizophrenia symptom scores over time. The reported data shows that, among the De Novo group, 306 out of 408 participants experienced at least one treatment-emergent adverse event (a health change that occurred after the first dose). Injection-site reactions were reported in 52 De Novo participants. Regarding weight gain, 106 De Novo participants gained 7% or more of their starting body weight at some point during the study, and 67 gained 10% or more. Patterns across the smaller rollover groups were broadly similar in proportion, though the numbers were much smaller. Serious adverse events — defined as life-threatening, requiring hospitalisation, or causing lasting disability — were reported in 25 De Novo participants, and in 3 participants in each of the three rollover groups. The reported data also shows changes in symptom rating scores over the course of the study. On the PANSS scale (a 30-to-210 point measure of schizophrenia symptoms, where lower scores mean fewer symptoms), the De Novo group's average score changed by roughly −0.4 points from the start to the end of the study. The rollover groups showed larger average score changes by the end of the study — for example, −20.2 points in the rollover placebo group, −12.5 in the 90 mg rollover group, and −10.9 in the 120 mg rollover group (negative numbers mean scores moved in a lower direction on this scale). On the CGI-S scale (a 1-to-7 clinician rating of illness severity), average changes by end of study ranged from −0.2 in the De Novo group to −1.0 in the rollover placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02194933 · results posted 11 September 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 38 adults in total — 19 in a group receiving a 2 mg daily dose of a medication called brexpiprazole, and 19 in a group receiving a 4 mg daily dose. The trial was measuring whether brexpiprazole had any effect on brain activity in a specific region linked to impulse control (the right ventrolateral prefrontal cortex, or VLPFC), using a brain-scanning technique called fMRI. The scans were taken while participants completed two computer tasks designed to test self-control and the ability to stop a response. Of the 38 who started, 16 in the 2 mg group and 10 in the 4 mg group completed the study; the data was not reported on why the remaining participants did not finish. The reported data shows the following numbers for the main (primary) outcomes measured at the 6-week mark. For the first task (Go/No-go), the change in brain activity scores from the start of the study were 0.065 for the 2 mg group and 0.066 for the 4 mg group (baseline scores), and 0.049 and 0.043 respectively at week 6. For the second task (the stop-signal task), baseline scores were 0.052 (2 mg) and 0.095 (4 mg), changing to −0.001 and 0.003 at week 6. On the secondary outcomes, a self-reported questionnaire about impulsive personality traits (scored 30–120, where higher means more impulsive) showed changes of −2.6 (2 mg) and +1.0 (4 mg) at week 6, and −2.4 (2 mg) and −2.3 (4 mg) at week 3. The reported data shows similar small numerical changes across the brain-scan and questionnaire measures, though the trial's own results submission does not include a statistical comparison between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01829048 · results posted 20 August 2018

According to the results reported on ClinicalTrials.gov, this trial tested an investigational medicine called PF-02545920 against a placebo (an inactive treatment) across three groups, known as cohorts. In total, 37 people took part — 6 in Cohort 1, 8 in Cohort 2, 7 in a combined placebo group for Cohorts 1 and 2, 14 in Cohort 3, and 2 in a placebo group for Cohort 3. Two participants in Cohort 3 did not complete the trial; all others finished. The trial was primarily measuring two things: changes in scores on a scale that rates involuntary movement symptoms (called the ESRS-A scale, where higher scores mean more severe symptoms), and whether any participants reported thoughts of self-harm or suicide (using a separate checklist called the C-SSRS). The reported data shows that changes in movement symptom scores were very small across all groups. For Cohorts 1 and 2, the ESRS-A scores for participants taking PF-02545920 changed by between −0.3 and +0.5 points on the scale, while the placebo group's scores changed by between −0.1 and 0.0 points. For Cohort 3, participants taking PF-02545920 showed changes of between 0.0 and +0.6 points, while the placebo group showed no change (0.0) across all categories measured. Regarding the suicide-related checklist, the reported data shows that zero participants in any group — across all time points measured — gave a "yes" response to any of the categories assessed, including suicidal thoughts or self-harming behaviour. It should be noted that some detailed breakdown figures across all scale sub-categories were not individually labelled in the submitted data, so a full item-by-item comparison cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01412060 · results posted 6 July 2018

According to the results reported on ClinicalTrials.gov, this trial looked at a medication called cariprazine in people with schizophrenia. A total of 765 people started an initial open-label phase (where everyone received cariprazine). From there, the numbers gradually reduced at each stage — through stabilisation periods and screening steps — until 200 people were assigned to the final double-blind phase, where neither the participants nor the researchers knew who was receiving which treatment. In that final phase, 99 people were randomly assigned to receive a placebo (a dummy treatment with no active ingredient) and 101 people continued on cariprazine. The main thing the trial was measuring was how long it took before participants experienced a return of symptoms (called a "relapse") during the double-blind phase. The reported data shows this was measured using what is called the "25th percentile for time to relapse" — in plain terms, this is the point in time by which one quarter (25%) of participants in each group had experienced a relapse. According to the results reported on ClinicalTrials.gov, for those in the placebo group, that point was reached at 92 days. For those in the cariprazine group, that point was reached at 224 days. It is worth noting that only 16 out of 99 people in the placebo group and 18 out of 101 in the cariprazine group completed the full double-blind phase. The reported data shows these were the numbers submitted for the primary outcome measure only; no additional secondary outcome measure results appear to have been included in the data provided to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00981526 · results posted 19 June 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT00981526) enrolled 54 people in total — 26 in the telmisartan (active medicine) group and 28 in the placebo (dummy pill) group. By the end of the 12-week study, 22 people in each group had completed it. The trial was measuring things like insulin resistance (how well the body responds to the hormone insulin), blood fat levels, body composition, and psychiatric symptoms in participants who were taking the medicine telmisartan compared to those taking a placebo. The reported data shows that at 12 weeks, the telmisartan group had an insulin resistance score (called HOMA-IR — a higher number means more resistance) of approximately 2.0, compared to approximately 2.6 in the placebo group. For fasting triglycerides (a type of fat found in the blood), the telmisartan group recorded about 154 mg/dL and the placebo group about 177 mg/dL. For cholesterol, both groups had very similar LDL ("bad" cholesterol) readings of around 107 mg/dL, and HDL ("good" cholesterol) readings of about 41 mg/dL (telmisartan) and 43 mg/dL (placebo). Body fat percentage was reported as approximately 31.9% for the telmisartan group and 31.3% for the placebo group, while waist-to-hip ratio was 0.99 and 0.95 respectively. The reported data also shows that psychiatric symptom scores — measured using rating scales where higher scores indicate more severe symptoms — were broadly similar between the two groups at 12 weeks. The overall symptom scale (PANSS total) scores were about 67 for the telmisartan group and 71 for the placebo group, with comparable results across the positive symptom, negative symptom, and SANS subscales as well. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01127503 · results posted 8 May 2018

According to the results reported on ClinicalTrials.gov, this trial looked at a medication called metyrosine (brand name Demser) as a potential treatment for psychosis in people with a genetic condition called velocardiofacial syndrome (VCFS). The trial included two groups — one receiving metyrosine and one receiving a placebo (a dummy treatment with no active ingredient) — and was measuring both the safety and the effectiveness of the medication. The reported data shows that only 1 person was enrolled in each group, giving a total of just 2 participants across the entire trial. Both participants completed the study. The trial had two outcome measures: a primary one focused on safety, and a secondary one focused on effectiveness. However, no numerical results were submitted to ClinicalTrials.gov for either of these outcomes — the data fields are empty, meaning no figures are available to describe or summarise. Because no outcome data was reported, it is not possible to draw any conclusions about what the trial found regarding either the safety or effectiveness of metyrosine based on this record. It is also worth noting that with only 2 participants total, the trial was extremely small. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02421146 · results posted 30 April 2018

According to the results reported on ClinicalTrials.gov, this trial involved 12 people in total, split into four groups: healthy volunteers who received either a real brain stimulation technique called tDCS (transcranial direct current stimulation) or a "sham" (inactive/pretend) version, and patients who received either real or sham tDCS. Each group was very small — 2 to 4 people — and all participants who started the trial completed it. The trial was measuring changes in thinking and memory abilities using a standardised test called the RBANS, which covers areas like memory, attention, language, and visual skills. The score on this test is compared to a general population average of 100. The reported data shows the main (primary) result was the change in RBANS total score between the start of the trial and day 12. Healthy volunteers who received sham tDCS showed an average increase of 7 points, while those who received real tDCS showed an average increase of 5.25 points. Among patients, both the sham group and the real tDCS group showed a small average decrease in score — minus 1.5 points and minus 1.33 points respectively. The reported data also shows a secondary result: the change in RBANS score between the start of the trial and day 26. Healthy volunteers receiving sham tDCS had an average change of plus 0.5 points, while those receiving real tDCS had an average change of minus 7 points. Among patients, the sham group had an average change of minus 9.5 points, and the real tDCS group had an average change of minus 0.7 points. It is worth noting that the groups were extremely small, which limits how much can be read into these numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01411085 · results posted 23 March 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 10 participants, all of whom received a combination of two medications — risperidone and desipramine. The trial was measuring alcohol and other substance use, with the main focus on how many alcoholic drinks participants consumed per week. This was tracked using a method called the Timeline Followback, where participants were asked to look back and estimate how much they had been drinking. Of the 10 people who started the trial, 7 completed it and 3 did not. The reported data shows that, on average, participants reported consuming approximately 35.9 drinks per week. This figure was collected through self-reported estimates rather than direct observation. No comparison group (such as a placebo group) appears to have been included in this trial, so the reported number reflects only the single group who received both medications together. No other outcome figures were included in the data submitted to ClinicalTrials.gov. It is also worth noting that this was a very small trial with only 10 participants, and the results as submitted do not include data on any secondary outcomes — those were either not measured or not reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02566759 · results posted 6 February 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02566759) tested a drug called TAK-831 across four separate parts, enrolling a total of around 120 participants in all. The trial was designed as an early-phase study in healthy adult volunteers, and its main purpose was to gather information about how the body responds to different doses of TAK-831 — including single doses ranging from 10 mg up to 750 mg, multiple doses, and different forms of the drug (tablet vs. liquid suspension, taken with or without food). A placebo (a dummy treatment with no active ingredient) was given to some participants in each part for comparison. The reported data shows that the trial's primary measurements focused on tracking unwanted events and unusual readings after dosing — not on whether the drug treated any particular condition. For treatment-emergent adverse events (that is, any health event that appeared after taking the study drug or placebo), the reported percentages varied widely across groups: for example, 50% of placebo participants in Part 1 recorded at least one such event, compared with figures ranging from about 17% to 67% across the different TAK-831 dose groups in Part 1, and from 33% to 100% across dose groups in Part 2. For markedly abnormal laboratory test results (blood, chemistry, and urine tests), most groups recorded 0%, though one group (TAK-831 750 mg in Part 1) recorded 16.7% and one group (TAK-831 100 mg in Part 2) recorded 33.3%. For markedly abnormal vital signs (such as blood pressure, pulse, and temperature), reported figures ranged from 0% to 87.5% across the various groups and parts. The reported data for Part 3 and Part 4, and for several other secondary measurements, was not fully reported in the available data for all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02230384 · results posted 30 January 2018

According to the results reported on ClinicalTrials.gov, this trial involved 62 people in total — 30 in one group and 32 in the other. It used a "crossover" design, meaning everyone tried both the active drug (referred to as the JNJ drug) and a placebo (a dummy pill) at different times, with a rest period in between. The trial was looking at whether the drug made any difference to smoking quit attempts, withdrawal feelings, thinking skills, and psychiatric symptoms in people who smoked. The reported data shows that for the main thing being measured — the number of days participants went without smoking during a designated quit week — those taking the active drug averaged 0.46 days abstinent out of the five weekdays tracked, while those on the placebo averaged 0.54 days. For withdrawal symptoms (rated on a scale of 0 to 100, where higher means more symptoms), the active drug group scored 11.05 and the placebo group scored 11.52. A thinking-speed task measured in milliseconds showed 519 ms for the active drug group and 505 ms for the placebo group. Psychiatric symptoms, rated on a scale where 30 is the lowest possible score and 210 is the highest (higher being worse), averaged 42.23 on the active drug and 42.26 on placebo. The reported data shows that no participants in either group met the criteria for suicidal thoughts or behaviour, and no participants were reported to have had clinically significant abnormal blood test results during the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00688324 · results posted 23 January 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 36 participants in a single group. Of those, 28 completed the study and 8 did not finish. The trial was measuring levels of certain natural chemicals (called metabolites) in two specific areas of the brain — the anterior cingulate cortex (a region involved in decision-making and attention) and the right dorsolateral prefrontal cortex (a region involved in thinking and planning). Researchers used a brain-scanning technique called Magnetic Resonance Spectroscopy (MRS) — a type of scan that can detect chemical signals in the brain without surgery — to compare these chemical levels between participants who had a history of alcohol abuse or dependence at some point in their life, and those who did not. The reported data shows the following measured chemical levels (in millimoles per litre, a standard unit of concentration) in the anterior cingulate cortex. For choline, the alcohol history group measured 1.64 at one time point and 1.46 at another, while the no-alcohol-history group measured 1.54 and 1.58. For creatinine, the figures were 5.46 and 5.09 in the alcohol history group, versus 5.12 and 5.16 in the no-alcohol-history group. For glutamate, the readings were 7.44 and 7.06 versus 6.68 and 7.05. For N-acetylaspartate, the figures were 6.40 and 6.06 versus 5.99 and 6.14. For myo-inositol, the readings were 4.34 and 4.00 versus 4.00 and 4.35. In the right dorsolateral prefrontal cortex, choline levels were reported as 1.36 and 1.32 in the alcohol history group, and 1.30 and 1.71 in the no-alcohol-history group. The reported data also includes change figures for each measure, but no further outcome measures beyond choline in the prefrontal cortex were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00369577 · results posted 2 January 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 129 people across three groups: 43 received an inhaled placebo (an inactive substance with no medicine), 45 received a 5 mg dose of inhaled loxapine, and 41 received a 10 mg dose of inhaled loxapine. All participants were experiencing agitation at the time of the study. The trial was measuring changes in agitation levels using a specialised rating scale called the PANSS-EC — a scoring tool where trained observers rate five signs of agitation, with higher scores meaning more severe agitation. The reported data shows that, on the primary measure, all three groups showed a reduction in their PANSS-EC scores from the start of the study. The placebo group had an average reduction of about 5 points, the 5 mg loxapine group had an average reduction of about 6.7 points, and the 10 mg loxapine group had an average reduction of about 8.6 points. On a secondary measure of physical activity and behaviour (the BARS scale, rated 1–7), the reported average reductions from the starting point were approximately 0.9 points for placebo, 1.5 points for the 5 mg group, and 2.0 points for the 10 mg group. On a clinician's overall impression of improvement (the CGI-I, also rated 1–7, where lower numbers mean more improvement), the reported average scores were 3.19 for placebo, 2.53 for the 5 mg group, and 2.28 for the 10 mg group. When looking at how many participants were rated as "very much improved" or "much improved" on that same scale two hours after treatment, the reported numbers were 9 out of 43 in the placebo group, 22 out of 45 in the 5 mg group, and 25 out of 41 in the 10 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00570063 · results posted 20 December 2017

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called PF-02545920 (at a dose of 15 mg) compared to a placebo (a dummy treatment with no active ingredient) in people with schizophrenia. A total of 35 people took part — 24 in the active drug group and 11 in the placebo group. The main thing the trial was measuring was change in symptom severity scores on a standard clinician-rated questionnaire called the PANSS (Positive and Negative Syndrome Scale), which rates schizophrenia-related symptoms across 30 items, with higher scores meaning more severe symptoms. The reported data shows that, for the primary measure — the overall PANSS total score — participants in the PF-02545920 group started with an average score of about 98 and showed a reported average decrease (improvement in score) of around 19.8 points by day 21. Participants in the placebo group started at about 96 and showed a reported average decrease of around 18.3 points over the same period. For the secondary measures, the reported data shows similarly modest differences between the two groups across subscores measuring positive symptoms, negative symptoms, general symptoms, and two additional groupings of symptoms called Marder factors. Changes in both groups across all these subscores were broadly in a similar range, with no single subscore showing a large gap between the drug and placebo groups. It is also worth noting that a notable proportion of participants did not complete the trial — 15 out of 24 in the drug group and 8 out of 11 in the placebo group did not finish, though the reasons for this were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02855411 · results posted 4 October 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02855411) enrolled 35 participants and was studying a treatment called PF-04958242 compared to a placebo (a dummy treatment with no active ingredient). The trial was designed to measure changes in cognitive abilities — particularly working memory and everyday practical skills — over 12 weeks, using a set of standardised tests. It also looked at balance and coordination, thoughts of self-harm, and broader thinking and problem-solving abilities. The reported data shows that all 35 participants who started the study did not complete it — the data lists all 35 under "not completed," with zero recorded as having finished. Because of this, no numerical results were reported for any of the outcome measures, including the primary measures of working memory and everyday functioning, or any of the secondary measures such as balance, suicidal thinking, or overall cognitive scores. In other words, the measurements fields are empty across every outcome listed. The reported data shows no figures were submitted for what the assessments found, so it is not possible to describe what the results showed in terms of numbers or changes from the start of the study. The reason all participants did not complete the trial was not explained in the submitted data on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02477020 · results posted 29 September 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02477020) enrolled 164 adults — 81 in the placebo group and 83 in the TAK-063 group. The trial was measuring changes in schizophrenia symptoms over six weeks using a standard rating tool called the PANSS (Positive and Negative Syndrome Scale), which scores symptoms on a 30-to-210 scale where higher numbers mean more severe symptoms. A drop in score from the starting point indicates a reduction in symptom severity. The trial also tracked a clinician's overall rating of illness severity using a separate 1-to-7 scale. Of those who started, 51 in the placebo group and 55 in the TAK-063 group completed the study. The reported data shows that, for the main outcome at week 6, the placebo group's PANSS total score dropped by an average of about 14 points from their starting score, while the TAK-063 group's score dropped by about 20 points. For the secondary outcomes tracked across the earlier weeks (weeks 1–5), both groups showed score reductions at each time point, with the TAK-063 group generally showing larger reported drops than the placebo group at each week. Looking at the proportion of participants whose total PANSS score fell by at least 30% from their starting point by week 6, the reported data shows this occurred in about 43% of the placebo group and about 55% of the TAK-063 group. The reported data also shows changes in the clinician-rated severity scale (CGI-S), where a lower score means the clinician rated the person as less unwell. By week 6, the placebo group's average score on that scale dropped by about 0.76 points, while the TAK-063 group's dropped by about 1.19 points. Similar patterns were reported at each of the earlier weekly check-ins. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00423943 · results posted 29 September 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 33 people in total — 19 in the drug group and 14 in the placebo group. Of those, 16 in the drug group and 13 in the placebo group completed the study. The trial was looking at whether the drug had any effect on brain activity and mental performance, specifically on a task designed to measure how well people can prepare to make a difficult or "against instinct" response. Brain activity was measured using two techniques: fMRI (a brain scan that tracks blood flow) and scalp electrophysiology (which measures electrical activity in the brain). The reported data shows that on the accuracy test for the difficult task condition, both groups improved by a similar amount — about 8.6% in the drug group and 9.2% in the placebo group. For the fMRI brain signal measurement in a specific brain region called the locus coeruleus, the drug group recorded a value of −0.05 and the placebo group −0.74. For the brain electrical activity measure (counting clusters of activity during the difficult task), the drug group recorded 44 clusters compared to 17 in the placebo group. On the secondary measures — standardised rating scales for positive symptoms (things like hallucinations) and negative symptoms (things like reduced motivation) — the reported changes were small and broadly similar between the two groups, with scores changing by around 0.58 to 2.12 points on a 0–5 scale in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01614093 · results posted 21 September 2017

According to the results reported on ClinicalTrials.gov, this trial involved 17 participants who were enrolled in a single group that received both oxytocin and a placebo (a dummy treatment with no active ingredient) at different times. This type of design, where the same people try both treatments, is sometimes called a crossover study. The trial was measuring how much food participants ate from a test meal served 90 minutes after receiving either oxytocin or the placebo, with the idea being to see whether oxytocin had any connection to feelings of fullness. Sixteen of the 17 participants completed the study, with one person not finishing. The reported data shows that food consumption — measured in grams — was 7.9 grams in one condition and 7.4 grams in the other condition. The data submitted to ClinicalTrials.gov does not clearly label which of these two numbers corresponds to the oxytocin period and which corresponds to the placebo period, so it is not possible to say from the available data how the two conditions compared to each other. No other outcome measures were reported in the submitted results. It is also worth noting that these are very small gram amounts for a meal, and the submission does not provide further context to explain this figure. Any additional detail about what these numbers mean in a broader sense was not reported in the data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01895452 · results posted 25 August 2017

According to the results reported on ClinicalTrials.gov, this trial looked at a medication called ALKS 9072 in two groups: a lower-dose group (65 people) and a higher-dose group (226 people), giving a total of 291 participants. The trial was measuring how often participants experienced side effects or unwanted events during treatment, as well as tracking any changes in their symptoms over time using two standard rating scales — one focused on schizophrenia symptoms (called the PANSS) and one where a clinician rates how unwell the person appears overall (called the CGI-S). The reported data shows that 21 out of 65 people in the low-dose group, and 94 out of 226 people in the high-dose group, experienced a treatment-emergent adverse event — meaning an unwanted event that occurred during the treatment period. On the PANSS symptom scale (which runs from 30 to 210, where lower scores mean fewer symptoms), the reported data shows an average change from the starting point of minus 0.7 points in the low-dose group and minus 0.9 points in the high-dose group by the end of the treatment period. On the CGI-S clinician rating scale (which runs from 1 to 7, where lower numbers mean less unwell), both groups showed an average change of minus 0.1 points from their starting score. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00628589 · results posted 29 June 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 344 people across three groups: 115 received an inhaled placebo (an inactive substance with no medicine), 116 received a 5 mg dose of inhaled loxapine, and 113 received a 10 mg dose of inhaled loxapine. The trial was measuring agitation in people with certain mental health conditions, using a scoring tool called the PANSS-EC — a scale made up of five items (such as tension, hostility, and excitement), where higher scores indicate more severe agitation. Participants needed a minimum score of 14 out of 35 to be included. The main thing being tracked was how much participants' scores changed over the course of the study. The reported data shows that, on the primary measure, average PANSS-EC scores dropped by 5.5 points in the placebo group, by 8.1 points in the 5 mg loxapine group, and by 8.6 points in the 10 mg loxapine group (lower scores meaning less agitation on this scale). A secondary measure called the CGI-I — where a clinician rates overall change on a scale of 1 ("very much improved") to 7 ("very much worse") — showed average scores of 2.8 for the placebo group, 2.3 for the 5 mg group, and 2.1 for the 10 mg group at two hours after the dose was given. The reported data also shows that 41 out of 115 placebo participants, 66 out of 116 participants in the 5 mg group, and 75 out of 113 participants in the 10 mg group scored 1 or 2 on the CGI-I at two hours — meaning a clinician rated them as "very much improved" or "much improved" at that point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02614586 · results posted 1 May 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02614586) enrolled 11 participants in a screening phase, and all 11 completed that phase with none dropping out. The trial was designed to look at how a drug called TAK-058 might affect a brain response measurement called the "P50 ratio" — a way of measuring how the brain filters out repeated sounds. It was also intended to track how many participants experienced any unwanted side effects after taking the study treatments (TAK-058 and ondansetron). The reported data shows that no results were submitted for either the primary outcome (the P50 brain response measurement) or the secondary outcome (the proportion of participants who experienced side effects). Both of these outcome measures are listed in the trial record under a second phase of the study — "Part 2: TAK-058 and Ondansetron" — but no numbers were reported for that part. Based on what was submitted, it appears the trial did not progress beyond the initial screening phase, and the data for these outcomes was not reported. Because no results figures were provided for either outcome measure, it is not possible to describe what the trial found in terms of the brain response measurements or side effects. The reported data shows only that 11 people were screened and completed that screening step. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02462473 · results posted 29 March 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02462473) enrolled 9 people, all placed in a single group. The study was looking at people with schizophrenia and was measuring whether having access to blood-level readings of antipsychotic medication influenced the decisions doctors made about treatment — for example, changing medications, adjusting psychosocial (non-medication) support, or altering how often patients came in for visits. The trial was ended early, and only 5 of the 9 participants completed it. The reported data shows that out of the 9 participants, 4 had what the study called a "medication treatment modification" — meaning their treatment was changed at some point during the trial. For the secondary measures, because the study ended early, individual scores rather than group summaries were reported. Scores on the clinical severity rating (a 7-point scale where 1 means "not ill" and 7 means "extremely severe") ranged from 3 to 5 across participants at the two time points measured. Scores on a symptom severity scale (ranging 0–32, with higher meaning more severe) ranged from 2 to 14. Blood levels of antipsychotic medication varied widely across participants, from 7.72 to 660 nanograms per millilitre. Adherence scores (how well participants were following their treatment, rated 1–7 by their clinician) were reported as 7 — the highest possible score — for all participants at both time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00983476 · results posted 13 February 2017

According to the results reported on ClinicalTrials.gov, a total of 276 people took part in this trial — 95 in an in-person weight management programme (called MOVE! SMI), 93 in a web-based version of the same programme, and 88 in a usual care group that received information handouts only. The trial was measuring body weight (using a calculation called BMI, which compares a person's weight to their height), as well as people's confidence in making healthy eating choices and their quality of life, all assessed at a six-month follow-up point. The reported data shows that at six months, average BMI scores were 34.9 for the in-person group, 33.4 for the web-based group, and 34.4 for the usual care group. When looking only at participants who were classified as obese (BMI above 30), the reported figures were 35.9, 34.2, and 35.6 respectively. On a confidence scale of 1 to 5 (where higher means more confident), the reported data shows scores for confidence in cutting calories were 4.1, 3.9, and 4.0 across the three groups, and scores for confidence in reducing fat in the diet were 4.1, 3.9, and 3.8. For the secondary outcomes, the reported data shows that quality of life scores related to physical functioning were 2.4, 2.4, and 2.6 across the three groups (on a 1–5 scale where lower scores indicate greater difficulty), and scores related to self-esteem were 2.3, 2.3, and 2.5. These scores were similar across all three groups at the time of measurement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00826202 · results posted 8 February 2017

According to the results reported on ClinicalTrials.gov, this trial looked at a substance called D-Serine compared to a placebo (a dummy treatment with no active ingredient) in people who were showing early warning signs that might be linked to psychosis — sometimes called a "prodromal" state. A total of 44 people started the trial (20 in the D-Serine group and 24 in the placebo group). However, only 21 people fully completed the trial (10 in the D-Serine group and 11 in the placebo group). The main thing the trial was measuring was a set of symptoms called "negative symptoms" — things like reduced motivation, low energy, or withdrawal from others — using a standardised rating tool called the Scale of Prodromal Symptoms (SOPS), where higher scores mean more severe symptoms. The reported data shows that at the end of the trial, the D-Serine group had an average negative symptom score of 7.6 out of a possible 36, while the placebo group had an average score of 11.3. For the overall SOPS total score (which covers a broader range of symptoms and runs from 0 to 114), the D-Serine group averaged 23.9 and the placebo group averaged 30.5. The trial also measured sleep quality using a standard questionnaire scored from 0 to 21 (where higher scores indicate poorer sleep) — the D-Serine group recorded an average of 4.0 and the placebo group 7.7. Additionally, levels of a biological marker in the blood called IL-6 were measured; the D-Serine group averaged 0.49 pg/ml and the placebo group 0.79 pg/ml. It is important to note that these are end-point scores only — the reported data does not include information about whether these differences between groups were considered statistically meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00517075 · results posted 13 January 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT00517075) investigated a brain stimulation technique called repetitive Transcranial Magnetic Stimulation (rTMS) — a non-invasive procedure that uses magnetic pulses to stimulate areas of the brain. The study involved four groups: two groups receiving high-frequency rTMS, one group receiving a sham (placebo/fake) version of the treatment, and one group that crossed over to receive active rTMS after an initial phase. However, the reported data shows that the number of participants recorded as starting, completing, or not completing the study was listed as zero for every group, meaning the participant numbers were not meaningfully reported in the submitted data. The reported data shows that the trial set out to measure several things: the primary measure was whether participants' negative symptoms of a mental health condition improved (using a standard rating scale called the PANSS Negative Symptoms Subscale — a tool used to score certain symptoms). Secondary measures included overall clinical improvement, social functioning, depression, a social thinking skill called "theory of mind," and smoking behaviours. However, for every one of these outcome measures — both primary and secondary — no numerical results were included in the data submitted to ClinicalTrials.gov. The measurements fields are entirely empty across all groups. In plain terms, while the trial had a clear plan for what it wanted to measure across multiple groups, the structured results as submitted contain no actual numbers for either participant counts or any of the outcomes being tracked. This means it is not possible to describe what the trial found from this data alone, as the figures were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01953237 · results posted 19 December 2016

According to the results reported on ClinicalTrials.gov, this trial involved 31 people in total — 10 in a control group and 21 in a group referred to as "MedActive." All 31 participants completed the study with no dropouts. The trial was measuring how consistently participants took their antipsychotic medications (medicines used to manage certain mental health conditions) as prescribed, based on what participants reported themselves. The reported data shows that the primary outcome measured was the percentage of days on which participants said they took their medications as prescribed. The control group reported taking their medications on approximately 92.6% of days, while the MedActive group reported doing so on approximately 93.4% of days. No other outcome measures were included in the data submitted to ClinicalTrials.gov, so no further figures can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01879722 · results posted 28 October 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01879722) enrolled 77 participants across ten groups: people with schizophrenia who received one of five doses of an investigational drug called TAK-063 (3 mg, 10 mg, 20 mg, 30 mg, or 100 mg) or a placebo, and healthy volunteers who received one of three doses (3 mg, 10 mg, or 20 mg) or a placebo. Group sizes ranged from 6 to 9 people. The trial was measuring various physical and laboratory readings after 7 days of dosing — including how often participants experienced any unexpected medical event (called a treatment-emergent adverse event, or TEAE), whether blood and urine tests came back markedly outside normal ranges, whether vital signs such as blood pressure and pulse were markedly abnormal, and whether heart tracing (ECG) results were markedly abnormal. The trial also tracked how the drug moved through the body — for example, the highest level it reached in the blood and how long that took. The reported data shows that the percentage of participants who experienced at least one TEAE ranged from around 57% to 100% across the TAK-063 dose groups, and was about 56% in the schizophrenia placebo group and 50% in the healthy volunteer placebo group. For markedly abnormal laboratory test results, the reported figure was 0% across nearly all groups, with the exception of the healthy volunteer group receiving 3 mg, where 25% were reported as having a markedly abnormal result. For vital signs, the reported data shows that 100% of participants in almost every group — including placebo groups — met the criteria for a markedly abnormal vital sign reading at some point, with the only exception being the lowest-dose schizophrenia group at 71.4%. For heart tracings (ECGs), the percentage of participants with markedly abnormal readings ranged from around 33% to 75% across all groups, including placebo groups. On how the drug moved through the body, the reported peak blood concentration of TAK-063 increased with higher doses, ranging from about 15 ng/mL at 3 mg to about 211 ng/mL at 100 mg in schizophrenia participants, and from about 15 ng/mL to about 116 ng/mL across the healthy volunteer doses. The time to reach that peak concentration was generally reported as between 2 and 4 hours across groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00793780 · results posted 6 October 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people in total — 12 in each group. Participants were randomly assigned to receive either naltrexone (25mg) or a placebo (a dummy pill with no active ingredient). The trial was measuring a number of things, most importantly any change in body weight, but also blood sugar levels, insulin levels, cholesterol, symptom severity (using a standard rating scale for schizophrenia called the PANSS), and cravings for sweet or rich foods. The reported data shows that, on average, the group taking naltrexone 25mg had a change in body weight of minus 3.40 kg from the start of the trial, while the placebo group had an average change of plus 1.37 kg. For blood sugar (fasting glucose), the reported data shows two sets of figures for each group — suggesting measurements were taken at more than one point in time — with the naltrexone group recording 113.40 and then 129.22 mg/dL, compared to 93.82 and 94.11 mg/dL for the placebo group. Insulin levels followed a similar pattern, with the naltrexone group recording 26.42 and then 35.51 microIU/mL versus 13.84 and 12.36 microIU/mL for the placebo group. For LDL cholesterol (a type of cholesterol measured in the blood), the naltrexone group recorded 86.80 and then 104.11 mg/dL, compared to 123.18 and then 111.22 mg/dL in the placebo group. On the PANSS symptom scale (which runs from 30 to 210, where a higher number means more severe symptoms), average scores were 57.50 for the naltrexone group and 52.63 for the placebo group. For the food craving questionnaire (scored 9 to 63, where higher means stronger cravings), the naltrexone group reported an average change of minus 3.10 points, while the placebo group reported no change (0). Ten out of 12 people completed the naltrexone arm, and 11 out of 12 completed the placebo arm. It is worth noting that this was a small trial with only 12 people per group, and the figures above are simply the numbers submitted by the study team. The reported data does not allow conclusions to be drawn about whether any of these differences are meaningful beyond this small group of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00531518 · results posted 15 August 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT00531518) involved two groups of people considered to be at risk of developing psychosis. A total of 87 people were in the Control Group and 205 people were in the Family-aided Assertive Community Treatment (FACT) group — 292 participants in all. Of those, 55 in the Control Group and 134 in the FACT group completed the study. The trial was measuring psychotic symptoms using a tool called the Scale of Prodromal Symptoms (SOPS), which scores certain symptoms on a scale from 0 to 30, where 0 means no psychotic symptoms and 30 means the most severe level of psychotic symptoms measured by the scale. The reported data shows that, at the end of the study period, the Control Group had an average positive symptom score of 9.2 out of 30, while the Family-aided Assertive Community Treatment group had an average score of 6.7 out of 30. These numbers represent the average sum of five symptom items, each rated from 0 to 6. No other outcome measures were included in the data reported to ClinicalTrials.gov, so further details about secondary outcomes or other symptom areas were not reported in the structured results available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02332798 · results posted 14 June 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 39 people across three groups: 13 received a lower dose of the study drug PF-04958242 (0.25 mg), 14 received a higher dose (0.475 mg), and 12 received a placebo (a dummy treatment with no active ingredient). Most participants completed the study — 12, 12, and 11 people respectively from each group. The trial was primarily measuring how the drug moved through the body — specifically, how much of it got into the bloodstream and how quickly — rather than measuring a medical symptom or condition. The reported data shows the following blood-level measurements for the two active dose groups. For the peak level of drug in the blood (the highest concentration reached after a dose), the lower-dose group reached 1.920 nanograms per millilitre (ng/mL) after a single dose, rising to 3.174 ng/mL after 14 days of regular dosing; the higher-dose group reached 3.830 ng/mL after a single dose and 7.139 ng/mL at day 14. The time it took to reach that peak was reported as approximately 1.65 hours for the lower-dose group and 1.33 hours for the higher-dose group, both after a single dose and at steady state. The total amount of drug in the blood over a 12-hour dosing period was also measured: after a single dose this was 9.570 ng·h/mL (lower dose) and 17.72 ng·h/mL (higher dose), increasing to 24.57 and 50.09 ng·h/mL respectively after 14 days. No blood-level measurements were reported for the placebo group, as these measures only apply to an active drug. The reported data covers only how the drug behaved in the bloodstream; no outcome figures relating to any medical condition or symptom were included in this submission. The placebo group's results were not reported for these blood-level measures, as that group received no active compound. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01515423 · results posted 2 May 2016

According to the results reported on ClinicalTrials.gov, this trial looked at two different formulations of an injectable medication called paliperidone palmitate — one version given every month (PP1M) and one given every three months (PP3M) — in adults with schizophrenia. The trial ran in two stages: an open-label phase, where 1,429 participants all received the monthly injection, followed by a double-blind phase (where neither participants nor doctors knew which version was being given), in which 1,016 participants who completed the first stage were split into two groups — 504 received the three-monthly injection and 512 continued with the monthly injection. The main thing being measured was how many people in each group went 48 weeks without experiencing a "relapse" — a significant worsening of their condition as defined by specific criteria including hospitalisation, certain changes in symptom scores, or serious safety events. The reported data shows that, at the end of the 48-week double-blind phase, 91.5% of participants in the three-monthly injection group and 90.0% in the monthly injection group were recorded as not having had a relapse by that point. For the secondary measures, the reported data shows that scores on a standard symptom scale (PANSS, rated 30–210 where higher means more severe symptoms) changed by an average of −3.5 points in the three-monthly group and −4.3 points in the monthly group from the start of the double-blind phase. Scores on a clinician-rated illness severity scale (CGI-S, rated 1–7) changed by −0.1 points in both groups. A scale measuring personal and social functioning (PSP, rated 1–100 where higher is better) changed by +1.3 points in the three-monthly group and +1.9 points in the monthly group. Around 58.4% of the three-monthly group and 59.2% of the monthly group met the criteria for what researchers defined as symptomatic remission during the last six months of the double-blind phase. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01810380 · results posted 29 March 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01810380) enrolled 468 adults with schizophrenia across three groups: 163 received a placebo (a dummy treatment with no active ingredient), 151 received brexpiprazole, and 154 received quetiapine extended release. The trial ran for 6 weeks and was primarily measuring changes in schizophrenia symptom severity using a structured rating tool called the PANSS (Positive and Negative Syndrome Scale), which scores symptoms on a scale from 30 to 210 — a higher number means more severe symptoms. By the end of the trial, 108 placebo participants, 113 brexpiprazole participants, and 122 quetiapine extended release participants had completed the study. The reported data shows that, on average, PANSS total scores fell (improved) in all three groups over the 6 weeks. The placebo group's score dropped by 15.9 points, the brexpiprazole group's by 20.0 points, and the quetiapine extended release group's by 24.0 points. Clinicians also rated overall illness severity (on a 7-point scale where lower is less severe) and overall impression of change (on a 7-point scale where lower means more improved). For illness severity, the reported average drops were 0.9 points for placebo, 1.2 for brexpiprazole, and 1.4 for quetiapine extended release. For the improvement rating at week 6, scores were 3.0 (placebo), 2.7 (brexpiprazole), and 2.5 (quetiapine extended release) — all sitting near the middle of that scale. The reported data also shows changes in three sub-sections of the PANSS scale — positive symptoms (things like hallucinations and delusions), negative symptoms (things like emotional withdrawal), and general symptoms. Across all three sub-sections, score reductions were reported in every group, with the quetiapine extended release group showing the largest average reductions and the placebo group showing the smallest. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01377233 · results posted 22 March 2016

According to the results reported on ClinicalTrials.gov, this trial involved 46 participants in total. The trial was studying a medicine called zicronapine, which was being tested in two stages. First, all 46 participants took a daily 10 mg dose for about three weeks (the open-label stage, where everyone knew what they were taking). Forty-two of those 46 people completed this stage. The 42 who finished were then randomly assigned to one of four groups for a five-week double-blind stage (where neither participants nor researchers knew which dose each person was receiving): a continuing daily 10 mg dose, or one of three once-weekly doses — 20 mg, 30 mg, or 45 mg. The trial's main focus was recording how many participants in each group experienced unwanted side effects, as a way of examining tolerability. The reported data shows that, during the open-label stage, 12 out of 46 participants experienced at least one unwanted side effect. In the double-blind stage, the number of participants who experienced side effects in each group was: 8 out of 11 in the daily 10 mg group, 4 out of 10 in the 20 mg weekly group, 4 out of 11 in the 30 mg weekly group, and 9 out of 10 in the 45 mg weekly group. The trial also measured participants' symptoms using two standard rating tools. On the PANSS scale (a 30-item symptom checklist scored from 30 to 210, where lower numbers mean fewer symptoms), all four double-blind groups showed a reduction in total score from where they started, ranging from −8.0 to −12.2 points. On the CGI-S scale (a 7-point clinician rating of illness severity, where lower is better), scores also decreased slightly across all groups, ranging from −0.2 to −0.7 points. On the CGI-I scale (a 7-point rating of overall change, where 1 means very much improved and 4 means no change), average scores across the four groups ranged from 2.9 to 3.4, sitting broadly around the "minimally improved" to "no change" range. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00594256 · results posted 8 February 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 8 participants, all of whom completed the study — none dropped out. The trial was looking at the effects of sodium oxybate (a medication taken by mouth) on sleep quality and daytime sleepiness in people with schizophrenia, as well as some secondary measures including symptoms of schizophrenia, thinking and memory abilities, and the amount of deep ("slow wave") sleep recorded overnight. The reported data shows that at the end of the trial, participants had an average score of 6.1 out of 21 on the Pittsburgh Sleep Quality Index (a questionnaire where higher numbers mean more sleep difficulties, and scores above 5 are generally considered to indicate poor sleep). On the Epworth Sleepiness Scale (a questionnaire measuring daytime sleepiness out of 24, where scores above 10 suggest significant sleepiness), the average score was 4.8. For the secondary measures, the reported data shows an average decrease of 2.8 points on a scale measuring certain schizophrenia symptoms (rated 7–49, where lower is better), a very small change of −0.26 on a composite score of thinking and memory tests, and an average of 34.1 minutes of slow wave (deep) sleep recorded during overnight sleep studies. It is worth noting that because only 8 people took part, this was a very small study, and the results should be interpreted with that in mind. The reported data does not include comparison figures from before the trial began for all measures, so it is not possible from this data alone to describe the full picture of change over time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01854944 · results posted 4 February 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01854944) enrolled 12 people in total, split across three small groups of four participants each. Two groups received a 4 mg daily dose of a medicine called brexpiprazole, and one group received a 1 mg daily dose. The trial was measuring how much brexpiprazole "occupied" (attached to) certain chemical receptors in the brain — specifically dopamine receptors (D2/D3), serotonin receptors (5-HT1A and 5-HT2A), and a serotonin transporter (SERT). Brain scans using special radioactive tracers were done before and after 10 days of treatment to compare the binding at these receptors. The trial also tracked how much of the medicine was present in participants' blood over time. Eleven of the 12 participants completed the study; one person in the second 4 mg group did not finish. The reported data shows the following receptor occupancy figures (expressed as a percentage — meaning the share of receptors that brexpiprazole appeared to be attached to) measured four hours after the last dose on Day 10. For dopamine D2/D3 receptors, the 1 mg group showed an average occupancy of around 36%, while the 4 mg group showed around 59%. For serotonin 5-HT2A receptors, the 1 mg group showed approximately 28% occupancy and the 4 mg group approximately 45%. For the 5-HT1A serotonin receptor (measured only in the 4 mg groups), the reported average occupancy was about 4%. For the serotonin transporter (SERT, also measured only in the 4 mg groups), the reported figure was -3%, meaning no meaningful occupancy was detected at that site. Regarding blood levels of the medicine, the reported data shows that higher doses were associated with higher concentrations in the blood, though the two 4 mg groups produced somewhat different blood level readings, which the trial investigators did not explain further in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01487668 · results posted 22 January 2016

According to the results reported on ClinicalTrials.gov, this trial involved 287 participants split into two groups: 146 people received usual care, and 141 people took part in a programme called "Life Goals Collaborative Care." The trial was measuring quality of life — specifically, how people rated their physical and mental health and wellbeing — using a standard survey tool called the VR-12 (Veterans Short Form 12-item survey). This survey produces scores from 0 to 100, where a higher score means a person reported better quality of life. Scores were tracked over 12 months. By the end of the study, 121 people in the usual care group and 124 people in the Life Goals group had completed the trial. The reported data shows that for physical health-related quality of life, the usual care group scored an average of 34.00 and the Life Goals group scored an average of 33.61 out of 100. For mental health-related quality of life, the usual care group scored an average of 36.36 and the Life Goals group scored an average of 38.13 out of 100. These are the average scores recorded at the end of the 12-month period. It is worth noting that the data as submitted does not include the starting (baseline) scores for comparison, so the reported data shows only these final average figures rather than the full picture of change over time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01795547 · results posted 3 December 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01795547) enrolled 295 people with schizophrenia or a related condition, split into two groups: 148 people took aripiprazole and 147 took paliperidone. The trial ran for 28 weeks and was mainly measuring changes in quality of life and day-to-day functioning using a clinician-rated questionnaire called the Quality of Life Scale (QLS). Higher scores on the QLS mean better functioning. By the end of the trial, 100 people in the aripiprazole group and 83 in the paliperidone group had completed the full 28 weeks. The reported data shows that, for the main outcome — change in QLS total score from the start to week 28 — the aripiprazole group had an average increase of 7.47 points (out of a possible 126), while the paliperidone group had an average increase of 2.80 points. For the secondary outcomes, a clinician's overall rating of illness severity (the CGI-S, scored 1–7) showed an average decrease of 0.75 points in the aripiprazole group and 0.46 points in the paliperidone group — where a decrease means the clinician rated the illness as less severe. On a separate questionnaire where clinicians compared the study medication to each participant's previous medication (the IAQ, scored 12–60, where lower scores mean the current medication was rated better), the aripiprazole group averaged 32.32 and the paliperidone group averaged 33.81. The reported data also shows changes within the individual QLS sub-sections (covering interpersonal relations, intrapsychic foundations, and common objects and activities), all of which showed increases in both groups, with the aripiprazole group reporting larger increases in each sub-section. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01909466 · results posted 2 June 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01909466) enrolled 141 adults in total across two groups: 68 people received injections into the gluteal muscle (buttock) first and then the deltoid muscle (upper arm), while 73 received both injections into the deltoid muscle. The trial was testing a long-acting injectable form of aripiprazole (a medication used for certain mental health conditions), given as a monthly injection. The study tracked a range of things including injection site pain, unwanted side effects, and changes in movement-related symptoms and suicidal thoughts over the course of the trial. Of the 141 who started, 96 completed the study. The reported data shows that out of the total group of participants treated, 112 experienced at least one adverse event (an unwanted medical occurrence during the trial), and 4 experienced a serious adverse event (one that was life-threatening, caused hospitalisation, or resulted in death). Two participants were reported to have discontinued due to an adverse event. For injection site pain, participants rated their pain on a scale from 0 to 100 (called a Visual Analog Scale), and the reported average score was 2.0 before injection and 1.2 after injection — both very low on the scale. Changes in movement-related symptoms (measured by three standard rating tools) were reported as very small numbers, close to zero, across all time points measured during the study. Similarly, the reported data shows that changes in suicidal thought intensity scores, measured on a scale of 0 to 25, were also very close to zero throughout the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00137267 · results posted 29 April 2015

According to the results reported on ClinicalTrials.gov, this trial involved 102 participants in total — 55 in a group called "Time Limited Case Management" and 47 in a group called "Health Education." The trial was measuring how engaged participants were with treatment over an 8-week period, specifically looking at how many treatment sessions they attended and how many days they stayed connected with the program. The reported data shows that, for the primary measure of treatment engagement, the Time Limited Case Management group attended an average of 4.2 and 7.2 treatment sessions (two separate measurements were reported for this group), while the Health Education group attended an average of 1.4 and 1.5 sessions across the same measurements. For the secondary measure, the Time Limited Case Management group was reported to have been involved with the program for an average of 37.3 days from first consent to last contact, compared to 28.9 days for the Health Education group. It is worth noting that a notable number of participants did not complete the study — 15 from the first group and 21 from the second. Of the 102 people who started the trial, 66 completed it (40 from the Time Limited Case Management group and 26 from the Health Education group). No further outcome data beyond what is described above was reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00158223 · results posted 9 April 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 53 people in total — 28 in the placebo group (a dummy treatment with no active ingredient) and 25 in the pimozide group. Of those, 23 and 22 people respectively completed the study. The trial was measuring changes in symptoms associated with schizophrenia, using two main rating scales: one focused on "positive" symptoms (such as hallucinations and delusions) and one focused on "negative" symptoms (such as emotional withdrawal and apathy). A secondary measure asked clinicians to rate their overall impression of how each participant had changed over the course of the trial. The reported data shows the following changes in scores from the start to the end of the trial. On the positive symptoms scale (where lower scores mean less severe symptoms), the placebo group's average score changed by −1.05 points and the pimozide group's changed by −1.30 points — both small decreases on a scale that runs from 7 to 49. On the negative symptoms scale, the placebo group's average score changed by −1.59 points (a small decrease), while the pimozide group's average score changed by +0.65 points (a small increase). For the clinician's overall impression of change — rated on a 7-point scale where lower numbers indicate more improvement — the placebo group's average score changed by −0.35 and the pimozide group's by −0.15. These numbers represent average changes across the group and do not tell us about any individual person's experience. No further breakdown of the results was reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00237796 · results posted 6 April 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 79 people in total — 41 in a programme called Cognitive Behavioural Social Skills Training (CBSST), which combines talk-based therapy with practical skills practice, and 38 in a comparison programme called Goal Focused Supportive Contact (GFSC), a structured supportive conversation approach. By the end of the study, 31 people in the CBSST group and 33 in the GFSC group had completed the trial. The trial was measuring everyday functioning, skills learnt in the programmes, and various symptoms including depression and positive and negative symptoms associated with serious mental illness. The reported data shows that for the main measure — everyday functioning scored on a scale of 0 to 1 (where higher means better functioning) — both groups started at similar levels (around 0.66–0.70) and showed broadly similar scores across all measurement points, ending at roughly 0.71 for the CBSST group and 0.68 for the GFSC group. For the skills test specific to the CBSST programme (scored 0–33), the CBSST group's scores rose from around 6.2 at the start to around 11.2 by the final time point, while the GFSC group's scores went from 4.8 to around 5.8. The reported data also shows scores on measures of depression, and positive and negative symptoms, tracked across multiple time points for both groups, with figures shifting modestly in both directions across the study — for example, depression scores (0–63 scale) moved from roughly 16 in both groups at the start, to about 9.1 (CBSST) and 12.9 (GFSC) at the last reported point. Scores for symptom measures were not reported for all time points consistently across all measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01149655 · results posted 2 April 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 186 people who were already taking a different antipsychotic medication and were switched to a medicine called aripiprazole. The trial ran in three stages: a conversion stage (switching to aripiprazole), a stabilisation stage (getting settled on the medication), and finally a double-blind maintenance stage where participants were randomly assigned — without knowing which they received — to either continue aripiprazole (98 people) or switch to a dummy pill called a placebo (48 people). The main thing the trial was measuring was how many people in each group experienced a return or worsening of psychotic symptoms (called a "relapse") during the maintenance stage. The reported data shows that, for the primary outcome — the overall relapse rate — approximately 19% of participants in the aripiprazole group met the criteria for relapse, compared with approximately 38% in the placebo group. For the secondary outcomes, the reported data shows that around 16% of the aripiprazole group and 33% of the placebo group met the specific criteria for an impending relapse. Roughly 44% of the aripiprazole group and 42% of the placebo group were reported to have achieved a period of remission (meaning their symptoms were at a low level for six months). Approximately 26% of the aripiprazole group and 48% of the placebo group discontinued the trial for reasons other than the sponsor ending the study. The reported data also shows small average changes in a standard symptom rating scale (where higher scores mean worse symptoms), but the specific figures varied across different time points in the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00357006 · results posted 1 April 2015

According to the results reported on ClinicalTrials.gov, this trial involved 180 women in total — 62 received a 200 microgram estradiol skin patch, 56 received a 100 microgram estradiol skin patch, and 62 received a placebo (an inactive patch). The trial was measuring changes in psychiatric symptoms in women who were already receiving treatment for a condition involving psychosis (such as schizophrenia). The main tool used to measure symptoms was called the PANSS (Positive and Negative Syndrome Scale), which rates symptoms like hallucinations, delusions, and difficulties with thinking and emotion on a numbered scale — higher numbers mean more severe symptoms. The reported data shows that at the start of the trial, the average PANSS scores across all three groups were similar: approximately 18.2 for the 200 microgram group, 19.2 for the 100 microgram group, and 18.2 for the placebo group. By the end of the trial, the reported scores had changed to approximately 14.1 for the 200 microgram group, 16.4 for the 100 microgram group, and 16.4 for the placebo group. The reported data shows that all three groups had lower scores at the end of the trial compared to the beginning, meaning symptoms appeared less severe across all groups by the time the trial concluded. For the secondary outcome measures — which included cognitive performance, mood scores, side effect reports, and hormone level changes — the results data was not reported on ClinicalTrials.gov, so no numbers are available for those areas. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01683058 · results posted 31 March 2015

According to the results reported on ClinicalTrials.gov, this trial involved 74 people who received injections of a long-acting, injectable form of aripiprazole (a medication used for certain mental health conditions), given as a depot injection into the muscle. Of the 74 participants who started the trial, 45 completed it and 29 did not finish. The trial was primarily measuring how often participants experienced unwanted medical events (called adverse events) after receiving the injections, and also tracked a range of other measures including movement-related side effects, suicidal thoughts, and body temperature. The reported data shows that 66.2% of participants experienced at least one treatment-emergent adverse event — meaning an unwanted medical event that occurred after starting the injections. Of those, 6.8% experienced a severe adverse event, 8.1% stopped taking the medication due to an adverse event, and 8.1% experienced a serious adverse event. No deaths were reported (0.0%). For the secondary measures, the reported data shows small average changes from the starting point across the various scales used to track movement side effects (such as muscle stiffness, tremor, and restlessness), suicidal thoughts, and body temperature. The numbers reported were generally small — for example, average changes in movement-related scores ranged from around -0.1 to +0.2 on their respective scales, and average body temperature changes were at or very close to zero degrees Celsius across measurement points. It is important to note that these figures describe what was observed and measured in this particular group of trial participants only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01432444 · results posted 27 March 2015

According to the results reported on ClinicalTrials.gov, this trial looked at aripiprazole given as a long-acting injectable (a monthly injection rather than a daily pill) for people with schizophrenia. The study ran in three stages: a short cross-over/settling-in phase (Phase A), a main open-label treatment phase (Phase B), and an extension phase (Phase C). A total of 325 people entered Phase A, 433 entered the main treatment phase (Phase B), and 192 entered the extension phase. The main question the trial was designed to answer was whether the rate of psychiatric hospital admissions changed when participants switched from their usual oral antipsychotic medication to the injectable form over a comparable six-month window. The reported data shows that for the primary outcome — comparing hospital admissions in the six months before the switch versus six months after — 91 participants were recorded in one category and 9 in another for the 336-person group who completed at least three months of Phase B treatment. The data as submitted does not provide labels clearly distinguishing which number represents "had a hospitalisation" versus "did not," so the breakdown cannot be described in more precise plain-English terms without risking misrepresentation. For the secondary outcomes, scores on the PANSS symptom rating scale (which runs from 30 to 210, where higher means more severe) showed reported changes from starting scores of around −7.9 to −8.4 points across different time points during treatment. Sub-scores for positive symptoms (things like hallucinations and delusions) changed by roughly −2.7 to −3.0 points, and negative symptoms (such as emotional withdrawal) by about −1.6 to −1.7 points. A clinician-rated severity scale (CGI-S, scored 1–7) showed reported changes of −0.3 to −0.5, and a separate clinician-rated improvement scale (CGI-I, also 1–7, where lower means more improved) returned average scores of around 2.5 to 2.9 at various time points during Phase B. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01485640 · results posted 11 March 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01485640) involved 162 people who were given a medication called lurasidone. The study was designed to look at safety-related events over time — specifically, any unwanted side effects (called adverse events), serious adverse events, and whether people stopped taking the medication because of those events. A secondary measurement tracked how participants' overall illness severity was rated by a clinician using a standard scale called the CGI-S, which runs from 1 (not at all ill) to 7 (among the most extremely ill). Of the 162 people who started the study, 40 completed it, while 122 did not complete it. The reported data shows that, out of 162 participants, 63 experienced what are described as "treatment emergent" adverse events — that is, unwanted effects that appeared during the time they were taking the medication. Seven participants experienced a "serious" adverse event (a more significant health concern that met a specific medical definition), and 10 people stopped taking the medication because of an adverse event. For the secondary measure, the reported data shows an average change of −0.18 points on the CGI-S illness severity scale from the start of the study to 18 months. Because this scale runs from 1 to 7, a change of −0.18 represents a very small shift in the downward direction (toward lower severity). It is worth noting that the data as submitted includes some formatting that makes it unclear whether the three adverse event numbers (63, 7, and 10) are reported as entirely separate figures or overlap in some way, and the submission does not break them down further. No additional outcome data beyond these figures was reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00144027 · results posted 23 December 2014

According to the results reported on ClinicalTrials.gov, this trial involved 75 people in total — 39 in a control group (who received no special intervention) and 36 in a group that received an antipsychotic medication adherence intervention. The trial was measuring how consistently participants took their antipsychotic medication (medication prescribed for mental, emotional, or nervous conditions). Not everyone finished the study: 36 people in the control group and 25 people in the intervention group completed it through to the end. The reported data shows that the primary outcome — medication adherence — was measured by asking participants how often they had taken their medication over the past four weeks (or past six months for those on depot injections, which are slow-release injections given by a health professional). Participants chose from a five-point scale, and "full adherence" was defined as reporting they never missed a dose. According to the results reported on ClinicalTrials.gov, 63.9% of participants in the control group reported never missing their medication, compared with 75.0% of participants in the intervention group. No secondary outcome measure data appears to have been reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01139125 · results posted 20 November 2014

According to the results reported on ClinicalTrials.gov, this trial looked at a medication called Cystagon (cysteamine bitartrate) in people with schizophrenia. There was only one group in the study — everyone received the same medication. The trial aimed to measure whether this medication might be appropriate for use in people with schizophrenia, looking at both how well it was tolerated and how it performed. The reported data shows that 3 people started the trial, 2 people completed it, and 1 person did not finish. For the primary outcome measure — which was described as assessing the safety and appropriateness of the medication for people with schizophrenia — no actual results or numbers were reported in the data submitted to ClinicalTrials.gov. This means the specific findings for that outcome measure are not available from this record. Because of the very small number of participants and the absence of reported outcome data, there is very little information available from this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01566162 · results posted 20 November 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 191 adults who were given the medication lurasidone. There was no comparison group — all participants received the same treatment. The trial was measuring two main things: how the medication affected symptoms of psychosis (using established rating scales), and what kinds of unwanted side effects occurred. A total of 155 people completed the study, while 36 did not finish. The reported data shows that, on the primary symptom scale (called the PANSS, which runs from 30 to 210, where higher numbers mean more severe symptoms), the average score across participants dropped by 8.4 points from the start of the study to the end. On a second symptom measure (the CGI-S, rated from 1 to 7, where higher means more unwell), the average score dropped by 0.48 points. Regarding unwanted effects, 72 out of 191 participants experienced at least one side effect that emerged during treatment, 13 experienced a serious adverse event (meaning a more significant medical event), and 7 left the study early because of a side effect. For the secondary measures — which looked at depression symptoms, self-rated health, and daily functioning — the reported data shows small average changes from the start of the study, but it is important to note that for the self-rated health (SF-12 physical score, which runs 0–100 with higher being better) the average change was −0.45, meaning scores were slightly lower at the end. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00731549 · results posted 11 November 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,081 adults receiving aripiprazole as a monthly injectable (given into the muscle). Of those, 858 completed the study and 223 did not finish. The trial was measuring whether people who were already considered "stable" — meaning their symptoms were under control and they were living in the community — stayed that way over the course of the study while receiving this injectable form of the medication. The reported data shows that, at each check-in point throughout the study, between roughly 97% and 100% of participants who were stable at the start remained stable at their last recorded visit. For the secondary measures, the reported data shows that the percentage of participants who met the criteria for a significant worsening of symptoms (called "impending relapse") at any given time point ranged from about 0.25% to 1.52%. Around 51.7% of all participants were reported to have achieved "remission" — meaning their symptoms fell below a defined low threshold and stayed there for at least six months. Approximately 8.2% of participants experienced a first episode of significant symptom worsening at some point during the trial. The reported data also shows small changes in a standard symptom rating scale (the PANSS, where higher scores mean more severe symptoms), with average score changes ranging from about −1.7 to −3.6 points across different parts of the scale, indicating slight reductions on average. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00446992 · results posted 6 November 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people who had never previously taken antipsychotic medication. The study tracked a range of physical health measurements over time — including body weight (measured as Body Mass Index, or BMI, a number calculated from height and weight), blood sugar levels, insulin levels, a longer-term blood sugar marker called Haemoglobin A1c, an inflammation marker called IL-6, and triglycerides (a type of fat found in the blood). Of the 30 people who started the trial, 14 completed it and 16 did not. The reported data shows the following figures recorded across five time points during the study. BMI readings across those time points were 22.1, 23.5, 24.2, 24.3, and 24.6 kg/m². Fasting blood sugar (glucose) readings were 82.1, 83.2, 86.0, 85.3, and 89.1 mg/dL. Fasting insulin readings were 9.7, 12.1, 10.5, 11.1, and 10.7 mg/dL. Haemoglobin A1c percentages were 4.4, 4.4, 4.3, 4.4, and 4.3%. The inflammation marker IL-6 was recorded at 3.5, 3.9, 6.4, 3.8, and 2.3 pg/mL. Triglyceride levels were 80.1, 98.73, 107.2, 115.4, and 113.47 mg/dL. No comparison group data was reported, and the data as submitted does not specify which time points each set of numbers corresponds to. It is worth noting that just under half of the participants did not complete the trial, which the reported data does not explain further. No reasons for non-completion were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00466323 · results posted 20 October 2014

According to the results reported on ClinicalTrials.gov, this trial involved 232 participants — 117 in a group receiving something called the FMPO (Family Mental Health Program/condition) and 115 in a comparison group receiving an enhanced version of their usual treatment (called e-TAU). The trial was looking at how often clinicians made contact with veterans' family members, and also at how veterans themselves rated their own sense of recovery and wellbeing. By the end of the study, 89 people in the FMPO group and 92 in the e-TAU group had completed the trial, with 28 and 23 people respectively not completing it. The reported data shows that for family-clinician contact, the FMPO group started with an average of 0.4 interactions and ended with 1.6 interactions, while the e-TAU group started at 0.3 and ended at 0.3 interactions. When contacts specifically involving the FMPO clinician were removed from the count, the reported figures were 0.5 for the FMPO group and 0.3 for the e-TAU group at the end of the study. For the recovery rating scale (scored from 0 to 120, where higher means a more positive sense of recovery), the FMPO group reported scores of 75.6 at the start and 80.2 at the end, while the e-TAU group reported 77.0 at the start and 79.9 at the end. On one smaller part of that scale measuring "overcoming stuckness" (scored 0–16), the FMPO group went from 10.6 to 11.4, and the e-TAU group went from 11.4 to 11.3. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01552772 · results posted 9 September 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01552772) enrolled 60 people who received a 400 mg intramuscular (injected into the muscle) depot — meaning a slow-release injection — of a medicine called aripiprazole. Of the 60 who started, 56 completed the trial and 4 did not. The trial was measuring two main things: how many participants experienced adverse events (any new or worsening medical problem that occurred during the trial), and how participants' scores changed on a standard symptom rating scale called the PANSS (Positive and Negative Syndrome Scale), which is used to rate the severity of certain mental health symptoms on a scale from 30 (least severe) to 210 (most severe). The reported data shows that 35 out of 60 participants experienced at least one adverse event during the trial, and 1 participant experienced a serious adverse event (defined as a medical problem that was life-threatening, caused death, or required hospitalisation). Regarding the PANSS symptom scores, the reported data shows that participants' total scores changed from their starting point by figures ranging from approximately −2.42 to −3.82 points across different time points during the trial — a negative number meaning the score went down (towards less severe) from where it started. Similar small reductions from baseline were also reported for the two sub-sections of the PANSS: the "positive symptoms" sub-scale (such as delusions and hallucinations) showed changes ranging from about −0.78 to −1.28 points, and the "negative symptoms" sub-scale (such as emotional withdrawal) showed changes ranging from about −0.78 to −1.14 points across the various time points measured. It is important to note that this was a single-group trial with no comparison group, so these numbers simply describe what was recorded for the participants involved. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01620060 · results posted 31 July 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 105 adults who were given lurasidone oral tablets. There was one group — everyone received the same treatment. Of the 105 people who started, 90 completed the trial and 15 did not finish. The trial was measuring how lurasidone moves through the body after it is swallowed — specifically, how much of the medicine gets into the bloodstream and how high the levels in the blood rise. The reported data shows a range of measurements for how much lurasidone was absorbed into the bloodstream over time (a measure called AUC, which reflects the total amount of drug in the blood across a set period). These figures, reported in standard laboratory units, ranged from around 78 to 590 ng·h/mL across the different time points and dosing days measured. The reported data also shows peak blood level measurements (the highest point the drug reached in the blood, called Cmax) ranging from approximately 24.4 to 99.7 ng/mL across the various conditions tested. It is worth noting that the data as submitted does not include individual labels for each of these values against specific doses or time points, so a more detailed breakdown was not able to be reported here. For the secondary outcome, the reported data shows that all 105 participants were counted in the review of serious and non-serious side effects, though the specific number of people who actually experienced any side events was not broken down further in the submitted results data — only the total number monitored (105) was provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01152697 · results posted 4 June 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01152697) enrolled 30 participants, all in a single group focused on patient non-compliance with treatment. The study ran for approximately 25 weeks and measured several things: how many days participants had experienced homelessness, how well they were taking their medications, and their attitudes toward medication — using a number of questionnaires and pill counts. Of the 30 people who started the trial, only 11 completed it, and 19 did not finish. The reported data shows the following numbers at the start of the study (baseline) compared to 25 weeks later. For days homeless in the previous six months, the figures were 6.50 days at baseline and 9.85 days at 25 weeks. For the proportion of medication doses taken, the reported figures were 30.91% at baseline and 10.10% at 25 weeks. On the Drug Attitude Inventory (a 0–10 scale where higher scores are considered better), scores were 7.47 at baseline and 8.07 at 25 weeks. On the Morisky Medication Rating Scale (a 0–4 scale where lower scores are considered better), scores were 2.31 at baseline and 1.19 at 25 weeks. On the Attitude Toward Medication Questionnaire (a 0–19 scale where lower scores are considered better), scores were 6.63 at baseline and 4.47 at 25 weeks. For the secondary outcome — days using health resources during months 10, 11, and 12 — the reported figures were 19.33 days at baseline and 15.50 days at the later time point. It is worth noting that only 11 of the 30 participants completed the study, which the reported data does not explain further, and no statistical analysis results (such as whether any differences were considered meaningful by the researchers) appear to have been submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00761579 · results posted 3 June 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 190 people, all of whom were taking a medication called paliperidone (an extended-release tablet) for schizophrenia. Participants had previously been switched to paliperidone from another antipsychotic medication, for one of three reasons: their previous medicine wasn't controlling their symptoms well enough (lack of efficacy), they had trouble tolerating it (lack of tolerability), or they had difficulty sticking to their medication routine (lack of compliance). Of the 190 people who started the trial, 98 completed it and 92 did not. The trial measured changes in schizophrenia symptoms and day-to-day functioning over 48 weeks using several rating scales. The reported data shows results on the main symptom scale used (called the PANSS, a 30-to-210 point scale where higher numbers mean more severe symptoms). Scores are reported as the change between the start and week 48 — a positive number here means scores were lower at week 48 than at the start. For the group previously switched due to lack of efficacy, the overall PANSS score changed by 11.57 points; for the lack-of-tolerability group, by 6.43 points; and for the lack-of-compliance group, by 16.36 points. Similar patterns were seen across the subscales measuring specific clusters of symptoms (positive symptoms, negative symptoms, and general psychopathology), with the lack-of-compliance group generally showing the largest numerical changes across all subscales. The reported data also shows results from two secondary measures. A scale assessing personal and social functioning (the PSP, scored 1–100 where higher is better) showed changes of −6.73, −2.38, and −11.36 points for the three groups respectively — noting that in this scale's calculation method, a negative change from baseline indicates scores were higher at week 48 than at the start. A questionnaire about attitudes toward medication (the DAI-10, scored −10 to +10) showed very small changes across all three groups (−0.01, −0.95, and +0.08). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01760889 · results posted 29 May 2014

**About the trial** According to the results reported on ClinicalTrials.gov, this trial (NCT01760889) compared two dose ranges of a medication called SPD489 against a placebo (an inactive treatment) in three separate groups of participants. The trial ran for 26 weeks and was designed to measure changes in symptoms commonly associated with schizophrenia, including negative symptoms (such as reduced motivation or emotional expression), social functioning, movement-related side effects, and broader symptom scales. The three groups were: SPD489 low dose range, SPD489 high dose range, and placebo. **What the numbers show** The reported data shows that the number of participants recorded as started, completed, and not completed was listed as zero for all three groups. No numerical results were reported for any of the outcome measures — including the primary measure (change in negative symptoms using the NSA-16 scale) or any of the six secondary measures (covering personal and social performance, movement scales, and overall symptom scores). In other words, the data fields for actual results were left empty in the submission to ClinicalTrials.gov, so no findings can be described from this record. **Important note** Because no participant numbers or outcome results appear to have been entered into the ClinicalTrials.gov record, it is not possible to describe what this trial found. If you are looking for results from this study, speaking with a medical professional or checking published research literature may provide more information. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01549041 · results posted 26 May 2014

According to the results reported on ClinicalTrials.gov, this trial involved 30 people in total. Twelve participants were given a single dose of asenapine (10 mg) each evening, while 18 were given two smaller doses (5 mg) spread across the day. By the end of the study, 10 people in each group had completed the full 14 days. The trial was mainly looking at how acceptable patients found their dosing schedule, and also tracked changes in psychiatric symptom scores over the two weeks. The reported data shows that patient acceptance was measured using a scale from 1 (very acceptable) to 7 (completely unacceptable). The group taking one evening dose scored an average of 1.7 on this scale, while the group taking two daily doses scored an average of 3.9. For the secondary measure — changes in a psychiatric symptom rating scale (where higher numbers mean more severe symptoms across 18 questions) — the reported data shows the once-daily evening group had an average change of 16.08 points, and the twice-daily group had an average change of 7.72 points. It is worth noting that what direction these changes represent (improvement or worsening from the starting point) was not clearly specified in the data as submitted, and any further detail on that was not reported in a way that can be confirmed here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01312272 · results posted 2 May 2014

According to the results reported on ClinicalTrials.gov, this trial involved 24 people in total — 12 in a group that received an inactive (placebo) nasal spray, and 12 in a group that received a nasal spray containing oxytocin, a naturally occurring hormone. Twenty-three people completed the study (one person in the oxytocin group did not finish). The trial was measuring social cognition — that is, the ability to understand and respond to other people's emotions and social cues — across several different tasks, as well as general psychiatric symptoms in people with schizophrenia. The reported data shows that, for the main (primary) outcome — a combined score across four social cognition tasks — the inactive spray group showed a change of +0.10 and the oxytocin group showed a change of +0.23 (both measured as z-scores, a way of putting different tests onto the same scale so they can be compared). For the individual secondary measures: on a theory of mind task (understanding others' intentions), the reported changes were -0.01 for the inactive spray group and +0.18 for the oxytocin group; on an empathy task, +0.24 versus +0.61; on a social perception task, +0.15 versus 0.00; and on a facial emotion recognition task, +0.05 versus +0.22. For general psychiatric symptoms (measured on a standard rating scale where a larger decrease means fewer symptoms), the inactive spray group showed a change of -10.83 points and the oxytocin group showed a change of -8.89 points. It is worth noting that this was a small study with only around 12 people per group, which limits how much can be read into the numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00784238 · results posted 27 March 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 289 people who were already taking an antipsychotic medication but had switched to a drug called paliperidone extended-release (ER). Participants were grouped according to why they had switched from their previous medication — because it wasn't working well enough (the "lack of efficacy" group), because of side effects they were experiencing (the "lack of tolerability" group), or because they had difficulty sticking to their previous medication routine (the "lack of compliance" group). The trial ran for 24 weeks and its main focus was measuring how participants felt in themselves while taking the medication, using a questionnaire called the SWN-20 scale. This scale asks 20 questions about things like mental functioning, self-control, emotional regulation, physical functioning, and social integration, with scores ranging from 20 (poorest subjective experience) to 120 (best subjective experience). Of the 289 people who started, 170 completed the study and 119 did not. The reported data shows that at the 24-week mark, the overall average SWN-20 total score across all participants was 77.89 out of 120. When broken down by group, the reported starting (baseline) scores were 74.59 for the lack-of-efficacy group, 76.51 for the lack-of-tolerability group, and 81.19 for the lack-of-compliance group. The reported changes from those starting scores to week 24 were −1.59, −2.66, and −0.93 respectively — meaning the scores in all three groups were slightly lower at week 24 than at the start of the study (noting that a lower score indicates a poorer subjective experience on this scale). The reported data shows similarly small changes across each of the five subscales (mental functioning, self-control, emotional regulation, physical functioning, and social integration) in all three groups, with the numbers shifting by less than one point in either direction over the 24 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00992407 · results posted 11 March 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 37 people in the long-acting injection group and 38 people in the tablet group — 75 participants in total. The trial was measuring how well people with schizophrenia were managing their personal and social lives over 52 weeks (about one year), comparing a long-acting risperidone injection given periodically with risperidone taken as a daily tablet. It is worth noting that a large number of participants did not complete the study — 31 out of 37 in the injection group and 24 out of 38 in the tablet group dropped out before the end. The reported data shows that the main thing being measured was a score on the Personal and Social Performance (PSP) scale, which runs from 1 to 100 (higher scores mean better day-to-day functioning). At the start of the study, the injection group had an average score of about 50.7 and the tablet group about 58.7. By week 52, both groups showed a small average increase — about 5.4 points in the injection group and about 6.0 points in the tablet group. The reported data also shows results from several other assessments, including a symptom scale (PANSS), a clinician's rating of illness severity (CGI-S), and measures of social functioning. On the symptom scale (scored 30–210, where higher means more severe symptoms), average scores decreased by about 11.7 points in the injection group and 13.0 points in the tablet group. On the severity rating (scored 1–7), both groups showed a small decrease of around 0.6–0.7 points. Changes on the social functioning and emotional functioning scales were also small in both groups; the specific figures varied across the different sub-measures reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00761189 · results posted 5 March 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 491 participants, all of whom received a medication called paliperidone extended-release (a slow-release tablet used in the treatment of schizophrenia). Of those who started, 306 completed the trial and 185 did not. The trial was measuring how participants' overall condition changed over time, how well they were able to manage day-to-day personal and social activities, and how many stayed on a specific daily dose throughout the 12-week study period. The reported data shows that the main thing being measured — called the CGI-I, a 7-point scale where doctors rate how much a person's condition has changed since the start — found that approximately 35% of participants in the main analysis group were rated as "much improved" or "very much improved" by the end of the study. In a more restricted group of participants who closely followed the study rules, that figure was reported as approximately 42%. For a separate measure of personal and social functioning (scored from 1 to 100, where higher scores indicate better day-to-day functioning), the reported average scores across three time points moved from around 49 at the start, to approximately 59, and then to around 63 by the end of the study — a similar pattern was seen in both analysis groups. Regarding the dose question, approximately 39% of the main group and 42% of the closely-followed group were reported to have stayed on the standard 6 mg daily dose for the full 12 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00392197 · results posted 12 February 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled two groups of people with conditions being treated with an antipsychotic medicine. One group of 48 people had never previously taken antipsychotic drugs, and a second group of 63 people had taken antipsychotic drugs before. In total, 111 people started the trial. Of these, 27 from the first group and 33 from the second group completed it, meaning a significant number of participants did not finish — 21 and 30 respectively. The trial was measuring blood sugar levels and a longer-term blood sugar marker (HbA1c, which reflects average blood sugar over roughly three months) to track how these figures changed during the treatment period. The reported data shows that when looking at blood sugar levels reaching or exceeding a higher threshold (126 mg/dL for a fasting test), no participants in either group crossed that mark. For a lower threshold (110 mg/dL fasting), the data shows 1 person in the antipsychotic-naïve group and 4 people in the previously treated group reached or exceeded that level at least once. For the non-fasting versions of these thresholds, the data shows 0 participants in the antipsychotic-naïve group and 1 participant in the previously treated group exceeded the relevant level. Regarding HbA1c, the reported data shows that no participants in either group reached the measured thresholds of 6.5% or above, and no participants were reported at 5.8% or above either. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00509067 · results posted 7 February 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 43 people in total — 19 in the group that received a combination of two medications (galantamine and CDP choline), and 24 in the group that received dummy pills (placebos). The trial was measuring negative symptoms of a psychiatric condition — things like emotional withdrawal, reduced facial expression, and difficulty engaging in conversation — using a standard rating tool called the PANSS. Scores on this tool ranged from 5 (no symptoms) to 35 (extremely severe symptoms). The trial also looked at overall illness severity and verbal memory (the ability to learn and recall words). The reported data shows that, at the start of the trial, both groups had similar average negative symptom scores — around 17.6 for the medication group and 18.3 for the placebo group. Over the course of the trial, the medication group's average score appeared to fall, reaching around 13.9 by the later time points, while the placebo group's score also fell but to a lesser extent, ending around 16.1 to 17.3 across the later measurements. For overall illness severity (rated 1 to 7, where higher means more severe), both groups started at around 4.3–4.4 and both showed some reduction over time, with scores in the range of 3.7–4.0 by the end. For the verbal memory test, the reported data shows the medication group's average word recall score rose from 20.5 to 23.0 over the course of the trial, while the placebo group's score went from 20.6 to 20.4. It is worth noting that relatively small numbers of people completed the trial — 15 in the medication group and 19 in the placebo group — and no information about side effects or statistical significance was included in the data submitted to ClinicalTrials.gov, so those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00132314 · results posted 20 December 2013

According to the results reported on ClinicalTrials.gov, this trial involved 382 people in total — 190 assigned to receive a long-acting injectable form of risperidone (a type of antipsychotic medication given as a regular injection) and 192 assigned to take an oral antipsychotic (a tablet taken by mouth). The trial ran for up to 24 months and was primarily measuring how long participants went without being admitted to a psychiatric hospital, comparing the two groups. The reported data shows that for the oral antipsychotic group, the average time without a psychiatric hospitalisation was approximately 1.97 years (just under two years). For the injectable risperidone group, this figure was listed as "NA" (not available), meaning a comparable single summary number was not reported for that group. The trial also tracked the number of participants who were hospitalised: in the injectable risperidone group, 72 out of 115 participants were recorded in relation to a hospitalisation event; in the oral antipsychotic group, the corresponding figures were 81 out of 101 participants. A statistical measure called a hazard ratio — which compares the rate of hospitalisation between the two groups over time — was calculated using these numbers, though the final ratio value itself was not included in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01348100 · results posted 8 October 2013

According to the results reported on ClinicalTrials.gov, this trial looked at how the body absorbs and processes a long-acting injectable form of a medicine called iloperidone. The trial ran in three phases (A, B, and C) and tested different doses and two different formulations — a crystalline (solid crystal) form and a microparticle (tiny particle) form. In total, 81 people took part across all groups. The trial was primarily measuring how the medicine moved through participants' bloodstreams after injection — specifically how the peak level of the medicine in the blood compared to the average level over time, and what the average blood concentration looked like across different doses. The reported data shows that in Phase B, where the two 250 mg formulations were compared, the ratio of peak blood level to average blood level was 1.91 for the crystalline formulation and 1.87 for the microparticle formulation — meaning the peak was roughly 1.9 times the average in both cases. The time it took to reach that peak blood level differed notably: about 48 hours for the crystalline formulation and 168 hours (7 days) for the microparticle formulation. For Phase C, the reported data shows that average blood concentrations increased as the dose went up — across two separate injection rounds, the 250 mg microparticle group recorded averages of 3.73 and 4.52 ng/mL (nanograms per millilitre, a measure of how much medicine was in the blood), the 500 mg group recorded 7.93 and 10.1 ng/mL, and the 625 mg group recorded 11.8 and 16.0 ng/mL. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01726335 · results posted 24 July 2013

According to the results reported on ClinicalTrials.gov, this trial (NCT01726335) involved 53 people who received a prolonged-release form of risperidone, a medication used in the treatment of schizophrenia. Of those 53 participants, 29 completed the study and 24 did not finish. The trial tracked participants over 24 weeks and was measuring changes in schizophrenia-related symptoms using two rating scales completed at regular check-in points. The primary measure used was the Positive and Negative Syndromes Scale (PANSS) — a 30-item questionnaire where clinicians rate the severity of various schizophrenia symptoms. Scores on this scale can range from 30 (least severe) to 210 (most severe). The reported data shows that the average PANSS total score across participants was 55.53 at week 2, 53.82 at week 4, 51.28 at week 8, 50.55 at week 16, and 48.95 at week 24. A starting (baseline) PANSS score was not reported in the submitted data. The secondary measure was the Clinical Global Impressions – Disease Severity score, where a clinician rates overall illness severity on a scale of 1 ("not at all ill") to 7 ("extremely ill"). The reported data shows average scores across multiple time points of 3.55, 3.37, 3.30, 3.21, 3.10, 2.92, 2.94, and 3.19 respectively, though the exact time points these individual scores correspond to were not clearly labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01182727 · results posted 14 June 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people, and all 10 completed the study. The trial involved a medication called salsalate, and the main thing researchers were measuring was whether participants experienced side effects while taking it. Side effects were tracked using a standard checklist designed to monitor common reactions to medication. The reported data shows that out of the 10 participants, 3 reported experiencing side effects as recorded on the side effect checklist. No other outcome measures — such as secondary outcomes — appear to have been submitted or reported in the data provided on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00316303 · results posted 22 May 2013

According to the results reported on ClinicalTrials.gov, this trial involved 236 people in total — 118 in a group receiving something called the "STIRR Intervention" and 118 in a control group (a comparison group that did not receive the intervention). The trial was measuring things related to hepatitis and HIV — specifically, whether participants got vaccinated against Hepatitis A and B, whether they got tested for Hepatitis B, Hepatitis C, or HIV, and whether those already infected with Hepatitis C were referred for medical care. By the end of the study, 107 people in the intervention group and 102 in the control group had completed the trial. The reported data shows the following numbers at the six-month mark. Of those who were not already vaccinated at the start, 73 people in the intervention group and 4 in the control group had received Hepatitis A and B vaccination. For testing, 70 intervention group participants reported being tested for Hepatitis C, compared to 10 in the control group; 69 versus 14 reported being tested for Hepatitis B; and 18 versus 6 reported being tested for HIV. For participants who were already infected with Hepatitis C, 17 in the intervention group and 12 in the control group reported being referred for medical care. These numbers reflect what participants self-reported, meaning they are based on what people said rather than independently verified records. The reported data shows differences in the counts between the two groups across all five measures, but what those differences mean in a broader sense is a matter for medical professionals to interpret. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00823199 · results posted 3 May 2013

According to the results reported on ClinicalTrials.gov, this trial involved 10 people who received a treatment called allopurinol. Eight participants completed the study, while two did not finish. The trial was looking at whether allopurinol had any measurable effect on symptoms of schizophrenia, as well as potential movement-related side effects sometimes caused by psychiatric medications (a condition called drug-induced parkinsonism, where a person may experience stiffness or tremors similar to Parkinson's disease). The reported data shows that on the main symptom measure — a scale called the PANSS, which runs from 30 (no symptoms) to 210 (most severe symptoms) — scores appeared to shift from 95 to 75 over the course of the study. For the secondary measure looking at movement-related effects (the Simpson Angus Scale, scored from 0 meaning no issues to 36 meaning most severe), the reported scores moved from 0.37 to 1.75. Additionally, as a follow-up measurement, blood levels of a substance called uric acid — which allopurinol is known to affect — were reported to have changed from 5.9 to 3.8 milligrams per decilitre. It is worth noting that the data as submitted does not clearly label which figures represent the start and end of the study, and no comparison group (such as a placebo group) was included in the reported results. With only 10 participants and no comparison group, the reported data shows only a small snapshot of measurements from this single group of people. The trial does not allow for broader conclusions to be drawn about the treatment's effects in a wider population. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00816907 · results posted 27 March 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 146 participants in total — 71 in the placebo group and 75 in the metformin group. The trial ran for up to 16 weeks and was primarily measuring the difference in body weight change between people taking metformin and people taking a placebo (an inactive dummy tablet). A number of participants did not complete the trial: 13 from the placebo group and 17 from the metformin group finished early, leaving 58 completers in each group. The reported data shows that, on average, participants in the placebo group lost 1.0 kilogram over the study period, while participants in the metformin group lost 3.0 kilograms — a reported difference of 2.0 kilograms between the two groups. The trial also measured several blood markers over 16 weeks. For total cholesterol (a measure of fatty substances in the blood), the placebo group showed a small average rise of 0.2 mg/dL, while the metformin group showed an average fall of 8.9 mg/dL. For LDL cholesterol (often called "bad" cholesterol), the placebo group averaged a fall of 2.0 mg/dL compared with a fall of 7.1 mg/dL in the metformin group. HDL cholesterol (often called "good" cholesterol) showed small average falls in both groups — 0.4 mg/dL in the placebo group and 0.6 mg/dL in the metformin group. Triglycerides (another type of fat in the blood) rose on average by 13.2 mg/dL in the placebo group and fell by 7.0 mg/dL in the metformin group. Finally, fasting blood glucose (blood sugar measured after not eating) fell slightly in both groups — by 1.6 mg/dL in the placebo group and 2.3 mg/dL in the metformin group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00954122 · results posted 8 January 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people who were given an extended-release form of a medication called quetiapine fumarate (brand name Seroquel XR). The trial was measuring changes in agitation and broader psychiatric symptoms in people with conditions such as schizophrenia, using a set of standardised rating scales over 21 days. Of the 35 people who started, 28 completed the trial and 7 did not finish. The reported data shows that the main thing being measured was a score called the PANSS-EC (a scale that rates agitation-related behaviours such as excitement, hostility, and poor impulse control, scored from 5 to 35 where higher numbers mean more severe symptoms). The reported average change from the start of the trial to the end was a reduction of 7.5 points on this scale. For secondary measures, the reported data shows an average reduction of 33.2 points on the overall PANSS total score (which runs from 30 to 210), a reduction of 9.3 points on the positive symptoms subscale, a reduction of 5.7 points on the negative symptoms subscale, and a reduction of 1.2 points on a separate overall severity rating (the CGI-S, a 7-point scale). For the CGI-I (a 7-point improvement rating scale), two figures were reported — 3.9 and 2.4 — though the data does not make clear what time points these correspond to. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00566735 · results posted 3 December 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 39 people in total — 20 in the placebo group and 19 in the galantamine group. The study was looking at whether galantamine (a medication) made any difference for people receiving electroconvulsive therapy (ECT), a treatment sometimes used for severe depression. The trial tracked three things: the number of side effects reported, how well participants' memory was functioning (using a standardised memory test called the Delayed Memory Index, or DMI), and how severe their depression symptoms were at the start (using a depression rating scale called the HAM-D-17). Not everyone finished the study — 18 people in the placebo group and 12 in the galantamine group completed it, with 7 people in the galantamine group not completing the trial. The reported data shows that the placebo group reported 19 side effects in total, while the galantamine group reported 13. For the memory test, scores were recorded at the start of the study (before ECT began) and again at discharge (after ECT ended). The placebo group had an average starting score of 80.33, which dropped to 68.50 by discharge. The galantamine group had an average starting score of 88.75, which was 88.17 at discharge. To put the scoring in context, higher numbers on this scale (which runs from 40 to 137) indicate better memory functioning. For depression symptoms at the start of the trial, the placebo group averaged 24.53 on the HAM-D-17 scale and the galantamine group averaged 27.33 — both of which fall in the range the scale describes as severe depression (above 23). It is worth noting that the number of people who dropped out — particularly in the galantamine group — was relatively high, which the researchers would need to account for when interpreting these figures. The reported data shows only the raw numbers as submitted to ClinicalTrials.gov, and no further breakdown or analysis results were included in the structured data for this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00345033 · results posted 13 September 2012

According to the results reported on ClinicalTrials.gov, this trial involved 38 people in total — 20 in the aripiprazole (a medication) group and 18 in the placebo (inactive treatment) group. The trial ran for 8 weeks and was measuring whether aripiprazole had any effect on several physical health markers, including cholesterol levels, body weight, body mass index (BMI — a measure of body size based on height and weight), blood sugar processing, triglycerides (a type of fat found in the blood), and insulin resistance (how well the body responds to the hormone that controls blood sugar). By the end of the study, 16 people in the aripiprazole group and 14 in the placebo group had completed the trial, with 4 people in each group not finishing. The reported data shows the following changes from the start of the trial to week 8. For total cholesterol, the aripiprazole group showed a decrease of 15.3 mg/dL, while the placebo group showed an increase of 5.6 mg/dL. For weight, the aripiprazole group showed a decrease of 1.5 kg, compared with a small increase of 0.3 kg in the placebo group. BMI followed a similar pattern, with the aripiprazole group recording a decrease of 0.52 kg/m², versus virtually no change (0.03 kg/m²) in the placebo group. For triglycerides, both groups showed small decreases — 5.9 mg/dL in the aripiprazole group and 7.3 mg/dL in the placebo group. For glucose metabolism and insulin resistance, the reported data shows only very small numerical differences between the two groups, with both groups recording similar scores by week 8. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00681629 · results posted 30 July 2012

According to the results reported on ClinicalTrials.gov, this trial (NCT00681629) enrolled a total of seven people across two groups: five participants received Quetiapine XR (an extended-release antipsychotic medication) alongside an Integrated Care Program, and two participants received Quetiapine XR on its own. The trial was designed to measure how people with schizophrenia or related psychotic disorders felt about their own wellbeing, as well as how their symptoms and day-to-day functioning changed over time, using several standardised rating scales. The reported data shows that none of the seven participants completed the trial — all five in the first group and both participants in the second group did not finish the study. Because no participants completed the trial, the reported data contains no outcome measurements for any of the scales that were planned to be assessed. This includes the primary measure of personal wellbeing (the SWN-K scale) and all secondary measures covering symptom severity, overall functioning, and social and personal performance. No numerical results were submitted for any of these measures. The reported data shows that, due to the very small number of participants enrolled and the fact that none completed the study, no conclusions about the outcomes being measured can be drawn from the figures submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00946985 · results posted 16 July 2012

According to the results reported on ClinicalTrials.gov, this trial involved a single group of participants who were all given an injectable medication called paliperidone palmitate. The trial was designed in two stages: a 25-week "stabilisation phase" followed by a "relapse prevention phase" of up to 24 months. The main thing the trial set out to measure was how long it took before participants experienced a return of their symptoms (called a "relapse") during that second phase. A total of 162 people entered the stabilisation phase. The reported data shows that the trial did not progress as planned. Of the 162 people who started the stabilisation phase, only 2 completed it and moved on to the relapse prevention phase. Neither of those 2 participants completed the relapse prevention phase either. Because so few participants made it through to the main measurement stage, the reported data shows no results at all for the primary outcome — that is, the time-to-relapse figures were not reported. No outcome numbers are available from this trial. It is not clear from the submitted data why so many participants did not complete the stabilisation phase, and this information was not included in the results as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00640601 · results posted 22 June 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 295 people, all of whom received Seroquel XR (a medication used for schizophrenia). Of those who started, 183 completed the study and 112 did not finish. The trial was measuring how participants' overall clinical picture changed over 24 weeks, looking at a combination of how well the treatment appeared to be working alongside any burden from side effects, as rated by the treating doctor. Several standardised rating scales were used to track symptoms and day-to-day functioning. The reported data shows that for the main outcome — a doctor-rated scale called the CGI-CB, which runs from 1 (strong benefit, no side-effect burden) to 10 (side effects outweigh any benefit) — around 56.9% of participants showed an improved score compared to their starting point. The reported average change on that same scale was 1.41 points. For a separate symptom measure called the PANSS (which tracks schizophrenia symptoms on a scale where higher numbers mean more severe symptoms), the reported average change in the total score was 10.95 points, with smaller changes also reported for the positive symptoms sub-score (2.36 points) and negative symptoms sub-score (3.67 points). A measure of overall day-to-day functioning, rated out of 100 where higher is better, showed a reported average change of 5.54 points. The reported data does not indicate in which direction these changes occurred for the individual sub-scores, so the direction of those specific changes is not clear from the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00970281 · results posted 22 February 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 91 people in total — 46 received a 10 mg intramuscular injection of olanzapine and 45 received a placebo (an inactive injection). The trial was measuring levels of agitation and excitement in participants, using a scoring tool called the PANSS-EC, which rates five signs — excitement, hostility, tension, uncooperativeness, and poor impulse control — on a scale where a higher score means more severe symptoms. The trial tracked how scores changed over the hours following the injection. The reported data shows that, for the main (primary) outcome measured at two hours after the first injection, the olanzapine group's PANSS-EC score dropped by an average of 9.2 points from their starting score, while the placebo group's score dropped by an average of 2.8 points. For a secondary measure looking at the proportion of participants whose scores fell by 40% or more within two hours, the reported data shows this occurred in 40% of the olanzapine group compared with 13.6% of the placebo group. At 24 hours after the injection, the reported average score reduction was 5.6 points in the olanzapine group and 2.8 points in the placebo group. The reported data also shows that a movement-related side-effect scale (DIEPSS) found that approximately 4.7% of olanzapine participants and 6.8% of placebo participants showed some relevant symptoms; figures for other specific movement-related categories were reported as 0% in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00753506 · results posted 20 February 2012

According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called artemisinin compared to a placebo (a dummy treatment with no active ingredient) in people with symptoms related to psychosis. A total of 66 people took part — 33 in the artemisinin group and 33 in the placebo group. Of those, 26 people in the artemisinin group and 31 in the placebo group completed the study. The main thing the trial was measuring was change in psychiatric symptoms using a tool called the PANSS (Positive and Negative Syndrome Scale), which rates the severity of 30 different symptoms on a scale from 1 to 7, where higher numbers mean more severe symptoms. The total PANSS score can range from 30 to 210. The reported data shows that at the start of the study, the artemisinin group had an average total PANSS score of 64, and the placebo group had an average of around 68. By the end of the treatment period, the artemisinin group's average total score had moved to approximately 61, while the placebo group's moved to around 66. Scores for the specific "positive symptoms" (such as hallucinations or delusions) went from about 15 to 15 in the artemisinin group, and from about 16 to 16 in the placebo group. Scores for "negative symptoms" (such as reduced emotion or motivation) went from about 19 to 19 in the artemisinin group, and from about 20 to 19 in the placebo group. For the secondary outcomes — which looked at cognitive functioning and everyday practical skills — the reported data shows no results were submitted to ClinicalTrials.gov for those measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00498550 · results posted 19 January 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people in total — 15 in a group receiving clozapine (a type of antipsychotic medication) and 16 in a group receiving their usual treatment. The trial was looking at cannabis use in people with a mental illness, specifically measuring how many joints participants smoked per week over the course of the study. All 15 participants in the clozapine group completed the trial, while 15 out of 16 in the usual treatment group completed it. The reported data shows that, based on a statistical modelling approach designed to estimate what would have happened if all participants had stayed on their assigned treatment throughout the study, the average number of joints smoked per week was reported as 0.02 in the clozapine group and 4.56 in the treatment-as-usual group. These figures are model-based estimates — meaning they are calculated numbers rather than simple averages — and were measured using a method called the Timeline Followback Scale, where participants were asked to recall their cannabis use week by week. It is worth noting that this was a small trial with only around 15–16 people in each group, and the results as submitted reflect only what was observed and modelled within this study. The reported data shows a difference in the estimated figures between the two groups, but what that means in a broader context is not something that can be concluded from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00088465 · results posted 11 January 2012

According to the results reported on ClinicalTrials.gov, this trial involved 931 people, all of whom received a medication called intramuscular olanzapine depot — an injection-form of olanzapine given into the muscle. The trial was designed to track safety-related events over a long period, and also to measure changes in schizophrenia symptom scores using two standard rating tools: the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression – Severity (CGI-S) scale. Of the 931 people who started the trial, 370 completed it, while 561 did not complete it (the reasons for not completing were not detailed in this data summary). The reported data shows that the primary thing being measured was the number of participants who experienced adverse events — that is, unwanted or unexpected medical occurrences during the trial. According to the results, 501 participants were reported as having non-serious adverse events, and 170 were reported as having serious adverse events. For the secondary measures, the PANSS total score — which runs from 30 (no symptoms) to 210 (most severe) — showed an average change of +0.30 points from the start of the trial to around the 76-month mark, meaning the group's average score was almost unchanged. The positive symptoms sub-score changed by +0.21, the negative symptoms sub-score changed by −0.08, and the general symptoms sub-score changed by +0.19. The CGI-S score — a 1-to-7 scale where lower numbers mean less severe illness — showed an average change of −0.17 points by around 72 months, again a very small shift from the starting point. It is worth noting that these are average figures across all participants, and the trial ran for a very long time — up to around six to seven years. The reported data shows changes close to zero on the symptom scales, though what this means in practice for any individual is not something this summary can address. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00129441 · results posted 17 October 2011

According to the results reported on ClinicalTrials.gov, this trial involved 15 people in total — 9 who received a treatment called L-830982 and 6 who received a placebo (a dummy treatment with no active ingredient). All 15 participants completed the study with no drop-outs. The trial was measuring how well people with schizophrenia performed on a series of thinking and memory tasks, specifically tasks designed to test working memory (holding information in mind over a short period) and the ability to control attention and override automatic responses. A standard psychiatric symptom rating scale was also assessed. The reported data shows the following numbers across the main (primary) tasks. On the N-back memory task, the L-830982 group had a reaction time of 786 milliseconds compared with 684 milliseconds in the placebo group, and an error rate of 0.239 (roughly 24 errors in every 100 attempts) versus 0.297 (roughly 30 in 100) for placebo. On the attention test known as the AX Continuous Performance Test, the L-830982 group recorded a score of 1.9 on a measure called d-prime (a number that reflects how well someone distinguishes targets from non-targets), compared with 0.7 for the placebo group. On the Preparing to Overcome Prepotency (POP) task — which measures the ability to override an automatic response — the L-830982 group had a reaction time of 57 milliseconds versus 66 milliseconds for placebo, and an error rate of 0.042 versus 0.031. For the secondary outcome, a psychiatric symptom scale scored out of a possible 18–126 (where higher means more severe symptoms) showed a reported average of 26.3 for the L-830982 group and 27.0 for the placebo group. It is worth noting that this was a very small trial with only 15 participants, and the results as submitted to ClinicalTrials.gov do not include any further statistical detail beyond these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00856583 · results posted 1 August 2011

According to the results reported on ClinicalTrials.gov, this trial compared two medications — sertindole and risperidone — in people with schizophrenia. Almost 9,809 participants took part in total, with roughly 4,905 assigned to sertindole and 4,904 to risperidone. The trial was primarily measuring two things: how many people died from any cause during and shortly after treatment, and how many people needed to go to hospital because of a heart-related event involving an irregular heartbeat (arrhythmia). The reported data shows that, for all-cause mortality (deaths from any reason), 64 people in the sertindole group and 61 in the risperidone group died during the broader treatment-plus-30-days period; in a narrower "on treatment only" period, the numbers were 40 and 44 respectively. For the second primary outcome — hospitalisations due to cardiac events including arrhythmias — 10 participants were reported in the sertindole group and 6 in the risperidone group. The trial's notes explain that the originally planned analysis for this second outcome could not be run as intended due to low numbers of events, so a broader replacement analysis was used instead. The reported data also includes breakdowns of deaths by category, assessed by an independent safety committee. Cardiac-related deaths were recorded for 31 sertindole participants and 12 risperidone participants. Deaths classified as completed suicides numbered 14 in the sertindole group and 21 in the risperidone group. Deaths falling into neither of those two categories were reported as 19 (sertindole) and 28 (risperidone). A separate classification system based on investigator reports recorded cardiac deaths as 17 (sertindole) and 8 (risperidone). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00206102 · results posted 13 July 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 596 people in the quetiapine fumarate group and 502 people in the risperidone group — 1,098 participants in total. The trial was designed to look at whether either medication was linked to changes in the lens of the eye (a potential early sign of cataracts), as assessed by two independent eye specialists who did not know which treatment each participant was receiving. The eye specialists used a standard grading tool called the LOCS II scale to score any clouding of the lens. The trial also tracked changes in psychiatric symptoms over 24 months using a standardised rating tool called the PANSS scale, which measures the severity of psychosis-related symptoms. The reported data shows that, for the eye-related (primary) outcomes, very small numbers of participants in both groups were found to have lens changes meeting the trial's defined thresholds. For clouding in the outer layer of the lens (cortical type), 2 participants in the quetiapine group and 8 in the risperidone group met the criteria. For clouding in the central core of the lens (nuclear type), 0 participants in the quetiapine group and 2 in the risperidone group met the criteria. For clouding at the back of the lens (posterior subcapsular type), 4 participants in the quetiapine group and 7 in the risperidone group met the criteria. It is worth noting that a large proportion of participants did not complete the study — 408 in the quetiapine group and 315 in the risperidone group did not finish — which the reported data does not explain further. The reported data also shows changes in PANSS symptom scores over 24 months. Both groups showed a reduction in total PANSS scores (a lower score suggests fewer or less severe symptoms), with the quetiapine group showing an average reduction of 9.1 points and the risperidone group showing an average reduction of 8.6 points, out of a possible range of 30 to 210. Scores for "positive" symptoms (such as hallucinations) fell by an average of 2.7 points in the quetiapine group and 2.8 points in the risperidone group. Scores for "negative" symptoms (such as reduced motivation) fell by an average of 2.2 points in the quetiapine group and 1.5 points in the risperidone group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00044005 · results posted 19 May 2011

According to the results reported on ClinicalTrials.gov, this trial looked at three different doses of a medication called lurasidone (20 mg, 40 mg, and 80 mg) over a six-month period. A total of 98 people took part — 32 in the 20 mg group, 33 in the 40 mg group, and 33 in the 80 mg group. The main thing the trial was set up to measure was how many participants experienced adverse events (that is, unwanted or unexpected health occurrences) while taking the medication. The reported data shows that, of those who started the trial, 13 people in the 20 mg group, 19 in the 40 mg group, and 11 in the 80 mg group finished the full six months. Regarding adverse events, the reported figures show that 19 out of 32 participants in the 20 mg group, 22 out of 33 in the 40 mg group, and 18 out of 33 in the 80 mg group experienced at least one adverse event. No further breakdown of what those adverse events were is included in the data provided. It is also worth noting that no secondary outcome measures were reported in the structured data submitted to ClinicalTrials.gov for this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00088621 · results posted 6 May 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 61 people, all of whom received a daily dose of 80 mg of a medication called lurasidone. The study ran for one year as an open-label trial, meaning all participants knew which treatment they were receiving. Of the 61 people who started, only 7 completed the full year, while 54 did not finish the study. The main thing the trial was set up to measure was how many participants experienced adverse events — that is, any unwanted or unexpected health occurrences reported during the study period. The reported data shows that 59 out of 61 participants experienced at least one adverse event over the course of the year. No secondary outcome measures were included in the submitted results data. It is important to note that an adverse event being recorded does not automatically mean it was caused by the medication — it simply means it was reported and noted during the study period. The trial did not appear to include a comparison group receiving a different treatment or a placebo, so there is no comparison figure available in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00194025 · results posted 1 March 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people, all of whom received the medication valproate. Of those, 15 people completed the study and 5 did not. The trial was measuring changes in several areas for people with schizophrenia, including the severity of schizophrenia symptoms, thinking and memory, overall day-to-day functioning, depression, and general mental and physical health. The reported data shows the following changes from the start of the trial to its end. For the main measure — a schizophrenia symptom scale called the PANSS (where lower scores are better, ranging from 30 to 210) — the reported average change was −17.45 points, meaning scores moved toward the lower (better) end of the scale on average. For the secondary measures: a thinking and memory test called the MMSE showed an average change of +0.4 points (higher is better on this scale); an overall functioning scale called the GAS showed an average change of +16.35 points (higher is better); a depression scale called the GDS showed an average change of −1.556 points (lower is better on this scale); a mental health quality-of-life measure (MCS from the SF-36) showed an average change of +5.298 points (higher is better); and a physical health quality-of-life measure (PCS from the SF-36) showed an average change of +0.932 points (higher is better). It is worth noting that this trial had only one group — everyone received valproate — so there was no comparison group receiving a different treatment or a dummy pill. This means the reported numbers describe what was observed in this one group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00615433 · results posted 14 February 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 478 people across four groups. Participants were randomly assigned to receive one of two doses of an investigational treatment (40 mg or 120 mg), a comparison medication called olanzapine (15 mg), or a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in schizophrenia symptom scores over the course of the double-blind treatment period — meaning neither participants nor their doctors knew which treatment each person was receiving. By the end of the study, the number of people who completed the trial ranged from 66 to 84 across the four groups, meaning a notable proportion in each group did not finish. The reported data shows results on two rating scales. The first was the PANSS — a 30-item scoring tool where higher numbers mean more severe symptoms, with a total possible range of 30 to 210. Lower scores at the end of the trial (compared to the start) indicate a reduction in reported symptom severity. The reported average change in PANSS score from the start to the end of the study was: minus 25.7 points for the 40 mg group, minus 23.6 points for the 120 mg group, minus 28.7 points for the olanzapine group, and minus 16.0 points for the placebo group. The second measure was the CGI-S, a 1–7 scale where a clinician rates overall illness severity. The reported average change here was: minus 1.5 for the 40 mg group, minus 1.4 for the 120 mg group, minus 1.5 for the olanzapine group, and minus 1.1 for the placebo group. In both cases, a minus figure means the score went down (i.e., reported severity was lower) compared to the start of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00156715 · results posted 21 December 2010

According to the results reported on ClinicalTrials.gov, this trial involved 23 participants, all of whom received a treatment referred to in the data as "QUET." Of those 23 people, 16 completed the study and 7 did not finish. The trial was measuring alcohol use patterns and clinical symptoms in people diagnosed with schizophrenia, using structured tools to track these outcomes over the course of the study. The reported data shows that, on average, participants drank on approximately 2.7 days per week, as measured by a method called the Timeline Follow-back procedure — a calendar-based approach where participants were asked to recall their alcohol and other drug use since their last visit. For clinical symptoms, the trial used a 30-item rating scale (where scores can range from 30, meaning no symptoms detected, up to 210, meaning extreme symptoms across all areas). The reported data shows an average score of 65.5 on this scale for the group. It is worth noting that this trial had only one group, so there is no comparison group reported in the data — meaning the numbers above reflect only the single group of participants who received the study treatment. No comparison figures were reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00216476 · results posted 10 August 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 711 people in total across three groups: 329 received Risperidone LAI (a long-acting injectable medication), 337 received Quetiapine, and 45 received Aripiprazole. All participants had schizophrenia, and the trial was primarily measuring how long people went without experiencing a relapse (a return or worsening of symptoms meeting specific criteria) while taking their assigned medication. Of those who started, 224, 230, and 28 people respectively completed the study in each group. The reported data shows that the average number of days participants went without a relapse was 607 days for the Risperidone LAI group and 533 days for the Quetiapine group. For the Aripiprazole group, this figure was 314 days, though the trial notes this was an exploratory finding only, as Aripiprazole had only recently become available at the time. The trial also measured changes in symptom scores using a standard rating scale (PANSS, where lower scores mean fewer symptoms). The reported data shows average score reductions of 9.3 points for Risperidone LAI, 1.1 points for Quetiapine, and 7.7 points for Aripiprazole. Small changes were also reported on a severity rating scale and a quality-of-life survey, though the differences across groups were modest on those measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00669903 · results posted 6 August 2010

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called AZD0328 and its effect on thinking and memory tasks in people with schizophrenia. A total of 100 participants were enrolled across four groups: 23 received a low dose of AZD0328, 37 received what was called an "optimal" dose, 18 received a high dose, and 22 received a placebo (a dummy treatment with no active ingredient). The trial used a set of computerised thinking tasks to measure any changes in memory and attention after 14 days of treatment. The reported data shows that the main thing being measured was a combined score from two computerised tasks — one testing maze-learning ability and one testing how well participants recognised cards they had seen before. Higher scores on these tasks indicated improvement from the starting point. The reported figures for this combined score at day 14 were: 0.234 for the low dose group, 0.240 for the optimal dose group, and 0.194 for the high dose group, compared with 0.266 for the placebo group. The reported data also shows results for several additional thinking tasks. For the maze-learning task alone, the three AZD0328 groups scored 0.313, 0.360, and 0.281 respectively, compared with 0.235 for placebo. For the card-recognition task alone, scores were 0.150, 0.102, and 0.094 for the AZD0328 groups, compared with 0.316 for placebo. For tasks measuring reaction speed, some AZD0328 groups returned small negative numbers, meaning a slight move in the lower direction from their starting point, while the placebo group's figures were close to zero or slightly positive. For a maze-recall task, scores ranged from 0.213 to 0.467 across the AZD0328 groups, compared with 0.409 for placebo. Whether any of these differences between groups are meaningful was not described in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00508157 · results posted 20 July 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 52 people in total — 26 in a control group and 26 in an aripiprazole group. The trial was measuring changes in certain blood fat and metabolic markers over 16 weeks in people who had a cluster of health indicators known as "metabolic syndrome" (broadly, a combination of raised blood sugar, abnormal cholesterol or fat levels, high blood pressure, and a larger waist measurement). By the end of the study, 24 people in the control group and 23 in the aripiprazole group had completed it. The reported data shows that the main thing being measured was the percentage change in a blood fat called non-HDL cholesterol (total cholesterol minus the "good" HDL cholesterol) from the start of the trial to week 16. The control group showed an average increase of about 10%, while the aripiprazole group showed an average decrease of about 2.3%. For one of the secondary measures, the reported data shows that at week 16, out of those assessed, 22 participants in the control group and 16 in the aripiprazole group still met the criteria for metabolic syndrome. The reported data for several other secondary measures — including changes in individual blood fats (total cholesterol, LDL, HDL, and triglycerides), fasting blood sugar levels, body weight, and body mass index (BMI, a number based on height and weight) — were not reported in the data submitted to ClinicalTrials.gov, so no numbers for those outcomes are available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00150176 · results posted 28 May 2010

According to the results reported on ClinicalTrials.gov, this trial involved 194 people who received asenapine and 192 people who received a placebo (an inactive tablet used for comparison). The trial was looking at schizophrenia, specifically measuring how long it took for participants to experience a relapse — meaning a significant worsening of their symptoms — or signs that a relapse was about to happen. A second measure tracked how long it took for participants to leave the trial early, for any reason. Of those who started, 135 people in the asenapine group and 72 people in the placebo group completed the study. The reported data shows that, across several time intervals during the study, the number of relapses or impending relapses recorded in the asenapine group was lower than in the placebo group at each interval. For example, the reported figures across the measured time points for the asenapine group were 0, 1, 2, 2, 0, and 1 relapses, compared with 3, 14, 9, 8, 7, and 8 in the placebo group. For the secondary measure — how many participants left the trial early — the reported numbers at each time point in the asenapine group were 1, 6, 3, 5, 0, and 3 participants, compared with 2, 14, 10, 11, 11, and 7 in the placebo group. The data does not report the specific time points these intervals correspond to, so a full breakdown cannot be provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00145496 · results posted 25 March 2010

According to the results reported on ClinicalTrials.gov, this trial compared two medications — asenapine and olanzapine — in people diagnosed with schizophrenia. A total of 244 people were assigned to the asenapine group and 224 to the olanzapine group. The trial's main focus was measuring changes in what are called "negative symptoms" of schizophrenia — things like reduced motivation, flat emotions, and social withdrawal — using a rating scale called the NSA (Negative Symptom Assessment). This scale runs from 16 to 96, where higher numbers mean more severe symptoms. The trial also looked at quality of life and body weight as secondary measures. The reported data shows that, at the start of the trial, the average NSA score was 60.4 for the asenapine group and 61.3 for the olanzapine group. By the end, the asenapine group's average score had decreased by 9.7 points and the olanzapine group's by 9.2 points — meaning both groups showed a reduction in reported symptom severity on this scale. For quality of life (scored 0–126, where higher is better), the asenapine group started at an average of 46.3 and increased by 11.1 points, while the olanzapine group started at 44.2 and increased by 7.1 points. Regarding body weight, the asenapine group's average weight showed no reported change (0.0 kg), while the olanzapine group's average weight increased by 2.6 kg. It is worth noting that roughly half of those in the asenapine group (123 out of 244) and about a third of those in the olanzapine group (81 out of 224) did not complete the trial, according to the reported data — though the reasons for this were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00299702 · results posted 16 March 2010

According to the results reported on ClinicalTrials.gov, this trial compared two medications — Risperdal Consta and Abilify — in people with schizophrenia. A total of 179 people were assigned to the Risperdal Consta group and 176 to the Abilify group, making 355 participants in all. The trial was measuring two main things: how long it took before a person experienced a return of symptoms (called a "relapse"), and how long people spent in "remission" — a period where their symptoms stayed below a certain level of severity as measured by a standard rating scale. The reported data shows that, on average, people in the Risperdal Consta group took 131 days to reach a relapse, while those in the Abilify group took 113 days. For time spent in remission, the reported data shows an average of 373.5 days for the Risperdal Consta group and 356.7 days for the Abilify group. By the end of the study, 126 participants in each group had completed the trial, meaning 53 people in the Risperdal Consta group and 50 in the Abilify group did not finish — the reasons for this were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00524043 · results posted 26 February 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 200 people in total — 64 received a placebo (a dummy pill with no active ingredient), 70 received paliperidone ER at a 6 mg dose, and 66 received paliperidone ER at a lower 1.5 mg dose. The trial ran for six weeks and was primarily measuring changes in symptoms of schizophrenia using a standard psychiatrist-rated tool called the PANSS (Positive and Negative Syndrome Scale), which scores symptom severity from 30 (least severe) to 120 (most severe). Not everyone finished the trial — around half of each group completed it, with 34, 42, and 35 participants completing in the placebo, 6 mg, and 1.5 mg groups respectively. The reported data shows that all three groups had lower PANSS scores by the end of the trial compared to where they started, meaning all groups showed some reduction in recorded symptom scores. Specifically, the placebo group's score dropped by an average of 11.7 points, the 6 mg paliperidone group dropped by 15.0 points, and the 1.5 mg paliperidone group dropped by 8.9 points. For the secondary measures, the reported data shows mixed patterns. On the CGI-S scale (a 1–7 rating of overall illness severity, where lower is better), the placebo group's score fell by 1.0, the 6 mg group by 0.5, and the 1.5 mg group showed no change. On a personal and social functioning scale (scored 1–100, where higher is better), average scores increased by 1.6, 5.7, and 2.9 points for the placebo, 6 mg, and 1.5 mg groups respectively. On the two self-reported quality-of-life summary scores (physical and mental health, each out of 100), the changes reported were small across all groups, ranging from a slight decrease of 0.2 to increases of up to 6.1 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00265343 · results posted 23 February 2010

According to the results reported on ClinicalTrials.gov, this trial compared two medications — asenapine and olanzapine — in people with schizophrenia. A total of 134 people were assigned to the asenapine group and 172 to the olanzapine group, making 306 participants in all. Of those, 113 in the asenapine group and 153 in the olanzapine group completed the study. The trial was measuring changes in what are called "negative symptoms" of schizophrenia (things like reduced motivation or emotional expression) using a rating scale called the NSA, which runs from 16 (best) to 96 (worst). It also measured self-reported quality of life using a scale called the QLS, which runs from 0 (worst) to 126 (best). The reported data shows that, on the NSA scale, scores in the asenapine group dropped by an average of 16.9 points from the start of the trial, while scores in the olanzapine group dropped by an average of 15.4 points — remembering that a lower score on this scale represents fewer negative symptoms. For quality of life (QLS), scores in the asenapine group rose by an average of 18.7 points, while scores in the olanzapine group rose by an average of 16.4 points — where a higher score represents better quality of life. These are the changes observed across the duration of the study, as submitted by the trial sponsor. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00401973 · results posted 30 September 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 199 people in total across three groups: 50 people took olanzapine alone, 76 took olanzapine combined with amantadine, and 73 took olanzapine combined with metformin. The trial was measuring whether adding amantadine or metformin to olanzapine made a difference to body weight and certain blood markers — including blood fats (triglycerides and cholesterol) and blood sugar (glucose) — compared to taking olanzapine on its own. By the end of the study, 39 people in the olanzapine-only group, 50 in the olanzapine-plus-amantadine group, and 50 in the olanzapine-plus-metformin group had completed the trial. The reported data shows that the main thing being measured was change in body weight. The olanzapine-only group gained an average of 2.76 kilograms, the olanzapine-plus-amantadine group gained an average of 2.40 kilograms, and the olanzapine-plus-metformin group gained an average of 0.65 kilograms. For blood fats, the reported data shows that triglyceride levels changed by +0.33, +0.35, and +0.06 mmol/L respectively across the three groups. Total cholesterol changed by +0.36, +0.01, and −0.08 mmol/L. HDL cholesterol (sometimes called "good" cholesterol) changed by approximately 0.00, −0.11, and −0.08 mmol/L. LDL cholesterol (sometimes called "bad" cholesterol) changed by +0.16, −0.04, and −0.02 mmol/L. Fasting blood sugar levels changed by +0.26, +0.10, and +0.01 mmol/L in the three groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.