Reported trial results for Bipolar Disorder
Every Bipolar Disorder 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.
102 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
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NCT03622749 · results posted 3 March 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 19 people in total across six groups. Each group received three different conditions in a set order — a "sham" (dummy/inactive) brain stimulation session, stimulation to a brain area called the VLPFC (ventrolateral prefrontal cortex), and stimulation to a brain area called the IPL (inferior parietal lobule). One participant did not complete the study, leaving 18 who finished. The trial was measuring how brain stimulation using a technique called TMS (transcranial magnetic stimulation, which uses magnetic pulses applied to the outside of the head) affected people's speed at completing two computer tasks designed to test how well they could handle distracting emotional images or words. The reported data shows reaction times — that is, how quickly participants responded — before and after each type of stimulation session. For the first task (identifying a number shown over emotional pictures), average response times before and after sham stimulation were around 733 ms and 721 ms during negative image trials, and around 727 ms and 735 ms during positive image trials. For IPL stimulation, times went from about 723 ms to 698 ms (negative) and 734 ms to 696 ms (positive). For VLPFC stimulation, times went from about 735 ms to 706 ms (negative) and 730 ms to 704 ms (positive). For the second task (identifying an emotion word shown over a face showing a different emotion), the reported data shows similarly small differences in response times across all three conditions, ranging roughly between 675 ms and 705 ms across the various before-and-after measurements. The reported data shows these numbers as recorded in the trial, but the results do not indicate whether any differences between conditions were meaningful beyond what chance alone might produce — that detail 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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NCT05127837 · results posted 27 February 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05127837) compared two approaches to supporting people with psychosis-related experiences: a standard care approach called "Treatment as Usual" (TAU) and a digital tool called "CBTpro," which was designed to support a talking therapy known as CBT for psychosis. In total, 601 people took part across both groups — 285 in the TAU group and 316 in the CBTpro group. Each group included both clients (people receiving care) and providers (the clinicians supporting them). The trial tracked three things for the client participants: paranoid thinking, perceived progress in recovery, and how much their symptoms were affecting day-to-day life. The reported data shows that paranoid thinking was measured using a scale called the R-GPTS, where higher numbers mean more severe paranoid thoughts. At the start, both groups scored similarly (around 12 out of a possible 40 on the persecution subscale, which is below the threshold of 18 that the researchers described as clinically severe). Scores across both groups remained broadly similar throughout the study, with the CBTpro group reporting 10.7 and the TAU group reporting 13.3 at one of the later time points. For perceived recovery progress (scored 0–110, higher is better), both groups started around 6 out of 110 and showed only small changes over time, ending at 6.6 (CBTpro) and 6.1 (TAU). For day-to-day functioning difficulties (scored 0–30, lower is better), both groups started around 14 and the CBTpro group reported a score of 13.1 compared to 14.4 in the TAU group at a later time point. The reported data shows only the group-level scores at different points in time; no additional detail about the size or meaning of differences between groups 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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NCT04269772 · results posted 28 January 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04269772) involved 34 participants across three groups. Fifteen people took part in the "Community Treatment Adherence at Re-Entry" program (known as CARE), 15 received what is called "Treatment As Usual" (the standard care people would normally receive), and 4 were "Significant Others" — meaning close family members or support people involved in a participant's care. The trial was primarily measuring how satisfied participants were with their care, and also looked at self-reported ratings of depression and mania (a state of unusually high or elevated mood) symptoms. The reported data shows that, for the main measure — a satisfaction questionnaire scored from 8 to 32, where higher means more satisfied — the CARE group recorded an average score of 28.00, while the Treatment As Usual group recorded an average of 26.20. For the depression symptom scale (scored 0 to 27, where higher means more severe symptoms), the CARE group averaged 7.38 and the Treatment As Usual group averaged 7.64. The reported data shows that on the mania symptom scale (scored 0 to 20, where higher means more severe symptoms), the CARE group averaged 1.13 compared to 1.82 in the Treatment As Usual group. No additional detail about the significance or meaning of these differences between groups was included in the submitted results data. It is worth noting that this was a small trial, with only 15 people in each of the two main groups, and one participant in the CARE group did not complete the study. Because of the small numbers involved, these figures give only a limited snapshot. 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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NCT03825640 · results posted 28 January 2026
According to the results reported on ClinicalTrials.gov, this trial involved two groups: 12 people in the main participant group, called the Community Treatment Adherence at Re-Entry (CARE) group, and 6 people described as Significant Others (such as family members or close supporters). Of the 12 main participants, 11 completed the study, with 1 not finishing. The trial was measuring how acceptable and feasible a community-based treatment programme was for people returning to the community, as well as looking at self-reported scores related to depression and mania symptoms. The reported data shows that the main group scored an average of 27.90 out of 32 on the Client Satisfaction Questionnaire-8 — a tool where higher scores indicate greater satisfaction with the programme (the scale runs from 8 to 32). For depressive symptoms, the reported data shows an average score of 10.90 out of 27 on a self-report questionnaire, where higher numbers indicate more severe symptoms. For manic symptoms, the average reported score was 3.30 out of 20, again where higher numbers indicate more severe symptoms. No outcome data was reported for the Significant Others group. It is worth noting that this was a very small study, and the results reflect only the scores recorded at the time of measurement — no comparison figures or change-over-time data were included in the structured results 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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NCT06041646 · results posted 2 January 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT06041646) enrolled 29 adults who received a 180 microgram dose of a medicine called Igalmi (dexmedetomidine), which was placed under the tongue. Twenty-eight of the 29 participants completed the study, with one person not finishing. The trial was measuring changes in agitation levels using two main rating scales — one called the PEC (which scores agitation-related behaviours from 5, meaning no agitation, up to 35, meaning extremely severe agitation) and another called the CGI-I (which rates overall improvement from 1, meaning very much improved, to 7, meaning very much worse). The reported data shows that participants' PEC scores dropped by roughly 8.7 to 11.5 points across several time points measured during the study, indicating that the scores on that scale were lower (i.e., moved toward the less-agitated end) compared to where they started. On the CGI-I scale, the reported average scores ranged from 1.0 to 2.0 across the time points measured, which sits toward the "very much improved" end of that particular scale. It is important to note that this trial had only one group — everyone received the active treatment — so there was no comparison group receiving a placebo or different treatment. The reported data also shows that for the secondary outcome, zero participants experienced the specific adverse events (such as rapid heartbeat, high blood pressure, nausea, or vomiting) that the researchers were watching for during the three-day follow-up period after treatment ended. Any results not listed here 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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NCT04063384 · results posted 19 November 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people across four groups, who were each assigned to drink either alcohol or a placebo (non-alcoholic) drink on different visit days. Two of the groups were described as "binge drinkers" (BD) and two as "typical drinkers" (TD). The trial was measuring two main things: how intoxicated participants felt after drinking (using a self-reported feelings survey called the SEAS), and how activity patterns between different regions of the brain changed while participants looked at emotional images during their drink sessions. A total of 55 people completed the study, with 5 people not completing it across the four groups. The reported data shows that, on the self-reported feelings survey, scores above zero meant participants reported feeling more intoxicated effects after drinking compared to before. Among those who received alcohol first, binge drinkers reported a change score of 7.3 and typical drinkers 3.6 on one subscale (stimulation-type feelings); on another subscale (anxiety-reducing feelings), scores were 4.1 and 2.3 respectively; and on a third subscale (sedative-type feelings), scores were −1.4 and −5.3, meaning those groups reported feeling slightly less of those effects. The groups who received placebo first and then alcohol reported higher change scores overall — for example, 15.4 and 6.3 on the stimulation subscale. For the brain activity measurements, the reported data shows very small changes in the way different brain regions were communicating during the emotional image task, with values close to zero across all four groups in each condition. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05445466 · results posted 6 November 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 14 people in total, split across three groups: 5 people received a type of brain stimulation called HD-tDCS, 4 received HD-tACS tuned to an "alpha" frequency (10 Hz), and 5 received a personalised form of HD-tACS tuned to each person's own "beta-gamma" brain frequency. The trial was measuring symptoms of mania — an elevated or unusually energised mood state — using two rating tools: one completed by a clinician (the YMRS, scored 0–60) and one filled in by the participants themselves (the ASRM, scored 0–20). Measurements were taken at the start of the study, after 5 days of stimulation, at one month, and at three months. Not everyone completed all time points — by the three-month mark, only 3, 2, and 4 participants remained in each group respectively. The reported data shows the following YMRS scores (clinician-rated mania, where higher means more severe). At the start, average scores were 5.5 (HD-tDCS), 11.8 (alpha HD-tACS), and 7.5 (personalised HD-tACS). After 5 days, these were reported as 3, 8, and 3. At one month, scores were 1.5, 11, and 4. At three months, scores were 2.6, 7.5, and 2. For the self-rated ASRM scale, starting scores were 5 (HD-tDCS), 7 (alpha HD-tACS), and 3 (personalised HD-tACS). After 5 days these were 7, 2, and 5; at one month, 2, 4, and 5; and at three months, 2, 3.6, and 6. It is worth noting that a score of 6 or above on the ASRM is described as indicating a high likelihood of manic or hypomanic symptoms. The reported data should be interpreted with caution given the very small number of participants in each group, and the fact that several people did not complete the full study period — the data does not explain why. No information about unwanted effects or safety was included in the results as submitted to ClinicalTrials.gov, so that data was 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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NCT02600494 · results posted 3 November 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT02600494) enrolled 554 people across three groups: one group received a lower dose of lumateperone (28 mg), another received a higher dose (42 mg), and a third received a placebo (a dummy treatment with no active ingredient). The trial had two parts. In Part A, all three groups took their assigned treatment for six weeks in a blinded fashion, meaning participants did not know which treatment they were receiving. In Part B, a six-month open-label extension, only participants from the 42 mg lumateperone group continued, and in this phase everyone knew what they were taking. The main thing being measured was change in depression symptom severity, using a standard rating scale called the MADRS, where scores range from 0 to 60 and a lower score means fewer symptoms. The reported data shows that after six weeks (Part A), the average MADRS score fell by 18.9 points in the 28 mg lumateperone group, by 20.7 points in the 42 mg lumateperone group, and by 19.7 points in the placebo group — all starting from their individual baseline scores. For a secondary measure — how many days it took participants to first show a sustained reduction in their MADRS score — the reported data shows an average of 43 days for the 28 mg group, 38 days for the 42 mg group, and 37 days for the placebo group. Among those who continued into the six-month open-label extension (Part B) in the 42 mg group, the reported data shows an additional average drop of 8.9 points in MADRS score from their Part A baseline to Day 175. It is worth noting that not everyone completed the trial: in Part A, 57 people in the 28 mg group, 72 in the 42 mg group, and 48 in the placebo group 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00288353 · results posted 2 October 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 48 people in total — 25 in the aripiprazole (Abilify) group and 23 in the ziprasidone (Geodon) group. Of those, 18 and 16 people respectively completed the study, with 7 from each group not finishing. The trial was measuring changes in blood fat levels — specifically a ratio comparing triglycerides (a type of fat in the blood) to HDL ("good" cholesterol) — as well as body weight, BMI (a measure of body size based on height and weight), total cholesterol, HDL cholesterol, and triglycerides on their own. The reported data shows that the main measure — the triglyceride-to-HDL ratio — started at 8.1 for the aripiprazole group and 8.2 for the ziprasidone group. Across the later time points recorded, the reported figures for aripiprazole were 4.9, 4.8, and 5.7, while for ziprasidone they were 4.7, 5.6, and 5.2. For body weight, the aripiprazole group started at around 216.8 lbs and was recorded at 211.8, 211.2, and 210.9 lbs at later points; the ziprasidone group started at 216.7 lbs and was recorded at 208.8, 209.4, and 207.1 lbs. BMI figures followed a similar pattern, starting at 35.5 for both groups and trending slightly lower over time. Triglyceride levels started at around 306 mg/dL for aripiprazole and 304 mg/dL for ziprasidone, with later readings varying across time points for both groups. One cholesterol figure for the ziprasidone group at the final time point (85.9 mg/dL) appears notably different from the other readings; the data as submitted does not explain this, so no interpretation can be offered 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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NCT05328297 · results posted 11 July 2025
According to the results reported on ClinicalTrials.gov, this trial tested an investigational drug called JNJ-55308942 against a placebo (an inactive look-alike treatment) in people with bipolar depression. A total of 116 people were enrolled — 55 in the JNJ-55308942 group and 61 in the placebo group. Of those, 54 and 60 respectively actually received a treatment. By the end of the study, 42 people in the JNJ-55308942 group and 50 in the placebo group completed it. The trial's main goal was to measure changes in depression severity over six weeks using a standard clinician-rated questionnaire called the MADRS (a 60-point scale where higher scores mean more severe depression, and a falling score suggests improvement). The reported data shows that, on the primary measure, the JNJ-55308942 group's MADRS score fell by an average of 16.0 points from where it started, while the placebo group's score fell by an average of 15.4 points — a very similar result between the two groups. A secondary measure looked at a self-reported questionnaire called the SHAPS, which tracks a person's ability to feel pleasure (scored 14–56, where a falling score suggests improvement). The reported data shows the JNJ-55308942 group's score dropped by an average of 8.2 points and the placebo group's by 8.3 points — again, closely matched. Additional secondary analyses broke these depression scores down by genetic profile, bipolar type (I or II), and certain blood-based markers, and the reported figures across all those sub-groups were also broadly similar between the two groups. For a measure tracking notable changes in vital signs (such as blood pressure, heart rate, temperature, and weight), the reported data shows zero participants in either group recorded a clinically important abnormality. 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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NCT04211961 · results posted 29 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04211961) enrolled 50 people in total — 24 received a placebo (an inactive infusion) and 26 received scopolamine (a drug given by drip into a vein). Three people in the scopolamine group did not complete the study, while everyone in the placebo group finished. The trial was measuring symptoms of depression using two standard rating scales: the Hamilton Depression Rating Scale (scored 0–54, where higher numbers mean more severe symptoms) and the Montgomery-Åsberg Depression Rating Scale (scored 0–60, again with higher numbers meaning more severe symptoms). The reported data shows that after the final scheduled treatment, the average Hamilton scale score was 12.0 for the placebo group and 13.0 for the scopolamine group. The average Montgomery-Åsberg scale score at that same point was 14 for the placebo group and 16 for the scopolamine group. For the stricter measure of "remission" (defined as scoring very low on both scales at once), 2 people in each group met that threshold after the last treatment, and at a later follow-up visit, 4 people in the placebo group and 1 person in the scopolamine group met it. When looking at a broader measure — whether a person's Montgomery-Åsberg score had dropped by at least half compared to their starting point — 9 placebo participants and 7 scopolamine participants reached that mark after the last treatment, and 7 placebo participants and 6 scopolamine participants reached it 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03953417 · results posted 24 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03953417) enrolled 7 participants, all of whom completed the study with no drop-outs. The trial was testing a brain stimulation technique called Accelerated Intermittent Theta Burst Treatment — a type of non-invasive magnetic brain stimulation delivered in a faster-than-usual schedule. The main thing being measured was how scores on a depression rating scale (called the MADRS) changed from the start of the trial to the end. A secondary measurement tracked a mania rating scale (called the YMRS), which looks at symptoms like irritability and changes in speech or behaviour. The reported data shows that, on the MADRS depression scale (which runs from 0 to 60, where higher numbers mean more severe depression symptoms), participants had an average score of 40.0 at the start — a level that falls in the severe range — and an average score of 5.7 by the end, which falls in the near-absent symptoms range. For the YMRS mania scale (also 0 to 60, where higher means more manic symptoms), the reported data shows an average starting score of 0.8, dropping to 0 by the end of the trial. It is important to note that this was a very small trial of only 7 people and had no comparison group, meaning there was no separate group receiving a different or inactive treatment to compare against. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05228457 · results posted 12 March 2025
According to the results reported on ClinicalTrials.gov, this trial involved 26 people in total — 13 in each group. One person from each group did not finish the study, leaving 12 completers in each group. The trial was looking at a brain stimulation technique called Transcranial Magnetic Stimulation (TMS), where one group received real ("active") stimulation and the other received a fake ("sham") version that mimicked the experience without delivering the actual stimulation. The main thing being measured was depression symptom scores using a standard rating tool called the Montgomery-Åsberg Depression Rating Scale (MADRS), where scores range from 0 to 60 and higher scores mean more severe symptoms. The trial also looked at changes in brain activity patterns using MRI scans. The reported data shows that at the start of the trial, both groups had similar average MADRS scores — around 30.4 for the active group and 28 for the sham group. Over the course of the five treatment days and at the end of the study, the active group's average scores were reported as falling progressively: roughly 26.7, 20.3, 16.3, and finally 11.3. The sham group's scores, by comparison, remained relatively stable across the same time points, ending at around 24.8. For the brain scan part of the study, the reported data shows different patterns of brain connectivity changes between the two groups, though interpreting these numbers in plain terms is difficult without further context — they represent mathematical measures of how different brain regions were communicating with each other. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05227209 · results posted 21 February 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 64 people, all of whom received a study medication called SEP-4199 CR. The trial was an open-label study, meaning all participants knew they were receiving the drug, and it ran for up to 12 months. The main things the trial was measuring were how many participants experienced unwanted health events (called adverse events) during the study. Secondary measurements looked at changes in depression symptom scores over time using two standard rating tools used by clinicians. The reported data shows that of the 64 people who started the trial, only 9 completed it, while 55 did not complete it (the reasons for not completing were not broken down further in the reported data). On the primary measurements: 39 out of 64 participants experienced at least one adverse event; 9 participants stopped taking the study medication because of an adverse event; and 3 participants experienced a serious adverse event. For the secondary measurements, the reported data shows an average change in depression scores on the MADRS scale (a 0–60 clinician rating tool where higher scores mean more severe depression) of −6 points from the start of the open-label period to the 12-month mark — meaning scores were, on average, 6 points lower. On the CGI-BP-S depression scale (a 1–7 clinician severity rating), the average change was −0.8 points over the same period. 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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NCT03360942 · results posted 12 December 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03360942) followed five people who already had a deep brain stimulation (DBS) device implanted — a device that delivers small electrical signals to specific areas of the brain — as a treatment for depression. The trial tracked these participants over time, checking in every 12 months to see whether their device was still working and to measure their depression symptoms using several standard rating scales. The reported data shows that none of the five participants formally "completed" the study as defined by the trial protocol, with all five recorded as not having completed it; the reasons for this were not detailed in the submitted data. The reported data shows that when the devices were checked at various time points, the number of participants whose device was still functioning varied across assessments, ranging from 0 to 3 people at any given check-in. Depression symptoms were measured using several different rating scales — each a clinician-scored questionnaire where higher numbers mean more severe depression. On the 17-item Hamilton scale (where scores of 18–24 suggest moderate depression and 25 or above suggests severe depression), scores of 18 and 24 were reported across two time points. On the 21-item version, scores of 22 and 25 were reported, both in the severe-to-very-severe range. On the 24-item version, scores of 29.5 and 28 were reported; on the 28-item version, scores of 32.5 and 31. On the MADRS scale (where 20–34 suggests moderate depression and 35 or above suggests severe), scores of 25 were reported at both time points. It is not clear from the submitted data at exactly which time points each of these scores was recorded. It is worth noting that with only five participants, this was a very small study, and the reported data shows scores across multiple time points without a clear breakdown of individual participants or exact visit timing. No comparison group (such as a group without the device) was included in this data submission. 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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NCT04526067 · results posted 5 September 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04526067) enrolled 56 people in total — 35 in a group called R-CAT (a remote version of the programme) and 21 in a group called CAT (Cognitive Adaptation Training, delivered in person). All 56 participants who started the trial completed it. The trial was measuring three main things: how many people dropped out of the programme early, how well participants took their prescribed medication, and how their day-to-day social and work functioning changed over six months. The reported data shows that in the R-CAT group, 4 out of 35 people dropped out of treatment, compared with 3 out of 21 in the CAT group. For medication taking, the reported proportion of prescribed pills taken was 0.21 in the R-CAT group and 0.10 in the CAT group (where a higher number means more pills were taken as prescribed). For day-to-day functioning, the trial used a 0–100 scale where higher scores mean better functioning; the reported change from the start of the trial to six months was a rise of 1.88 points in the R-CAT group and 6.48 points in the CAT group. Two additional measures were also reported: a habit-strength questionnaire (where lower scores indicate stronger habits) showed scores of 6.6 for R-CAT and 7.6 for CAT; and a symptom rating scale (where higher scores mean more severe symptoms) showed a change from baseline of 13.7 for R-CAT and 6.82 for CAT — though it was not reported whether these symptom scores went up or down from the starting point, only that this was the difference. 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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NCT01479829 · results posted 9 April 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 65 people in total — 35 in the intervention group and 30 in the control group. By the end of the study, 27 people in the intervention group and 20 in the control group had completed it, meaning 8 and 10 people respectively did not finish. The trial was measuring two things related to depression symptoms, both assessed using a questionnaire called the Hamilton Depression Rating Scale (HDRS-17). This is a clinician-administered tool where scores range from 0 to 54, with higher scores meaning more severe depression symptoms. The two things being measured were: "response to treatment" (defined as at least a 50% drop in score after 8 weeks) and "remission" (defined as a score below 8 points after 8 weeks). The reported data shows that for "response to treatment," 21 people in the intervention group and 9 people in the control group met the response threshold, while 6 in the intervention group and 11 in the control group did not. For "disease remission," the reported data shows that 17 people in the intervention group and 2 people in the control group reached a score below 8, while 10 in the intervention group and 18 in the control group did not reach 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03573297 · results posted 28 September 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03573297) looked at a medication called cariprazine in people with bipolar disorder. The trial had two main stages. In the first, open-label stage (where everyone knew what they were receiving), 896 people started taking cariprazine and 440 completed it. Those who responded well were then moved into the second, double-blind stage (where neither participants nor doctors knew who was getting which treatment). In that stage, 440 people were randomly assigned to one of three groups: a dummy pill (placebo, 145 people), cariprazine at a lower dose of 1.5 mg daily (144 people), or cariprazine at a higher dose of 3.0 mg daily (147 people). The main thing the trial set out to measure was how long it took for a mood episode — such as a manic or depressive episode — to return (called a "relapse") during the double-blind stage. Relapse was defined using several standard rating scales and clinical judgements. The reported data shows, however, that the specific numbers for time to relapse were listed as "not available" (NA) in the results submitted to ClinicalTrials.gov. This means the actual figures for this primary outcome measure were not reported in the structured data available, so no numbers 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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NCT04276883 · results posted 11 September 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 380 adults across three groups: one group received a 180-microgram dose of the study treatment, another received a 120-microgram dose, and a third received a placebo (an inactive treatment). The trial was measuring changes in agitation levels using a standard rating scale called the PEC (Positive and Negative Syndrome Scale – Excited Component). This scale scores five signs of agitation — such as hostility, tension, and poor impulse control — on a range from 5 (no agitation) to 35 (extremely severe agitation). The vast majority of participants in each group completed the study. The reported data shows that all three groups started with very similar average agitation scores of around 18 out of 35. By the end of the study, the primary outcome measure showed the 180-microgram group's average score had fallen by 10.4 points, the 120-microgram group's by 9.0 points, and the placebo group's by 4.9 points. The reported data also shows how scores changed at earlier time points: at what appears to be the first measurement, the reductions were 3.1, 2.9, and 1.9 points respectively; at a middle point, 4.6, 4.3, and 2.8 points; and at a later point, 6.7, 6.3, and 3.6 points — showing the scores declining over time across all three groups, with the two treatment groups showing larger reductions than the placebo group at each time point measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03208036 · results posted 21 December 2022
According to the results reported on ClinicalTrials.gov, this trial looked at a brain stimulation technique called tDCS (transcranial direct current stimulation) compared to a "sham" (inactive/pretend) version of the same procedure. The trial enrolled 22 people in total — 11 in the tDCS group and 11 in the sham group — though numbers dropped over time due to people not completing each stage. By the final check-in at around five and a half months, 5 people in the tDCS group and 4 in the sham group had completed that stage. The trial was measuring several aspects of memory and thinking, as well as people's ability to carry out everyday tasks and social activities. The reported data shows the following average scores across the two groups at the timepoints measured. For working memory capacity (scored 0 to 1, higher is better), the tDCS group scored around 0.63–0.64 and the sham group around 0.70–0.72 across assessments. For goal maintenance — a part of memory that helps keep track of what you're meant to be doing (scored roughly −4.5 to +4.5, higher is better) — the tDCS group scored between 2.60 and 3.34, while the sham group scored between 2.71 and 2.91. For interference control — the ability to focus without being distracted (scored −3 to +3) — both groups scored slightly below zero across assessments, ranging from −0.03 to −0.37 for tDCS and −0.10 to −0.40 for sham. For everyday functional skills (scored 0–100), the tDCS group scored between 78.33 and 82.00, and the sham group between 73.67 and 77.76. Secondary measures of social functioning (scored 20–80) and performance on untrained memory tasks were also reported, with both groups showing broadly similar scores across 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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NCT02188121 · results posted 22 November 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 204 people in total — 99 in a group that received a statin and/or a blood-pressure-lowering medicine called an angiotensin receptor blocker, and 105 in a "usual treatment" group who received their normal care. The trial was measuring whether people at risk of heart disease were receiving what the researchers defined as adequate cardiovascular prevention care — specifically, whether they were taking both a statin (a cholesterol-lowering medicine) and an angiotensin medication (a blood-pressure medicine). By the end of the study, 79 people in the first group and 78 in the usual-treatment group had completed the trial. The reported data shows that, at the end of the study, 66 out of 99 participants in the statin and/or angiotensin receptor blocker group were recorded as being on what the trial defined as adequate cardiovascular prevention care, compared with 8 out of 105 participants in the usual treatment group. For the secondary outcome — LDL cholesterol levels (a type of cholesterol measured in the blood) — the reported data shows the statin/angiotensin group had an average level of 100 mg/dL at one time point and 86 mg/dL at another, while the usual treatment group had average levels of 106 mg/dL and 100 mg/dL at those same points. Several other planned measurements — including changes in blood pressure, a diabetes-related blood marker (HbA1c), overall cardiovascular risk score, and the number of different heart-related medicines taken — were listed as pre-specified outcomes but no results data was reported for these 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02374476 · results posted 1 November 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 145 patients in an initial phase where an abnormal heart rhythm called ventricular tachycardia (VT — a fast, potentially dangerous heartbeat starting in the lower chambers of the heart) was tested and mapped. After that, 49 patients went into a "Bipolar Ablation" group (a specific catheter-based procedure using two points to deliver energy to the heart to try to correct the abnormal rhythm) and 60 patients were placed in a comparison "Registry" group. The trial's main goal was to measure how many people in each group were free from the return of their VT six months after the procedure. The reported data shows that, at the six-month mark, 16 out of 49 participants in the Bipolar Ablation group and 29 out of 60 participants in the Registry group were recorded as having no return of their VT. On the secondary measurements — things the trial also tracked — the Bipolar Ablation group had 31 recorded procedural complications (events such as death, stroke, heart failure, or other issues occurring around the time of the procedure), compared with 19 in the Registry group. Six participants in the Bipolar Ablation group and 5 in the Registry group showed VT could still be triggered after the procedure. For the Bipolar Ablation group only, the reported average time for the abnormal rhythm to stop during the procedure was about 14 seconds of ablation. Average total procedure time was roughly 342 minutes for the Bipolar Ablation group and 317 minutes for the Registry group. Deaths from any cause were reported for 9 participants in the Bipolar Ablation group and 5 in the Registry 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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NCT02527564 · results posted 6 October 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT02527564) looked at a sleep medicine called suvorexant and measured how it affected total sleep time in people with insomnia. The trial had two phases: a one-week double-blind phase (where neither participants nor researchers knew who was getting the real medicine or a dummy pill called a placebo), and a three-month open-label phase (where everyone knew they were receiving suvorexant). In the double-blind phase, 23 people were assigned to suvorexant and 25 to placebo, with 22 and 24 completing that phase respectively. In the open-label phase, 46 people started and 26 completed it. The reported data shows that the main thing being measured was the change in how much total sleep time people reported themselves getting (using a sleep diary) during the one-week double-blind phase. According to the results reported on ClinicalTrials.gov, people in the suvorexant group reported sleeping an average of about 7.04 hours before the treatment week and about 7.53 hours during it — a reported increase of around 0.49 hours. The placebo group reported sleeping about 7.03 hours beforehand and 7.20 hours during — a reported increase of about 0.17 hours. A separate, device-based measurement of sleep (using a wrist-worn activity monitor called an actigraph) showed a reported increase of about 0.74 hours for the suvorexant group and 0.61 hours for the placebo group over the same period. In the three-month open-label phase, the reported data shows participants' self-reported sleep time was around 7.24 hours at the start and 7.25 hours at three months (a reported change of 0.01 hours), while the device-based measurement showed a reported increase of about 0.88 hours over that same longer period. 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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NCT03156504 · results posted 15 March 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03156504) involved 75 people who received ketamine infusions. One person did not complete the trial, leaving 74 who finished. The study was measuring two things 24 hours after a participant's third ketamine infusion: firstly, how many people reached a score on a depression rating scale (called the MADRS, which runs from 0 meaning no depression to 60 meaning very severe depression) that fell at or below 9, a level the researchers defined as remission; and secondly, how many people saw their scores on a suicidal thoughts rating scale (called the BSS, which runs from 0 to 38, with higher numbers meaning more suicidal thoughts) drop by at least half. The reported data shows that, out of the 75 participants, 39 people had a MADRS depression score of 9 or lower at the 24-hour mark after their third infusion. Separately, 42 people had their suicidal thoughts score fall by 50% or more at that same time point. No other outcome figures were included in the data submitted to ClinicalTrials.gov, so no further numbers can 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02090634 · results posted 27 August 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02090634) involved 58 people in total — 30 in a group that received personalised reminder text messages along with psychoeducation (called iTAB), and 28 in a group that received psychoeducation only (the control group). The trial was measuring how consistently participants took their HIV and psychiatric (psychotropic) medications, using a special electronic bottle cap system (called MEMS) that recorded each time a medication bottle was opened. By the end of the study, 25 people in each group had completed it. The reported data shows that, when looking at the percentage of prescribed doses taken, both groups recorded similar figures: the iTAB group reported 90.3% for HIV medications and 83.9% for psychiatric medications, while the control group reported 90.0% for both. The trial also measured how closely participants took their medications at their intended time, expressed in minutes away from the target dosing time — where a smaller number means more consistent timing. For HIV medications, the iTAB group's reported figure was 27.8 minutes versus 77.0 minutes for the control group. For psychiatric medications, the iTAB group's figure was 46.8 minutes compared to 66.5 minutes for the control group. It is worth noting that these numbers describe what was recorded and reported for this specific group of trial participants only. The reported data shows differences in timing figures between the two groups, but this summary does not draw any conclusions about whether one approach is better than another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02363738 · results posted 28 July 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total — 29 received infliximab (an anti-inflammatory medicine given by drip) and 31 received a saline (salt water) placebo. The trial was looking at people with depression, and the main thing it was measuring was depression symptom severity using a tool called the Montgomery-Åsberg Depression Rating Scale (MADRS), where scores run from 0 to 60 and higher scores mean worse symptoms. The trial checked scores at the start, at 6 weeks, and at 12 weeks. Not everyone finished the trial — 21 people in the infliximab group and 26 in the placebo group completed it. The reported data shows that at the start of the trial, average MADRS scores were similar in both groups — around 29.6 for the infliximab group and 27.8 for the placebo group. At week 6, the infliximab group's average score had dropped to about 19.4, while the placebo group's average was about 20.9. By week 12, the infliximab group's average score was around 18.6, and the placebo group's average was around 16.1. The trial also measured a brain chemical called N-acetylaspartate (a marker sometimes used to look at brain cell health) using a specialised brain scan; the reported data shows those levels were very similar across both groups at both time points (around 5.67–5.81 mmol/kg). Additionally, a scale measuring the ability to feel pleasure (called the SHAPS, scored 14–56 where higher means greater capacity for pleasure) was recorded — at the start, both groups averaged around 34–35, and by the end the infliximab group averaged about 37.2 while the placebo group averaged about 40.8. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03507036 · results posted 3 December 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03507036) enrolled 20 participants in a single treatment group, of whom 15 completed the study and 5 did not. The trial was measuring several physical characteristics of the skin around the knee area, including how loose or textured the skin appeared in photographs, how thick the outer and inner layers of skin were, how much water the skin was losing through its surface, how elastic (stretchy) the skin was, and how blood was flowing through the skin. These measurements were taken at the start of the study (called "baseline") and then again at 7 days, 3 weeks, 3 months, and 6 months after treatment. The reported data shows the following numbers across those time points. For skin laxity (looseness) assessed from photographs, scores of 1.87 and 2.02 were reported on a rating scale (the exact timing of each score was not clearly separated in the submitted data). For the outer skin layer thickness (epidermal thickness), readings in millimetres were: 96.53 at baseline, 106.90 at 7 days, 98.33 at 3 weeks, 92.37 at 3 months, and 91.37 at 6 months. For the deeper skin layer (dermal thickness), the reported figures were: 1104.70 at baseline, 1179.20 at 7 days, 1241.37 at 3 weeks, 1167.93 at 3 months, and 1122.23 at 6 months. Water loss through the skin was measured as 9.38, 9.60, 11.00, 11.74, and 8.77 (in grams per square metre per hour) at those same time points. Skin elasticity readings were 0.80, 0.81, 0.82, 0.77, and 0.75 millimetres respectively. Blood flow at a depth of 0.25 mm was reported as 0.33, 0.23, −0.02, 0.08, and 0.10 millimetres per second across the five 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00961961 · results posted 19 October 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 177 people in its first phase, all of whom received lithium together with fluoxetine (an antidepressant). Of those 177, 51 completed the first phase and went on to a second phase, where they were randomly assigned to continue with either lithium plus fluoxetine (29 people) or lithium plus a placebo — a dummy pill with no active ingredient — (22 people). The trial was measuring whether participants experienced a return of a major depressive episode over the following year, and also whether anyone developed manic or hypomanic episodes (periods of unusually elevated mood or energy). The reported data shows that in the second phase, out of the 29 people taking lithium plus fluoxetine, 4 experienced a relapse of depression within the year. Out of the 22 people taking lithium plus placebo, 5 experienced a relapse. For the secondary outcomes — tracking the onset of manic or hypomanic episodes — the reported data shows zero participants in any group experienced either of those outcomes across both phases of the trial. For a fourth secondary outcome measuring "sub-syndromal mood conversion" (a milder shift in mood that doesn't fully meet the criteria for mania or hypomania), no data was reported. It is worth noting that a large proportion of participants — 126 out of 177 — did not complete the first phase and therefore never entered the second phase, meaning the numbers in the comparison groups were quite 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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NCT01869374 · results posted 19 June 2020
According to the results reported on ClinicalTrials.gov, this trial compared two treatments for depression: Magnetic Seizure Therapy (MST) and Right Unilateral Electroconvulsive Therapy (RUL ECT, a form of electric shock therapy). A total of 18 people took part — 9 in each group. All 9 participants in the MST group completed the trial, while 8 of the 9 in the RUL ECT group completed it (one person did not finish). The trial was measuring changes in depression symptoms using a standard questionnaire called the Hamilton Rating Scale for Depression (24-item version), which gives scores ranging from 0 (no depression) to 75 (most severe). The reported data shows the main result as the average drop in depression scores from the start of the trial to the end of treatment — a bigger drop in score means a greater reduction in reported depression symptoms. For the MST group, the average score dropped by about 22.6 points. For the RUL ECT group, the average score dropped by about 15.4 points. The scale used in this trial categorises scores of 0–7 as no depression, 8–16 as mild, 17–23 as moderate, and 24 and above as severe. No other outcome measures were included in the data reported 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03257865 · results posted 2 January 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03257865) compared brexpiprazole against a placebo (a dummy treatment with no active ingredient) in people experiencing manic symptoms associated with bipolar disorder. A total of 163 people were assigned to the brexpiprazole group and 170 to the placebo group at the start of the trial. Of those, 128 and 135 people respectively completed the study. The trial's main focus was on measuring changes in manic symptoms over three weeks using a standard rating tool called the Young Mania Rating Scale (YMRS), which scores symptoms from 0 (no symptoms) to 60 (most severe). The reported data shows that, after three weeks, the brexpiprazole group's average YMRS score had decreased by 12.3 points from where it started, while the placebo group's average score had decreased by 10.7 points. Both groups showed a reduction in their scores from the beginning of the trial, meaning both groups appeared to have lower recorded manic symptom scores by week three. A secondary measure used a different rating tool called the CGI-BP, which rates overall illness severity on a scale of 1 to 7. The reported data shows the brexpiprazole group's average score on this scale decreased by 1.31 points, compared to a decrease of 1.06 points 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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NCT01811147 · results posted 2 December 2019
According to the results reported on ClinicalTrials.gov, a total of 189 people took part in this study across four groups: 51 in the "High Risk Depression" group, 56 in the "Low Risk Depression" group, 49 in the "Healthy Control" group, and 33 in the "Bipolar" group. The study was measuring depression symptoms and mania (an elevated or overactive mood state) symptoms across these groups, using two standard questionnaire-based rating scales. It is worth noting that the number of participants who completed the study was much smaller than those who started — for example, only 15 of the 51 High Risk Depression participants completed it — which the reported data does not fully explain. The reported data shows that the primary measure was the Hamilton Depression Rating Scale (a 17-question tool scored from 0 to 52, where higher scores indicate more severe depression symptoms). At the end of the study, the average scores reported were 6.6 for the High Risk Depression group, 4.91 for the Low Risk Depression group, 2.33 for the Healthy Control group, and 3.75 for the Bipolar group. According to the scale's own ranges, all four of these average scores fall within the "no depression" band (0–7). The reported data also shows a secondary measure — the Young Mania Rating Scale (scored from 0 to 60, where higher scores indicate more severe manic symptoms). Average scores here were 0.2 for the High Risk Depression group, 0 for both the Low Risk Depression and Healthy Control groups, and 1.75 for the Bipolar group. All of these scores fall within the lowest "in remission/no mania" range of the scale (0–8). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02035202 · results posted 13 August 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 255 people across three groups — 85 in each group. The three groups were: one that used a smartphone app delivering cognitive behavioural therapy (called CBT2go), one that used a smartphone app for mood and symptom tracking only (EMA-only), and one that received standard care without any app. The trial was measuring psychiatric symptom levels, day-to-day functioning in the community, and certain thinking patterns, across several points in time. The reported data shows that for the main measure — a clinician-rated psychiatric symptom scale scored from 24 (lowest/best) to 148 (highest/worst) — all three groups started with scores in the low 40s. Over the course of the trial, the CBT2go group's scores moved from about 43 down to about 40, the EMA-only group's scores moved from about 42 down to about 38, and the standard care group's scores stayed relatively stable, finishing at about 41. For the community functioning measure (scored 30–150, where higher means better functioning), the CBT2go group went from roughly 127 to 130, the EMA-only group stayed around 128–129, and the standard care group edged slightly downward from about 127 to 123. For the thinking patterns scale (scored 40–280, where higher means more unhelpful thought patterns), all three groups started around 49–50, with modest changes across the study period — the reported data does not show any dramatic shifts in any 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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NCT01986101 · results posted 25 July 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01986101) enrolled 525 adults across three groups: 172 received a placebo (a dummy treatment with no active ingredient), 184 received a lower dose of the study drug SM-13496 (20–60 mg per day), and 169 received a higher dose (80–120 mg per day). The trial was measuring changes in depression symptoms in people with bipolar disorder over six weeks, using several rating scales completed by clinicians and participants themselves. Of those who started, 139, 157, and 137 people in each group respectively completed the trial. The reported data shows the main thing being measured was a depression rating scale called the MADRS, which runs from 0 to 60, where a lower score means fewer symptoms. A decrease (negative number) from the starting score is considered a better result. After six weeks, the placebo group's score dropped by an average of 10.6 points, the lower-dose group dropped by 13.6 points, and the higher-dose group dropped by 12.6 points. The reported data also shows results from several secondary scales. On a clinician-rated depression severity scale (CGI-BP-S, scored 1–7), the drops were 1.11 (placebo), 1.51 (lower dose), and 1.41 (higher dose). On a self-rated scale measuring how much symptoms affected daily life (SDS, scored 0–30), the drops were 5.7, 7.6, and 6.8 respectively. Two further scales measuring anxiety symptoms (HAM-A) and manic symptoms (YMRS) also showed score reductions across all three groups, with the placebo group's drops generally being somewhat smaller than those in the two medication 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01059539 · results posted 13 June 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 403 people who were given cariprazine (at doses of 3–12 mg per day) over 16 weeks. The trial was measuring changes in manic symptoms and depressive symptoms in participants over that period. Of the 403 people who started the trial, 132 completed it, while 271 did not finish — meaning the majority of participants left the study before it concluded. The reported data shows that the main thing being measured was a change in a manic symptom score called the YMRS (Young Mania Rating Scale), which runs from 0 to 60, where higher numbers mean more severe manic symptoms. From the start of the trial to week 16, the average score across participants dropped by 15.2 points — a negative change on this scale indicates a reduction in reported symptoms. The trial also measured a depression symptom score called the MADRS (Montgomery-Åsberg Depression Rating Scale), which runs from 0 to 42, where higher numbers mean more severe depressive symptoms. The reported data shows the average score on this scale dropped by 1.6 points over the same period. It is important to note that this trial had only one group — everyone received cariprazine — so there was no comparison group taking a placebo or different treatment reported in this 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01944293 · results posted 6 June 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01944293) enrolled 16 people in total — 7 who received ketamine and 9 who received midazolam (a comparison drug used as an active control). All 16 participants completed the study. The trial was looking at people with bipolar disorder who were going through a major depressive episode and experiencing moderate to severe thoughts of suicide. The main thing being measured was whether those thoughts of suicide changed in the 24 hours after receiving a single infusion (drip through a vein) of either ketamine or the comparison drug midazolam. The reported data shows that suicidal thoughts were tracked using a tool called the Beck Scale for Suicidal Ideation, which produces a numerical score — a lower score indicates fewer suicidal thoughts. The reported results show that, on average, the ketamine group's score dropped by 12.4 points from before the infusion to 24 hours after, while the midazolam group's score dropped by 6.7 points over the same period. The trial also measured changes in systolic blood pressure (the "top number" in a blood pressure reading). The reported data shows the ketamine group's systolic blood pressure rose by an average of 23 millimetres of mercury (mmHg), compared to a rise of 3 mmHg in the midazolam group. It is worth noting that this was a very small study (16 people), and the results as reported on ClinicalTrials.gov reflect only what was measured in this particular 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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NCT02041962 · results posted 16 April 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 238 people in total — 123 in an "Educational Control" group and 115 in a "Chronic Care Model for Mood Disorders" group. The trial was measuring two main things: mental health-related quality of life, and mood disorder symptoms. It is worth noting that a significant number of participants did not complete the full study — by the 12-month follow-up, only 42 people remained in the Educational Control group and 31 in the Chronic Care Model group, out of the 238 who started. The reported data shows the following results at the end of the study. For mental health-related quality of life, participants were scored on a scale of 0 to 100, where a higher number means better quality of life. The Educational Control group scored an average of 38.2, while the Chronic Care Model group scored an average of 43.2. For mood disorder symptoms, participants were scored on a scale of 0 to 27, where a lower number means fewer symptoms. The Educational Control group scored an average of 9.3, and the Chronic Care Model group scored an average of 7.6. The reported data does not include additional statistical detail beyond these average scores. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02204124 · results posted 19 September 2018
According to the results reported on ClinicalTrials.gov, this trial involved 32 people in total who underwent a type of major abdominal surgery called a Whipple procedure (an operation on the pancreas and surrounding organs). Thirteen participants were in the control group, who had the procedure done using standard surgical techniques, while 19 participants had the procedure done using a surgical device called the Thunderbeat™. All 32 participants completed the trial. The trial was measuring things like blood loss during the operation, how long the surgery took, complications that occurred, and costs — comparing the two groups. The reported data shows that the control group had an average estimated blood loss of around 264 mL, while the Thunderbeat™ group had an average of around 480 mL. For post-operative (after-surgery) complications, 7 out of 13 participants in the control group and 8 out of 19 in the Thunderbeat™ group experienced them. Regarding surgery length, the control group averaged 220 minutes and the Thunderbeat™ group averaged 270 minutes. The time participants were under anaesthetic averaged about 283 minutes in the control group and about 357 minutes in the Thunderbeat™ group. During the operation itself, 0 participants in the control group and 3 participants in the Thunderbeat™ group experienced complications such as the need for extra bleeding-control measures or other issues. Cost data was listed as a measure but no figures 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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NCT01898429 · results posted 12 September 2018
According to the results reported on ClinicalTrials.gov, this trial involved 5 participants in total. Each person went through three phases in sequence: 12 weeks with a small brain stimulation device (called deep brain stimulation, or DBS) active on the left side, then 12 weeks with it active on the right side, and finally 12 weeks with it active on both sides. The trial was measuring depression symptoms using a standard questionnaire called the Hamilton Depression Rating Scale (a 17-item version, scored from 0 to 48, where higher scores mean more severe depression and a score of 7 or below is considered remission). The reported data shows four scores on this scale across the participant group: 22.35, 18.8, 21.4, and 17.4. Based on the trial's description, these appear to represent average scores at different time points — before surgery and at various stages of stimulation — though the data as submitted does not clearly label which number corresponds to which exact time point or phase. All four figures sit well above the remission threshold of 7. The data was not reported in a way that allows a straightforward side-by-side comparison of left-sided versus right-sided stimulation scores to be described with confidence. It is worth noting that with only 5 participants, this was a very small study, likely designed to explore how the procedure works rather than draw broad conclusions. The reported data shows what was measured in this specific group of people, and no conclusions about the treatment more generally 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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NCT00183443 · results posted 17 July 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 75 people in total, divided into three groups: 24 people received divalproex (DVP) plus a placebo, 26 received DVP plus quetiapine, and 25 received DVP plus lithium. All 75 participants completed the study — none dropped out. The trial was primarily looking at symptoms of mania using a questionnaire called the Young Mania Rating Scale (YMRS), which runs from 0 to 60, where higher scores mean more severe manic symptoms. It also measured depression severity, overall illness severity, and how well participants were functioning day-to-day, using several different rating scales. The reported data shows that at the end of the study, the average YMRS mania score was 5.7 for the DVP plus placebo group, 11.1 for the DVP plus quetiapine group, and 10.0 for the DVP plus lithium group. For depression (measured on a 0–50 scale where higher means more severe), the reported averages were 13.2, 18.3, and 18.8 for the three groups respectively. On the illness severity scale (rated 1 to 7, where higher means more unwell), the reported averages were 1.58, 2.54, and 2.32. For day-to-day functioning (scored 0–100, where higher means better functioning), the results reported were 68.3, 62.3, and 60.8 on one scale, and 68.2, 62.1, and 59.8 on a second similar scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01396447 · results posted 1 May 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 584 adults across four groups to study the effects of different doses of a medication called cariprazine on depression symptoms. Participants were randomly assigned to receive either a placebo (a dummy pill with no active ingredient) or one of three doses of cariprazine — 0.75 mg, 1.5 mg, or 3.0 mg — and were followed for six weeks. The trial measured changes in depression using two rating scales completed by clinicians. The reported data shows that the main thing being measured was a depression rating scale called the MADRS, which runs from 0 to 60, where a higher score means more severe depression and a drop in score suggests fewer symptoms. At the six-week mark, the placebo group's average score fell by 11.1 points from where it started. The reported drops for the cariprazine groups were 13.0 points for the 0.75 mg group, 15.1 points for the 1.5 mg group, and 13.7 points for the 3.0 mg group. A second scale measuring overall illness severity (rated 1 to 7, with higher meaning more severe) also showed score reductions: the placebo group dropped by 1.0 point, while the cariprazine groups dropped by 1.1, 1.4, and 1.3 points respectively. Regarding completion, out of those who received treatment, 105 placebo participants, 103 in the 0.75 mg group, 117 in the 1.5 mg group, and 94 in the 3.0 mg group finished the full six weeks; the data does not report reasons for non-completion in detail. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01615367 · results posted 27 April 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 38 people in total — 19 in a group receiving a new treatment (called "NEW Tx") and 19 in a group receiving their usual care ("Treatment as Usual" or TAU). Of those who started, 14 in the NEW Tx group and 13 in the TAU group completed the study. The trial was primarily measuring how acceptable and satisfying participants found the new treatment, using two questionnaires filled out at around 20 weeks. The reported data shows that on the NEW Tx Scale — where lower scores indicate a more positive view of the treatment (scores range from 10 to 50) — the NEW Tx group scored an average of 23.54, while TAU participants who later tried the new treatment scored 37.75. On the Client Satisfaction Questionnaire — where higher scores indicate greater satisfaction (scores range from 8 to 32) — the NEW Tx group averaged 25.77, compared to 23.13 for the TAU group. For the secondary measures, the reported data shows average scores for day-to-day functioning, depression symptoms, and mania symptoms were broadly similar between the two groups. Average Body Mass Index was reported as 32.49 kg/m² for the NEW Tx group and 35.76 kg/m² for the TAU group. It is worth noting that these are average scores at a single point in time as reported, 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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NCT01775722 · results posted 9 April 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 22 adults or participants who received a combined radio frequency and pulsed dye laser treatment for port wine stains — a type of birthmark caused by abnormal blood vessels in the skin. Twenty participants completed the study, while two did not finish. The trial was measuring how much the port wine stain "blanched" (lightened in colour) after treatment, by comparing the amount of blood in the skin before and eight weeks after treatment. The reported data shows that the primary outcome was a measure called "percent change in blanching," which reflects how much the birthmark lightened. According to the results reported on ClinicalTrials.gov, the group receiving the combined radio frequency and pulsed dye laser treatment had a reported blanching score of 5%, while a comparison group receiving pulsed dye laser treatment only had a reported blanching score of 6%. No secondary outcome measure data appears to have been 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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NCT00732251 · results posted 22 February 2018
According to the results reported on ClinicalTrials.gov, this trial looked at allopurinol as a treatment for people with bipolar disorder. Eight people started the study, but only one completed it — seven participants left before the study finished. Because so few people completed the trial, the results should be read with that limitation in mind. The study was measuring mood symptoms using two standard rating tools: one for manic (high/elevated mood) episodes and one for depressive (low mood) episodes, as well as tracking any hospital stays for psychiatric reasons. The reported data shows that, across all patient visits, there were 3 visits where a participant's score on the mania rating scale indicated a manic episode, and 7 visits where a participant's score on the depression scale (a score of 11 or more) indicated a depressive episode. These are counts of visits, not individual people. For the third outcome — the number of psychiatric hospital stays during the study compared to before it — the reported data shows no figures were submitted, so those results 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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NCT00619723 · results posted 24 January 2018
According to the results reported on ClinicalTrials.gov, this trial looked at a supplement called citicoline compared to a dummy pill (placebo) in people who use cocaine. A total of 130 people joined the study — 63 in the citicoline group and 67 in the placebo group. Over 12 weeks, participants provided urine samples three times a week to check for cocaine use. The trial also measured mood-related symptoms, specifically signs of depression and mania (an elevated or overactive mood state), using two standard rating scales completed with a clinician. The reported data shows that, when looking at urine screens that tested positive for cocaine across the 12 weeks, 59% of results in the citicoline group were positive, compared to 49.2% in the placebo group. For depression symptoms, both groups scored similarly on the rating scale (where higher numbers mean more severe symptoms and the scale runs from 0 to 52) — the citicoline group averaged 17.9 and the placebo group averaged 18.0. For manic symptoms (measured on a scale from 0 to 60, where higher means more severe), the citicoline group averaged 10.2 and the placebo group averaged 10.1. The reported data does not include any further breakdown of these figures beyond what is 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01410357 · results posted 4 October 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 200 people with serious mental illness — 100 in each group. One group received a structured programme called Targeted Training in Illness Management (TTIM), while the other group received Treatment As Usual (TAU), meaning the standard care they would normally get. The trial measured several things at 60 weeks (about 15 months), including levels of psychiatric symptoms, depression, overall illness severity, day-to-day functioning, disability, and self-rated mental health. Of the 200 who started, 74 in the TTIM group and 76 in the TAU group completed the study. The reported data shows the following scores at 60 weeks across the six main measures. On the psychiatric symptom scale (scores 7–126, where higher means more severe symptoms), the TTIM group scored 32.04 and the TAU group scored 35.89. On the depression scale (scores 0–60, higher meaning worse depression), TTIM scored 15.92 versus 18.55 for TAU. On the overall illness severity rating (scores 0–7, higher meaning more severe), TTIM scored 3.24 versus 4.03 for TAU. On the general functioning scale (scores 1–100, where higher means better functioning), TTIM scored 61.05 versus 53.29 for TAU. On the disability scale (scores 0–30, higher meaning greater disability), TTIM scored 15.0 versus 16.47 for TAU. Finally, on the self-reported mental health component of a general health survey (where 50 represents the average in the general population), TTIM scored 42.05 versus 39.58 for TAU. The reported data shows that, across all six measures, the TTIM group's scores sat in a direction that would indicate fewer symptoms or better functioning compared to the TAU group, though this summary only describes the numbers as reported and does not draw any conclusions about what caused these differences or how meaningful they are. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00338806 · results posted 15 August 2017
According to the results reported on ClinicalTrials.gov, this trial compared two approaches for young people at risk of depression: one called Interpersonal Psychotherapy for Prevention (a type of talk therapy focused on relationships) and one called Educational Clinical Monitoring (a more standard monitoring and education approach). The trial ran in two phases — an acute (active treatment) phase and a follow-up period. In the acute phase, 2 participants were in the therapy group and 5 were in the monitoring group. By the follow-up phase, only 1 person in the therapy group and 1 in the monitoring group completed the study. These are very small numbers, which the trial itself appears to reflect — this was likely a pilot or feasibility study rather than a large-scale trial. The reported data shows results on two main measuring tools. The first was a structured interview (called the KSADS-P) used to count how many participants showed signs of a current psychiatric episode — such as a mood or anxiety disorder — at various points during the trial. The numbers of participants flagged at different time points were very small (ranging from 0 to 2 people in any given group at any given point), which reflects the tiny overall sample size. The second tool was a depression severity rating scale for children and adolescents (called the CDRS-R), scored from 17 to 113, where lower scores mean fewer signs of depression and scores above 41 suggest at least mild-to-moderate depression. The reported data shows average scores in the therapy group of around 26–26.5, and in the monitoring group of around 28.75–29.5, both of which fall below the 41-point threshold used to indicate mild-to-moderate depression. Because so few people took part and so many did not complete the study, the reported numbers are very limited in what they can show. 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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NCT01929681 · results posted 27 June 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 53 adults in total — 28 in the active treatment group (receiving Low Field Magnetic Stimulation, or LFMS) and 25 in a sham (inactive/pretend) treatment group. The trial was measuring changes in depression symptoms and mood over a short period involving three treatment sessions. The main tools used were the Montgomery-Åsberg Depression Rating Scale (MADRS) — a structured interview where a higher score means more severe depression symptoms, scored out of 60 — and the Positive and Negative Affect Schedule (PANAS), a self-rated mood questionnaire scored from 10 to 50 for positive feelings and separately for negative feelings. The reported data shows that, for the primary depression measure (MADRS), scores in the active treatment group dropped by an average of 14.03 points from before treatment to a follow-up visit seven days after the first session, while scores in the sham group dropped by an average of 9.75 points over the same period. For the other primary measure — immediate change in positive mood (PANAS positive subscale) right before versus right after the very first treatment — the active group showed an average change of +0.5 points, while the sham group showed an average change of +1.4 points. For the secondary measures tracking how scores shifted across all three treatment days, the reported data shows relatively small numerical differences between the two groups in both depression and mood ratings, with figures 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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NCT01892306 · results posted 12 May 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01892306) involved 29 people in total — 13 in a group that received their usual psychiatric care plus an additional talking therapy called the Unified Protocol (UP CBT), and 16 who received usual care alone. The trial was measuring changes over time in anxiety and depression symptoms, as well as how satisfied participants were with their treatment, and whether certain thinking and emotional patterns were linked to any changes in anxiety symptoms. Of the 29 who started, 18 finished the study (8 in the combined therapy group and 10 in the usual care group). The reported data shows that anxiety symptoms, measured on the Hamilton Anxiety Rating Scale (a clinician-rated scale from 0 to 56 where higher numbers mean more severe symptoms), were recorded at multiple points across the study. Across those time points, the combined therapy group's scores ranged from around 10 to 15.7, while the usual care group's scores ranged from around 17.7 to 22.3. For depression symptoms, measured on a similar clinician-rated scale (0 to 54), the combined therapy group's scores ranged from roughly 8 to 11.9, compared with roughly 11.2 to 16.9 in the usual care group. Treatment satisfaction scores (on a scale of 8 to 32, where higher means more satisfied) were reported across multiple time points, with the combined therapy group scoring between approximately 28 and 29.8, and the usual care group between approximately 26.2 and 27.3. The reported data also shows figures described as "beta coefficients" — a statistical measure of the relationship between two things — linking changes in anxiety symptoms to scores on three separate questionnaires about emotion regulation, reactions to emotions, and anxiety sensitivity. For the combined therapy group, these figures were 0.759, 0.766, and 0.371 respectively, compared with 0.180, 0.022, and 0.062 for the usual care group. The trial data does not include further explanation of what these specific numbers mean in practical terms. 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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NCT01979133 · results posted 19 April 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01979133) involved 10 people who were given a treatment called Icariin. Seven participants completed the study, while three did not finish. The trial was measuring changes over 8 weeks in two areas: mood (specifically symptoms of depression and anxiety) and alcohol use (including how many drinks per week, how many days involved heavy drinking, and how many days any alcohol was consumed at all). The reported data shows the following changes from the start of the trial (baseline) to week 8. For depression, as measured by a clinician-rated scale (the HAMD, scored 0–52 where higher means more severe), the average score went from 17.5 at the start to 9.0 at week 8. On a self-reported depression scale (the QIDS, scored 0–27), scores went from 11.8 down to 5.7. For anxiety, measured on a 0–56 scale where higher means more severe, the average score went from 15.2 to 4.6. Regarding alcohol use, the reported average number of standard drinks per week went from 38.8 at the start to 10.3 at week 8. The average number of heavy drinking days per week went from 3.2 to 1.2, and the number of days per week any alcohol was consumed went from 4.1 to 3.3. It is important to note that this was a very small study with only 10 participants and no comparison group, which means the numbers above reflect what was observed in this particular 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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NCT01058096 · results posted 17 April 2017
According to the results reported on ClinicalTrials.gov, this trial looked at a medication called cariprazine compared to a placebo (a dummy treatment with no active ingredient) in people experiencing manic episodes. A total of 154 people were assigned to the placebo group and 158 to the cariprazine group during the main treatment phase. The trial ran for three weeks, and the main thing it was measuring was how scores on a manic symptoms rating scale — called the Young Mania Rating Scale (YMRS) — changed from the start of the trial to the end of week three. This scale runs from 0 (no symptoms) to 60 (most severe), and a lower score means fewer symptoms. The reported data shows that, on average, YMRS scores fell by 15.3 points in the placebo group and by 19.6 points in the cariprazine group over the three weeks. The trial also measured a second scale called the Clinical Global Impression-Severity (CGI-S), where a doctor rates how unwell a person appears overall on a 1-to-7 scale. The reported data shows that CGI-S scores dropped by an average of 1.3 points in the placebo group and 1.6 points in the cariprazine group by week three. Both groups showed a decrease (that is, movement toward lower scores) on both measures, with the cariprazine group showing a somewhat larger decrease in each case. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00360126 · results posted 30 March 2017
According to the results reported on ClinicalTrials.gov, this trial involved 11 participants, all of whom received the study drug lamotrigine. All 11 participants completed the study, with none dropping out. This appears to have been an extension study — meaning it followed on from an earlier trial — and it focused specifically on tracking serious adverse events (SAEs). An SAE is defined as an unexpected medical problem that results in death, is life-threatening, requires a hospital stay, causes lasting disability, or involves a birth defect. The reported data shows that out of the 11 participants, zero experienced a serious adverse event during the course of the study. It is worth noting that, according to the study description, only serious adverse events were recorded and reported in this extension study — so information about less severe or minor side effects was not collected or submitted as part of these 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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NCT00562861 · results posted 13 February 2017
According to the results reported on ClinicalTrials.gov, this trial involved 119 people in total — 60 who received a mood stabiliser combined with citalopram (an antidepressant), and 59 who received a mood stabiliser combined with a placebo (a dummy pill with no active ingredient). The trial was measuring changes in depression symptoms over time using a standard rating tool called the Montgomery Åsberg Depression Rating Scale, or MADRS — a questionnaire scored from 0 to 60, where higher scores indicate more severe depression symptoms. Not everyone finished the trial: 40 out of 60 completed it in the citalopram group, and 48 out of 59 completed it in the placebo group. The reported data shows that both groups had a reduction in their MADRS depression scores over the course of the trial. The way the results are presented, a higher change number means a greater improvement in depressive symptoms. The group taking citalopram alongside a mood stabiliser showed an average change of 13.1 points on the scale, while the group taking the placebo alongside a mood stabiliser showed an average change of 15.2 points. No other outcome measures were included in the data submitted to ClinicalTrials.gov. It is worth noting that only one outcome measure was reported in the submitted data, and no additional detail — such as side effects or other assessments — was included in what was provided. The reported data shows only these two numbers for the primary depression scale, and nothing further was available to summarise. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01786239 · results posted 1 February 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01786239) involved 50 people in total, split evenly into two groups of 25. One group took omega-3 capsules alongside the medication risperidone, while the other group took a placebo (a dummy capsule containing soybean and corn oil) alongside risperidone. The trial was measuring psychiatric symptoms using a tool called the Brief Psychiatric Rating Scale (BPRS) — a scoring system that runs from 0 to 126, where a higher number means more symptoms are being reported. The reported data shows that at the start of the trial, both groups had similar average BPRS scores — around 41.6 for the omega-3 plus risperidone group, and around 42.4 for the placebo plus risperidone group. By the end of the study, the reported average scores had dropped in both groups — to approximately 22.6 for the omega-3 group and approximately 27.2 for the placebo group. It is worth noting that of the 25 people who started in each group, only 14 in each group completed the trial, meaning 11 people in each group did not finish. The reported data does not include any further breakdown of why participants left the trial early, and no additional outcome measures were 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01602510 · results posted 23 January 2017
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called lamotrigine (at a dose of 200 mg per day) in people with bipolar disorder. The trial had two stages. In the first open-label stage — where everyone knew they were receiving lamotrigine — 420 people started, but only 117 completed it and moved on. In the second randomised stage — where neither participants nor investigators knew who was getting what — 133 people were assigned to a placebo (a dummy treatment with no active ingredient) and 131 were assigned to lamotrigine. Of those, 59 and 58 people respectively completed this second stage. The reported data shows that the main thing the trial was measuring was how long it took before a doctor needed to prescribe extra medication or a treatment called ECT (a procedure using electrical stimulation) to manage a return of mood symptoms such as depression, mania, or mixed episodes. According to the results reported on ClinicalTrials.gov, the numerical results for this primary measure — and for two related secondary measures looking specifically at depressive episodes and manic/hypomanic/mixed episodes separately — were listed as "not available" (NA), meaning those specific figures were not reported in the submitted data. For a broader measure of overall time spent in the study before needing extra treatment or dropping out, the reported median was 183 days for the placebo group and 188 days for the lamotrigine group. Two rating scales used by clinicians to assess illness severity and change over time showed small reported differences between groups, but these figures were not reported for every individual time point. The reported data also shows that a large proportion of participants did not complete each stage of the trial, which the investigators accounted for in their analysis. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01841970 · results posted 16 January 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01841970) enrolled 20 participants in a single group called the "HET Arm," which refers to a procedure being studied as a treatment for haemorrhoid symptoms such as bleeding and prolapse (where the haemorrhoid slips out of position). The trial tracked whether participants' symptoms resolved after the procedure, and also followed them up at one month, three months, and six months to check for any return of symptoms or pain. Of the 20 people who started the trial, 9 completed it and 11 did not complete it — the reasons for not completing were not detailed in the reported data. The reported data shows that out of 20 participants, 18 were recorded as having their symptoms resolve following the procedure. When looking at whether pre-procedure symptoms came back after initially improving, the reported data shows that at the one-month follow-up, 0 participants had a recurrence; at three months, 3 participants had a recurrence; and at six months, 4 participants had a recurrence. For pain — measured on a 0-to-10 scale where 0 means no pain and 10 means the worst pain imaginable — the reported average (mean) scores were 0.7 at one month, 0.4 at three months, and 0.1 at six months. The reported data also shows that the number of participants reporting any pain at all was 4 at one month, 1 at three months, and 1 at six months. Regarding complications such as external blood clots, infection, or delayed healing after the procedure, the reported data shows that across all follow-up time points (one, three, and six months), zero participants were recorded as experiencing any of those specific complications. It is worth noting that the number of participants still being followed up reduced over time — 18 at one month, 11 at three months, and 9 at six months — so the later figures reflect a smaller 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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NCT01567943 · results posted 5 January 2017
According to the results reported on ClinicalTrials.gov, this trial involved 123 people in total across three groups. Forty people were placed in a "Contingency Management" group, 39 were in a "Non-contingent Control Group," and 44 people dropped out before being randomly assigned to either group. The trial was measuring alcohol use — detected through a urine test that looks for a substance called ethyl glucuronide (EtG), which is a marker left in the body after drinking alcohol. A reading of 150 nanograms per millilitre (ng/mL) or above was considered a positive result for recent alcohol use. The trial also looked at how often participants attended an outpatient substance use treatment programme. The reported data shows that, on average, the Contingency Management group had a mean urine EtG reading of 408.86 ng/mL, while the Non-contingent Control Group had a mean reading of 734.79 ng/mL. Both of these average figures sit above the 150 ng/mL threshold used in the study. For treatment attendance, the reported data shows the Contingency Management group attended approximately 57% of their scheduled sessions, compared with 53% for the Non-contingent Control Group. Several other things were planned to be measured — including self-reported drug use, other drug use from urine tests, community outcomes (such as jail bookings and emergency department visits), and mental health symptoms — however, no numerical results for those outcomes 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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NCT00566111 · results posted 19 October 2016
According to the results reported on ClinicalTrials.gov, this trial looked at whether ceftriaxone (an antibiotic) compared to a placebo (an inactive "dummy" treatment) might have any effect on symptoms of depression. A very small number of people took part — just 2 people in the ceftriaxone group and 3 in the placebo group. Of those, both participants in the ceftriaxone group completed the trial, while only 1 out of 3 in the placebo group finished (2 did not complete it). The trial measured changes in depression symptoms using several standard rating scales over four weeks. The reported data shows the following numbers for the primary outcome — a scale called the Hamilton Depression Rating Scale (HDRS), which rates depression symptoms: 2 out of 2 participants in the ceftriaxone group and 1 out of 1 completing participant in the placebo group showed a decrease in their scores at four weeks. For a secondary measure called the MADRS (another depression symptom scale), 2 out of 2 in the ceftriaxone group showed a decrease, compared to 0 out of 1 in the placebo group. On the CGI-BP scale (a clinician's overall impression scale), 2 out of 2 in the ceftriaxone group and 1 out of 1 in the placebo group showed a decrease. No participants in either group met the threshold for full remission (a very low HDRS score). The reported data for the QIDS scale (a self-reported depression symptom measure) was not reported in the submitted results. It is worth noting that with only 5 participants total — and even fewer completing the trial — the numbers here are extremely small, meaning no broad conclusions can be drawn from them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00596622 · results posted 17 October 2016
According to the results reported on ClinicalTrials.gov, 46 people with bipolar disorder took part in this trial, all of whom were treated with lithium. Of those, 33 completed the trial and 13 did not finish. The trial was measuring two things: depression levels (using a 17-item questionnaire called the Hamilton Depression Rating Scale, or HDRS, scored from 0 to 52 where higher scores mean more severe depression) and mania levels (using the Young Mania Rating Scale, scored from 0 to 60 where higher scores mean more severe mania). Participants were grouped into three categories depending on their mood state at the start: depressed, manic, or euthymic (meaning their mood was relatively stable). The reported data shows the following HDRS (depression) scores. At the start, the depressed group scored 20 (which falls in the severe range on this scale), the manic group scored 6, and the euthymic group scored 6. Later measurement points showed scores of 2, 3, and 2 for those same groups respectively. For the mania scale, the reported data shows starting scores of 15 (mild-to-moderate mania range) for the manic group, 3 for the depressed group, and 1 for the euthymic group, with later scores of 3, 2, and 2 for those groups. It is worth noting that the data as submitted does not clearly label which measurements correspond to which specific time points, so the exact timing of these scores was not reported in a way that allows further detail to 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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NCT01358357 · results posted 26 July 2016
According to the results reported on ClinicalTrials.gov, this trial looked at a medication called lurasidone (at a flexible dose of 20–80 mg per day) compared to a placebo (an inactive dummy pill) in people with bipolar disorder. The trial had two phases: an initial open-label phase (where everyone knew what was being given) in which 965 people started and 503 completed it, followed by a double-blind phase (where neither participants nor researchers knew who was getting which treatment) in which 246 people received lurasidone and 250 received placebo. The main thing being measured was how long it took before participants experienced a return of a mood episode — such as a manic or depressive episode — during the double-blind phase. The reported data shows that for the primary outcome — time until a mood episode returned — a specific number of days was not reported for the lurasidone group (shown as "NA," meaning the data was not available in the submission), while the placebo group had a reported figure of 207 days. For the percentage of participants who experienced a return of a mood episode, the reported data shows 16.7% in the lurasidone group and 21.6% in the placebo group. The time until participants stopped the trial for any reason was reported as 225 days for the lurasidone group and 207 days for the placebo group. Two clinician-rated illness severity scores (rated on a 1–7 scale, where higher means more severe) were also measured; changes from the start of the double-blind phase to week 28 were reported as small increases in both groups, with the lurasidone group showing a change of 0.40 (overall severity) and 0.10 (mania severity), compared with 0.49 and 0.21 respectively in the placebo group. For the secondary outcome measuring time to recurrence of a specific mood episode type, no figures were reported for either 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT00665444 · results posted 12 February 2016
According to the results reported on ClinicalTrials.gov, this trial looked at a single group of participants taking aripiprazole (a medication used for certain mental health conditions). The study was measuring things like sleep and wake patterns, physical activity levels, daytime sleepiness, and broader wellbeing — including mood, quality of life, and day-to-day functioning. Only 3 people started the trial, 1 person completed it, and 2 did not finish. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — neither the primary ones (such as the sleep/activity monitor readings and the daytime sleepiness scale) nor the secondary ones (such as the mood, functioning, and quality of life questionnaires). Because the data was not reported, it is not possible to describe what the measurements showed. It is worth noting that with only 3 participants enrolled and just 1 completing the trial, this was an extremely small study, and the absence of reported results means very little can be drawn from it. 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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NCT01256177 · results posted 3 February 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 148 people in a placebo group and 148 people in a Quetiapine XR (an extended-release medication) group, giving a total of 296 participants. The trial ran for 8 weeks and was primarily measuring changes in depression symptoms in people with bipolar disorder, using a standard rating scale called the MADRS (Montgomery-Åsberg Depression Rating Scale). On this scale, scores run from 0 to 60, where a higher number means more severe symptoms. By the end of the trial, 98 people in the placebo group and 111 people in the Quetiapine XR group had completed the full 8 weeks. The reported data shows that, on average, participants in the placebo group started with a MADRS score of around 28.8 and saw it fall by about 15.3 points by week 8. Participants in the Quetiapine XR group started with a similar average score of around 28.5 and saw it fall by about 18.5 points over the same period. For two secondary measures, the reported data shows that 62 out of 148 placebo participants and 93 out of 148 Quetiapine XR participants had their MADRS score drop by at least half from where it started — a threshold the researchers called a "response." Separately, 59 placebo participants and 88 Quetiapine XR participants reached a MADRS score of 12 or below by week 8, which the researchers defined as "remission" (meaning very low symptom levels on this scale). Other secondary scales measuring depression and overall illness severity also showed score reductions in both groups across the 8 weeks, with the specific numbers for each time point included in the full trial record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01259427 · results posted 28 January 2016
According to the results reported on ClinicalTrials.gov, this trial involved 248 people in total — 124 in a group called "Ending Self Stigma" and 124 in a comparison group called "Health and Wellness." Both groups were made up of people living with serious mental illness. The trial was measuring several things: how much participants felt negatively about themselves because of their mental illness (called internalised stigma), their sense of personal recovery, their confidence in handling everyday challenges (self-efficacy), their sense of belonging, their satisfaction with life, and how socially engaged they were. By the end of the study, 106 people in the Ending Self Stigma group and 110 in the Health and Wellness group had completed the trial. The reported data shows that scores at the end of the study were very similar between the two groups across all measures. For internalised stigma (scored 1–4, where higher means more stigma), both groups scored 2.1 at the end. For personal recovery (scored 25–125, where higher means greater recovery), the Ending Self Stigma group scored 96.7 and the Health and Wellness group scored 97.3. For self-confidence in everyday tasks (scored 1–5), both groups scored 3.6 and 3.7 respectively. For sense of belonging, scores were also closely matched between the two groups. On the secondary measures, life satisfaction (scored 1–7) was 4.6 versus 4.7, and social engagement (scored 0–15) was 9.7 versus 10.0 at the end of the study. The reported data shows that, across all of these measures, the scores at the end of the study were close to where they started and were broadly similar between the two groups, with no large numerical differences reported between them. It is worth noting that the data as submitted does not clearly label which sets of numbers represent the starting point and which represent the end point, so a direct before-and-after comparison cannot be stated with certainty 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00566150 · results posted 2 November 2015
According to the results reported on ClinicalTrials.gov, this trial looked at whether levetiracetam (a medication more commonly used for epilepsy) might reduce symptoms of depression in people with bipolar disorder. A total of 35 people took part — 19 were given levetiracetam and 16 were given a placebo (a dummy treatment with no active ingredient). Of those, 10 in the levetiracetam group and 11 in the placebo group completed the trial. The main thing being measured was how much participants' scores changed on a standard depression questionnaire called the Hamilton Depression Rating Scale (HDRS-21), where a higher score means more severe depression symptoms. The reported data shows that, by week 6, both groups had lower (improved) depression scores compared to where they started. In the levetiracetam group, the reported change in HDRS-21 score at week 6 was approximately −4.8 points, while in the placebo group it was approximately −7.1 points — meaning the placebo group's scores dropped by a larger amount. A secondary measure called the MADRS (another depression rating scale) showed a similar pattern across the study period, with varying changes reported at different time points for each group. On another secondary measure — the number of people whose scores fell low enough to be considered "in remission" (an HDRS-21 score of 7 or below) — the reported data shows 0 out of 19 in the levetiracetam group reached that threshold, compared with 4 out of 16 in the placebo group, based on one analysis method. A separate count (using a different statistical approach) reported 17 out of 19 versus 11 out of 16. A clinician-rated scale (CGI-BP) also showed score reductions in both groups, with the placebo group again showing slightly larger reported reductions at most 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01674010 · results posted 12 October 2015
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called ELND005 (taken twice daily at a dose of 500 mg) in people with bipolar disorder. The trial was designed in two parts: an open phase where everyone received the drug, followed by a randomised phase where participants were split into two groups — one continuing on ELND005 and one switched to a placebo (a dummy treatment with no active ingredient). A total of 309 people started the open first phase, and 129 of them completed it. From those, 129 went into the second phase, with 65 assigned to placebo and 64 continuing on ELND005. However, the trial was terminated early, meaning it was stopped before it was originally planned to finish. The reported data shows that because the trial ended early, no analysis was carried out on whether the drug had any effect on the trial's main goals — such as preventing mood episodes from returning. The only results reported were counts of "treatment emergent adverse events," which means any unwanted health events that occurred during the study period. In the open first phase, 153 out of 309 participants had at least one such event reported. In the second phase, 45 out of 65 participants in the placebo group and 45 out of 64 in the ELND005 group had at least one such event reported. The reported data shows that no numbers were provided for any of the secondary outcomes — including the proportion of people who experienced a return of any mood episode, or the time it took for a depressive or manic episode to return. The ClinicalTrials.gov record states that no efficacy analysis was conducted due to the early termination of the trial, so those 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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NCT00176228 · results posted 30 July 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 48 participants, all of whom received the medication lamotrigine. Of those, 46 completed the study and 2 did not. The trial was measuring symptoms of mania and depression in participants over a period of 14 weeks, using two standard rating scales — one for mania (the Young Mania Rating Scale, or YMRS) and one for depression in children (the Child Depression Rating Scale, or CDRS-R). Both scales work by assigning scores based on the severity of symptoms, where higher numbers indicate more severe symptoms. The reported data shows that on the mania scale (YMRS), where scores range from 0 to 60 and a score of 12 or above indicates significant symptoms, participants had an average score of 19.61 at the start of the study. By week 8, the average score had dropped to 7.06, and by week 14 it was 5.68. On the depression scale (CDRS-R), where scores range from 18 (no symptoms) to 120 (most severe), the average starting score was 52. By week 8 this had fallen to 31.39, and by week 14 it was 26.10. These are the numbers as submitted; the trial did not include a comparison group receiving a different treatment or a placebo, so these figures reflect changes within a single group of participants 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00790738 · results posted 2 July 2015
According to the results reported on ClinicalTrials.gov, this trial compared a thyroid hormone medication called liothyronine (also known as T3) against a placebo (an inactive dummy treatment) in people with depression. A total of 11 people were enrolled — 5 in the T3 group and 6 in the placebo group. By the end of the trial, only 3 people in each group had completed it, meaning 2 people dropped out of the T3 group and 3 dropped out of the placebo group. The trial was measuring the severity of depressive and manic symptoms using standard rating scales completed by clinicians. The reported data shows the following average scores at the end of the study. On the Hamilton Rating Scale for Depression — a checklist where higher scores mean more severe depression (0–50 scale) — the T3 group scored an average of 3.5 and the placebo group scored 7.25, both of which fall in the "normal" range on that scale (7 or below). On the Clinician-Administered Rating Scale for Mania — which measures manic symptoms (0–50 scale, where 7 or below is considered normal) — the T3 group averaged 0.5 and the placebo group averaged 2, both also in the normal range. On the Clinical Global Impression scale — a 1-to-7 rating of overall illness severity where 1 is "not at all ill" and 7 is "extremely ill" — the T3 group averaged a score of 4 ("moderately ill") and the placebo group averaged 3 ("mildly ill"). It is worth noting that only 6 people in total finished the trial, which is a very small number, and the reported data reflects only those who completed it. Because so few people took part, these numbers should be interpreted with great caution and cannot be taken as a broad conclusion about the treatment. 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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NCT00960375 · results posted 23 June 2015
According to the results reported on ClinicalTrials.gov, this trial involved two groups of people who smoke, comparing two different stop-smoking support approaches — one called BTSCS and the other called StSST. A total of 92 people started in the BTSCS group and 87 in the StSST group. Of those, 72 and 65 people respectively completed the study. The trial measured two main things: how many cigarettes participants were smoking per day near the end of the study, and how many participants reported having stopped smoking entirely (confirmed by a breath test showing very low levels of carbon monoxide, a marker of recent smoking). The reported data shows that, on average, people in the BTSCS group were smoking about 15.4 cigarettes per day, while those in the StSST group were smoking about 14.9 cigarettes per day. When it came to stopping smoking altogether, the reported data shows that 10 participants in the BTSCS group and 6 participants in the StSST group met the criteria for abstinence — meaning they both reported not smoking and had a breath test result below the set threshold. No other outcome measures were 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01195363 · results posted 12 February 2015
According to the results reported on ClinicalTrials.gov, this trial looked at a medication called quetiapine SR (a slow-release tablet) compared to a placebo (a dummy tablet with no active ingredient) in people experiencing mood episodes. A total of 28 people were enrolled — 15 in the quetiapine SR group and 13 in the placebo group. The trial measured whether participants' mood improved, using two standard rating scales: one for depression (the MADRS) and one for mania (the YMRS). Both scales run from 0 (no symptoms) to 60 (most severe symptoms), and "improvement" was defined as a 50% reduction in a person's score on either scale. It is worth noting that a large number of participants did not finish the trial — 11 of 15 in the quetiapine SR group and 9 of 13 in the placebo group did not complete it. The reported data shows that, for both the depression measure (MADRS) and the mania measure (YMRS), 4 out of the 15 participants in the quetiapine SR group met the threshold for mood improvement (a 50% reduction in their score). In the placebo group, the reported data also shows 4 out of 13 participants met that same threshold on both scales. No other outcome measures were reported in the submitted results. It is important to note that this was a very small trial with a high number of people who did not finish, which means the numbers above reflect only a limited picture of what was studied. 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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NCT01121536 · results posted 26 January 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 867 people who were given armodafinil at a dose of 150–200 mg per day. There was only one group in this study — no comparison or placebo group. Of those who started, 506 completed the trial and 361 did not finish. The trial was measuring a range of safety-related things, including any unwanted health events that came up during treatment (called "treatment-emergent adverse events"), as well as changes in blood tests, urine tests, vital signs (like blood pressure and heart rate), and heart tracing (ECG) readings. The reported data shows that out of 863 people included in the safety analysis, 423 experienced at least one treatment-emergent adverse event during the study. Of those, 26 were reported as serious (meaning they involved hospitalisation, a life-threatening situation, or another significant medical outcome). The data also shows that 57 participants had events the investigators considered related to the study medication, and 19 had severe adverse events. No deaths were reported. For blood chemistry tests, the reported data shows that 41 participants had at least one result flagged as a clinically significant abnormal value. For blood count (haematology) tests, 13 participants had at least one flagged result. For urine tests, 28 participants had at least one flagged result. For vital signs, 19 participants had at least one reading outside the clinically significant threshold. For ECG (heart tracing) readings, the reported changes from the start of the study to the end were small — all under 2.5 milliseconds in either direction across the different measurements tracked. 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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NCT01072630 · results posted 26 January 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 492 adults across three groups: 230 received a placebo (a dummy treatment with no active ingredient), 232 received armodafinil at 150 mg per day, and 30 received armodafinil at 200 mg per day. The trial was measuring changes in the severity of depressive symptoms over 8 weeks, using a clinician-rated questionnaire called the IDS-C30, which scores depression from 0 (no depression) to 84 (most severe). A lower score — or a drop from the starting score — indicates fewer reported depressive symptoms. Around 364 participants completed the full study period. The reported data shows that, on the primary measure, all three groups saw their IDS-C30 scores fall over the 8 weeks. The placebo group's average score dropped by 18.8 points, the 150 mg armodafinil group's dropped by 20.9 points, and when both armodafinil doses were combined the drop was 20.7 points. For the secondary measures, the reported data shows that by week 8, about 36% of the placebo group, 41% of the 150 mg group, and 56% of the 200 mg group were classed as "responders" — meaning their score had fallen by at least half from where it started. Regarding remission (defined as reaching a score of 11 or below), the reported figures at week 8 were approximately 19% for placebo, 15% for the 150 mg group, and 39% for the 200 mg group. Similar patterns across the weeks were also reported for two other depression-rating scales (the QIDS-C16 and CGI-S), with all groups showing reductions from their starting points across the 8-week period. It is worth noting that the 200 mg armodafinil group was considerably smaller (around 30 people) than the other two groups, which the reported data does not explain further. No safety or side-effect data has been described here, as it was 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00499096 · results posted 20 November 2014
According to the results reported on ClinicalTrials.gov, this trial involved 118 people with bipolar disorder — 58 in one group and 60 in another. One group received a "Chronic Care Model" approach specifically designed for bipolar disorder, while the other received what was called "enhanced usual care." The trial ran for 24 months and was measuring physical health markers (blood pressure and cholesterol), physical quality of life, as well as mood-related symptoms and disability. By the end of the study, 35 people in the first group and 40 in the second had completed it, with 23 and 20 people respectively not finishing. The reported data shows the following results at the end of the study. For blood pressure (measured in millimetres of mercury, where lower numbers are considered better), the Chronic Care Model group had a reading of 127.2/75.9, compared with 130.4/78.5 in the enhanced usual care group. For total cholesterol (where lower is considered better), the figures were 178.9 mg/dL versus 175.9 mg/dL. For physical quality of life — scored on a scale of 0 to 50, where higher means better — the scores were 36.8 versus 35.3. On a scale measuring manic symptoms (0 to 500, higher meaning more severe), scores were 148.9 versus 173.4. Depressive symptoms (0 to 200, higher meaning more severe) scored 50.6 versus 60.3. Finally, for disability (0 to 24, higher meaning greater disability), scores were 15.0 versus 16.5. The reported data shows differences between the two groups across all of these measures, but this summary simply describes the numbers as submitted — it does not indicate whether those differences are meaningful or due to chance, and no claims are made here about whether either approach is better or worse. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01076361 · results posted 27 October 2014
According to the results reported on ClinicalTrials.gov, this trial involved 370 people who received a specific cardiac lead device called the Model 4968 Lead — a type of wire used with heart devices to deliver electrical signals. Of those who started the trial, 349 completed it, while 21 did not finish. The trial was set up to track how often participants experienced complications that were directly related to this lead device over time. The reported data shows that the main thing being measured was "lead survival probability" — that is, the likelihood that the lead device would remain free from lead-related complications over the follow-up period. Using a statistical method called the life-table method (which accounts for how long each participant was followed and whether they experienced a complication), the reported survival probability was 92.3%. In plain terms, this means that based on the reported figures, roughly 92 out of every 100 leads were recorded as not having experienced a lead-related complication by the end of the follow-up period. No secondary outcome measure data was reported in the submitted results. It is worth noting that the data submitted covers only this one reported figure, and no additional outcome numbers were included in the results as 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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NCT00835120 · results posted 17 October 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 34 people, all of whom received pioglitazone (a medication sometimes used for type 2 diabetes). The trial was measuring changes in depression symptoms over the course of the study, using several standardised questionnaires and clinician rating tools. Of the 34 people who started, 26 completed the trial and 8 did not finish. The reported data shows that, on the main depression rating scale used by clinicians (the IDS-CR, which runs from 0 to 84, where higher numbers mean more severe symptoms), participants' scores dropped by an average of 16.5 points from the start of the study to the end. On a separate self-reported depression questionnaire (the QIDS-SR, scored 0 to 27), scores fell by an average of 7.1 points. A clinician's overall rating of how unwell participants appeared (the CGI-BP, on a 1–7 scale) also dropped by an average of 1.9 points. The reported data also shows that 13 out of the participants were classed as "responders" — meaning their depression scores on certain scales dropped by at least 50% over the eight weeks — and 8 participants were classed as being in "remission," meaning their scores on the rating scales fell below set thresholds at the eight-week mark. No comparison group (such as a placebo group) was included in the data reported, so these numbers reflect changes within the 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00125931 · results posted 4 September 2014
According to the results reported on ClinicalTrials.gov, this trial involved 10 participants, all of whom were in a single treatment group. All 10 people who started the trial completed it. The trial was measuring symptoms of mania — a state of unusually high mood, energy, or agitation — using two different rating scales at various points during the study. The reported data shows that mania symptoms were tracked using a scale called the MACS (Mania Acute Change Scale), which runs from 0 to 80, where a higher number means more severe or numerous symptoms. At one point in time, the reported average score across participants was 18.6, and at a later point it was 11.0. A second scale, called the YMRS (Young Mania Rating Scale), runs from 0 to 44 using the same principle. The reported average YMRS scores across three points in time were 23.6, then 22.0, and then 12.7. The data does not specify the exact timing of each measurement, and no comparison group or control group data was reported. It is worth noting that this was a very small study with only 10 participants and no comparison (placebo) group, which means the reported numbers on their own have important limitations in what they can tell us. The reported data shows changes in scores over time, but what those changes mean in a broader sense was not explained 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01460290 · results posted 5 August 2014
According to the results reported on ClinicalTrials.gov, this trial looked at a medication called asenapine in 15 people. There was only one group — everyone received asenapine, with no comparison group. The trial was measuring changes in depressive symptoms, manic symptoms, and overall mental health and wellbeing over the course of the study. Of the 15 people who started, 11 completed the trial and 4 did not finish. The reported data shows the following numbers before and after the study period. For depressive symptoms (measured on the Hamilton Depression Rating Scale, where higher numbers mean worse symptoms out of a maximum of 52), scores went from 17.5 at the start to 10.3 at the end. For manic symptoms (measured on the Young Mania Rating Scale, out of a maximum of 60), scores went from 27.9 to 18.1. A separate depression scale (the MADRS, out of 60) also recorded scores of 27.9 at the start and 18.1 at the end. For overall illness severity (rated on a 1–7 scale, where higher is worse), the reported data shows scores for mania severity moved from 4.4 to 2.2, depression severity from 2.7 to 1.9, and overall bipolar illness severity from 3.6 to 1.7. For self-rated physical health (on a scale where higher means better perceived health, out of 99), scores were 46.8 at the start and 46.4 at the end. For self-rated mental health on the same type of scale, scores were 38.7 at the start and 43.1 at the end. It is worth noting that this was a very small trial with only 15 participants and no comparison group, which limits what can be drawn from these numbers alone. The reported data does not include information about side effects or safety outcomes. 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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NCT00787930 · results posted 31 July 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 19 participants, all placed in a single "naturalistic treatment" group. The study was looking at whether certain features visible on brain MRI scans — specifically small bright spots in the white matter of the brain (called "deep white matter hyperintensities") — were linked to how people with mania responded to treatment and whether their mood disorder returned over time. All 19 participants completed the initial three-week treatment phase, while 3 of the 19 did not complete the longer follow-up period of up to 12 months. The reported data shows that during the acute (short-term) treatment phase, 10 participants were classified as responders to treatment and 9 were classified as non-responders, based on their clinical outcomes. Both groups were assessed for the presence of larger brain white matter bright spots (rated above 2 on a five-point scale where 0 means none and 4 means extensive). For the longer follow-up phase, 4 participants experienced a return of depression or mania (relapse) and 4 did not — noting that the total here is 8, not 16, and the data as reported does not account for all who completed this phase. Among those assessed for a different type of brain scan feature (subcortical bright spots), 2 participants in the relapse group and 4 in the non-relapse group had higher scores. The reported data also shows brain scan measurements of a property related to how water moves through brain tissue (a technical measure called "fractional anisotropy," scored 0–100) in two frontal brain regions: in the left frontal area, the relapse group scored 76.3 and the non-relapse group scored 81.4; in the right frontal area, scores were 76.1 and 79.8 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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NCT01293825 · results posted 22 April 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people with bipolar disorder, all placed in a single group focused on medication adherence. Of those 30, 20 completed the study and 10 did not finish. The trial was looking at how consistently participants took their prescribed medication, as well as a number of related measures including their attitudes toward medication, their overall mental health symptoms, and how well they were managing day-to-day life and work. The reported data shows that the main measure — how often participants missed their medication doses, as recorded by a questionnaire called the Tablet Routines Questionnaire (TRQ) — produced two figures: 16.11% and 13.88% (on a scale of 0–100%, where a higher number means more doses missed). The trial record does not clarify what time points these two figures represent. For the secondary measures, the reported data shows a score of 2.90 out of 4 on the Morisky Rating Scale (which tracks medication-taking habits, where lower means fewer problems), 6.10 out of 10 on the Drug Attitude Inventory (where higher reflects a more positive attitude toward medication), 2.25 out of 7 on the Clinical Global Impressions scale (a clinician's rating of illness severity, where lower means less severe), 54.40 out of 100 on the Social and Occupational Functioning Scale (where higher means better day-to-day functioning), and 12.35 out of 60 on the Montgomery Åsberg Depression Rating Scale (which measures depressive symptoms, where lower means fewer symptoms 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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NCT00606177 · results posted 12 February 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 55 people who received aripiprazole and 44 people who received a placebo (an inactive dummy treatment). Of those, 28 in the aripiprazole group and 19 in the placebo group completed the study, meaning a notable number of participants did not finish in both groups. The trial was measuring changes in symptoms of mania in people with bipolar disorder over approximately 22 weeks (154 days), using two rating scales completed by clinicians. The reported data shows that the primary measure was the Young Mania Rating Scale (YMRS), which runs from 0 (no symptoms) to 60 (most severe). A lower score — or a bigger drop from the starting score — means fewer reported symptoms. From the beginning of the study to the end, the aripiprazole group's score dropped on average by 22.6 points, while the placebo group's score dropped on average by 15.4 points. For the secondary measure — a clinician's overall rating of mania severity on a scale of 1 (not ill) to 7 (very severely ill) — the aripiprazole group's score dropped on average by 2.9 points, compared to a drop of 1.9 points in the placebo group. These numbers reflect averages across the group and do not represent any individual's experience. It is also worth noting that the data used a statistical method called "last observation carried forward" (LOCF), which means that for participants who dropped out early, their last recorded score was used as their final result rather than a new measurement being taken. 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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NCT00720369 · results posted 13 January 2014
According to the results reported on ClinicalTrials.gov, this trial involved 19 people in total: 11 people with bipolar depression who took a CoQ10 supplement (a naturally occurring compound sometimes taken to support energy production in cells), and 8 healthy volunteers included for comparison. Of those who started, 10 people in the CoQ10 group and all 8 healthy volunteers completed the study. The trial was measuring two things: a specific chemical process in the brain and muscles related to energy production (involving an enzyme called creatine kinase), and the severity of depression symptoms in the bipolar group after 8 weeks of taking CoQ10. The reported data shows that, for the main measurement — the speed of a chemical reaction in the body that helps convert stored energy into usable energy — the CoQ10 group had a rate of 0.02 per second, while the healthy volunteers had a rate of 0.03 per second. These figures represent how quickly this energy-conversion process was occurring. For the secondary measurement, depression symptom severity was rated using a 60-point questionnaire (where higher scores mean more severe symptoms). The reported data shows the CoQ10 group scored an average of 21.4 points before treatment and 18.4 points after the 8-week period. No comparison depression scores were reported for the healthy volunteer group, as this measure was only assessed in the bipolar group. It is worth noting that this was a small study involving fewer than 20 people, and the data as submitted provides only these summary numbers without further context about how meaningful the differences observed may or may not be. 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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NCT00490542 · results posted 8 January 2014
According to the results reported on ClinicalTrials.gov, this trial involved 73 people in total — 38 in a placebo group (a dummy treatment with no active ingredient) and 35 in a ziprasidone group (an active medication). The trial was measuring changes in depression symptom severity over time, using a standardised questionnaire called the Montgomery-Åsberg Depression Rating Scale, or MADRS. This scale runs from 0 to 40, where 0 means no depressive symptoms at all and 40 means the most severe symptoms — so a lower score, or a larger drop in score, indicates fewer reported symptoms. By the end of the trial, 31 people in each group had completed it. The reported data shows that the primary outcome — the change in MADRS scores over the course of the study — differed between the two groups. The ziprasidone group showed an average change of 11.4 points on the MADRS scale, while the placebo group showed an average change of 5.9 points. The trial report does not provide full detail on the direction of these changes (for example, whether scores went up or down from a starting point), and no further breakdown of results was included in the data submitted to ClinicalTrials.gov. It is worth noting that no secondary outcome measure data was included in the structured results 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00667745 · results posted 28 June 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 283 adults with bipolar disorder — 141 in a group receiving a treatment approach called Optimised Pharmacological Treatment (OPT) that included lithium, and 142 in a group receiving OPT without lithium. Of those, 116 and 121 participants respectively completed the study. The trial was primarily measuring two things: how much participants' overall bipolar illness severity changed over the course of the study, and how many times doctors needed to adjust their medications along the way. The reported data shows that, on a severity scale running from 1 (normal) to 7 (most extremely ill), the average score change across the study period was −1.22 for the group taking lithium and −1.48 for the group not taking lithium — meaning both groups' average scores moved in the direction of lower severity. For medication adjustments, the lithium group averaged 1.17 changes and the non-lithium group averaged 1.26 changes over the 24-week study. On the secondary measures, the reported data shows average depression symptom scores (out of a possible 60) of 8.20 (lithium group) and 8.84 (non-lithium group); average mania symptom scores (out of 60) of 6.35 and 5.79 respectively; and average suicidal ideation scores (out of 54) of 0.73 and 1.10 respectively. These figures represent scores recorded during the study period, not changes from a starting point, and no starting-point (baseline) scores were 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01825837 · results posted 17 June 2013
According to the results reported on ClinicalTrials.gov, this trial (NCT01825837) involved a medicine called ESL (also referred to as BIA 2-093) and was carried out in two parts. In Part I, 104 participants were enrolled in an open-label phase (meaning everyone received the same treatment and knew what they were taking), and 87 of them completed it. In Part II, 87 of those participants were then randomly assigned to one of three different daily doses — 300 mg (35 people), 900 mg (26 people), or 1800 mg (26 people) — in a double-blind phase (meaning neither the participants nor the researchers knew who was receiving which dose). The trial was looking at a condition related to bipolar disorder and was measuring whether participants' symptoms stayed stable or got worse over time. The main thing the trial measured was the proportion of people who showed no worsening of their condition, as judged by a standard clinical rating scale called the CGI-BP (a tool where a clinician scores how ill someone appears, from "not ill" to "very severely ill"). A participant was considered to have worsened if their score on any part of the scale — covering mania, depression, or overall illness — reached a certain threshold at any point during Part II. The reported data shows that, out of those included in the main analysis, 26 out of 34 participants in the 300 mg group, 14 out of 25 in the 900 mg group, and 16 out of 26 in the 1800 mg group showed no worsening according to this scale. No secondary outcome measure data was included in the submitted results. It is worth noting that a relatively high number of participants did not complete Part II — 19 in the 300 mg group, 14 in the 900 mg group, and 19 in the 1800 mg group — 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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NCT00868452 · results posted 2 April 2013
According to the results reported on ClinicalTrials.gov, this trial looked at lurasidone compared to a placebo (a dummy treatment with no active ingredient) in people with bipolar depression. A total of 183 people were assigned to take lurasidone and 165 were assigned to take the placebo. Of those, 143 in the lurasidone group and 136 in the placebo group completed the study. The trial ran for 6 weeks and used several rating scales to measure changes in depression symptoms and day-to-day functioning. The reported data shows the following for the main measure — a depression rating scale called the MADRS, which runs from 0 (no symptoms) to 60 (most severe). A bigger drop in score means greater improvement. The lurasidone group showed an average drop of 17.1 points from their starting score, while the placebo group showed an average drop of 13.5 points. For a secondary measure of overall illness severity (rated 0–7, lower being better), the lurasidone group dropped by an average of 1.96 points compared to 1.51 points in the placebo group. For a third measure looking at how much symptoms interfered with daily life — work, social activities, and home life (rated 0–30, lower being better) — the lurasidone group dropped by an average of 9.5 points, while the placebo group dropped by 7.0 points. In every measure, both groups showed a decrease from their starting scores by the end of the 6 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00057681 · results posted 27 March 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 379 children and adolescents with bipolar disorder who were experiencing manic or mixed symptoms. They were randomly assigned to one of three medications — lithium (137 participants), divalproex sodium (139 participants), or risperidone (103 participants) — and followed for 8 weeks. The trial was measuring changes in mania symptoms using rating scales completed by clinicians, as well as tracking side effects reported by participants. The reported data shows that for the main measure — a clinician's rating of mania improvement on a 1–7 scale (where 1 means "very much improved" and 7 means "very much worse") — the average scores at the end of the study were 2.49 for the lithium group, 2.73 for the divalproex sodium group, and 1.70 for the risperidone group. A separate mania rating scale (scored 0–64, where higher scores indicate more severe mania) showed average end-of-study scores of 24.06 for lithium, 26.31 for divalproex sodium, and 14.58 for risperidone. For the side effects measure — which counted side effects rated as moderate or severe — the average number of such side effects reported at week 8 was 5.11 for lithium, 4.95 for divalproex sodium, and 3.70 for risperidone. It is worth noting that a substantial number of participants did not complete the study across all 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00844857 · results posted 18 February 2013
According to the results reported on ClinicalTrials.gov, this trial looked at a combination medication (olanzapine and fluoxetine together) compared to a placebo (a dummy treatment with no active ingredient) in children and adolescents with bipolar depression. A total of 194 young people were assigned to the combination medication group and 97 to the placebo group, though not all participants completed the 8-week study. The main thing the trial was measuring was how much participants' scores changed on a depression rating scale called the CDRS-R, where higher scores indicate more severe depression. The reported data shows that, on average, participants in the combination medication group had their CDRS-R depression score drop by about 28.4 points over 8 weeks, while those in the placebo group had an average drop of about 23.4 points. For the secondary measures, 59% of participants in the combination group met the criteria for "remission" (meaning their scores fell below certain thresholds across several rating scales), compared with 43.4% in the placebo group. Around 78.2% of the combination group showed a "response" (at least a 50% reduction in their depression score), compared with 59.2% in the placebo group. The reported data also shows small reductions in scores on a scale measuring manic symptoms and a general severity scale, with the combination group showing slightly larger reductions in both 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00665366 · results posted 4 February 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 370 people with bipolar disorder who were already taking a mood stabiliser (either valproate or lithium). Of these, 189 were assigned to also take a placebo alongside their mood stabiliser, and 181 were assigned to also take aripiprazole alongside their mood stabiliser. The trial ran for 12 weeks and was mainly measuring changes in manic symptoms using a clinician-rated questionnaire called the Young Mania Rating Scale (YMRS), where scores run from 0 to 60 and higher scores indicate more severe mania. The reported data shows that, on the main measure, both groups had lower YMRS scores at the end of the trial compared to where they started. The placebo-plus-mood-stabiliser group's score dropped by an average of about 11.5 points, while the aripiprazole-plus-mood-stabiliser group's score dropped by an average of about 13.6 points. On a secondary measure that asked clinicians to rate the overall severity of mania on a 1–7 scale (where lower is better), the reported data shows both groups also recorded lower scores over time, with small differences between the two groups at various check-in points. Regarding the proportion of participants whose YMRS score improved by 50% or more from the start — what the trial called a "response" — the reported data shows that by week 12, approximately 61% of the placebo group and approximately 69% of the aripiprazole group met this threshold. The reported data also includes secondary measures looking at depression severity and day-to-day functioning, and the numbers in both groups changed only modestly across those measures over the 12 weeks. It is worth noting that not everyone completed the trial: 58 people in the placebo group and 59 in the aripiprazole group did not finish, and reasons for not completing 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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NCT00538642 · results posted 19 November 2012
According to the results reported on ClinicalTrials.gov, this trial involved 24 people in total — 10 who stayed on their current antipsychotic medication and 14 who switched to a medication called ziprasidone. The trial was looking at how the body processes insulin (a hormone that controls blood sugar), as well as body measurements like weight, waist size, and blood pressure. By the end of the study, 9 people in each group had completed it, meaning 1 person dropped out from the "stay on current medication" group and 5 from the ziprasidone group. The reported data shows that the primary thing being measured was insulin sensitivity — essentially, how well the body responds to insulin. This was measured using a specialised method called a euglycemic clamp. The group that stayed on their current antipsychotic returned a figure of 5.55 (in the technical units used), while the ziprasidone group returned a figure of 1.88. For the secondary measurements, the reported data shows body mass index (a measure of body weight relative to height) was around 38–39 kg/m² for both groups at one time point, and around 36 and 38.8 kg/m² respectively at another time point. Waist (abdominal) circumference was reported as 115 cm for the group staying on their current medication and 126 cm (then 122 cm at a later point) for the ziprasidone group. Systolic blood pressure (the top number in a blood pressure reading, reflecting pressure when the heart beats) was 118 mmHg for the current antipsychotic group and 121 mmHg for the ziprasidone group. It is worth noting that the trial was quite small in size, and the reported data does not include information about whether the differences between groups were considered statistically meaningful (i.e., unlikely to be due to chance). 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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NCT00109577 · results posted 11 September 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 40 adults in total — 20 in a placebo group and 20 in a group receiving a micronutrient formula. Of those, 17 in each group completed the study, with 3 in each group not finishing. The trial was measuring changes in mood in people with bipolar disorder, using a scoring tool called the Bipolarity Index, which combines two separate mood rating scales — one for depression and one for mania. On this combined scale, scores range from 0 to 103, where higher numbers indicate worse symptoms. The reported data shows that both groups had lower scores by the end of the trial compared to where they started, meaning both groups showed a reduction in their symptom scores over time. The placebo group's score dropped by an average of 21.1 points, while the micronutrient formula group's score dropped by an average of 18.9 points. These are the raw numbers as submitted — the trial does not report whether the difference between the two groups was considered meaningful in statistical terms. For the four secondary outcome measures — including the Global Clinical Impressions scale, a self-report questionnaire, and the SF-36 health survey — no numerical results were included in the data submitted to ClinicalTrials.gov, so those figures 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00102518 · results posted 31 August 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 325 participants, all of whom had previously taken part in two related studies (identified as NCT00102063 and NCT00110461). Of those 325 people, 238 completed the trial, while 87 did not finish. The trial was measuring the rate of serious adverse events (that is, serious unwanted health occurrences) as its main focus, and also tracked changes in two symptom rating scales — one measuring symptoms associated with schizophrenia (the PANSS scale) and one measuring symptoms associated with mania (the Y-MRS scale). The reported data shows that 6.2% of participants experienced a serious adverse event during the study. For the schizophrenia symptom scale (PANSS), scores can range from 30 (fewest symptoms) to 210 (most symptoms); the reported data shows an average change of minus 7.5 points from the start of the study to the last recorded measurement, meaning scores moved slightly toward the lower (fewer symptoms) end of the scale. For the mania symptom scale (Y-MRS), scores range from 0 (no symptoms) to 60 (most severe); the reported data shows an average change of minus 7.74 points from the start of the study to the last recorded measurement, again moving toward the lower end of the scale. It is important to note that this trial had no separate comparison group, so all figures reflect the single group of participants described above. 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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NCT01113541 · results posted 9 July 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 13 participants, all of whom received the medication ziprasidone. The trial was set up to measure changes in risk factors for a condition called metabolic syndrome — a cluster of physical measurements including waist size, blood fat levels (triglycerides), "good" cholesterol (HDL) levels, blood sugar, and blood pressure. The study was planned to run for 52 weeks, but the reported data shows that none of the 13 participants completed the full study — all 13 left early. The reported data shows that for the primary outcome — the percentage of participants who had at least one fewer metabolic syndrome risk factor at their final measurement compared to when they started — the figure was 50%. Because all participants left the study before the 52-week mark, this measurement was taken at the point each person exited the trial rather than at the planned end point. For the secondary outcome measures, which looked at things like the overall number of risk factors, the prevalence of metabolic syndrome, and changes in individual risk factors such as waist circumference, the reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of these measures. Given that all participants left before completing the trial and that most secondary outcome data was not reported, the picture the data provides is very limited. 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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NCT00592358 · results posted 4 July 2012
According to the results reported on ClinicalTrials.gov, this trial involved 17 people who were given a medication called paliperidone. The trial was measuring changes in manic symptoms in people with bipolar disorder, using two different rating scales completed by clinicians over the course of the study. Of the 17 people who started the trial, 11 completed it and 6 did not. The reported data shows that on the first scale — the Young Mania Rating Scale (YMRS), which runs from 0 (no symptoms) to 60 (most severe symptoms) — participants had an average score of 32.8 at the start of the study and 14.1 at a later measurement point. On the second scale — a 13-item mania symptom checklist developed by Massachusetts General Hospital, which runs from 0 (least severe) to 39 (most severe) — participants had an average score of 18.5 at the start and 10.9 at a later measurement point. The reported data does not include details about exactly when the follow-up measurements were taken or how individual participants varied in their scores. It is worth noting that this was a small, single-group study with no comparison group, and that 6 out of 17 participants did not complete the trial — information about why they left was not reported 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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NCT00490971 · results posted 5 March 2012
According to the results reported on ClinicalTrials.gov, this trial looked at adults with Bipolar I Disorder who had experienced a manic or mixed episode. The trial had two phases. In the first (acute/continuation) phase, 614 people received paliperidone ER and 148 received olanzapine, both well-known medicines used in bipolar disorder. After about 15 weeks, those who had remained stable were moved into a second (maintenance) phase, where they were placed into one of three groups: 147 people continued on paliperidone ER then switched to a placebo (inactive treatment), 149 people stayed on paliperidone ER throughout, and 83 people stayed on olanzapine. The main thing being measured was how long it took before mood symptoms — either manic or depressive — came back during the maintenance phase. The reported data shows that, for the primary outcome (time until any mood symptoms returned), the group that switched from paliperidone ER to placebo reached that point in a reported median of 85 days, compared to 140 days for those who stayed on paliperidone ER, and 541 days for those who stayed on olanzapine. (A "median" here simply means the midpoint — half the group reached that point before this time, and half after.) For the secondary outcome focusing specifically on manic symptoms returning, the placebo-switch group reached that point at a reported median of 194 days, while the group that continued paliperidone ER reached 498 days; a median was not reported for the olanzapine group in that comparison. For depressive symptom recurrence, the figures reported were 503 days for the placebo-switch group and 448 days for the paliperidone ER continuation group; a figure for the olanzapine group was not reported. The reported data also includes scores from several rating scales used to track mood and daily functioning. On the mania scale (scored 0–60, where higher is more severe), both the paliperidone ER and olanzapine groups showed decreases of around 19 points during the first phase, while during the maintenance phase scores increased (worsened) by 9.0, 4.2, and 1.3 points in the placebo-switch, paliperidone ER continuation, and olanzapine continuation groups respectively. Similar patterns were reported for the depression rating scale and the general functioning scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00763919 · results posted 21 December 2011
According to the results reported on ClinicalTrials.gov, this trial (NCT00763919) tested a programme called Customised Adherence Enhancement (CAE), which was designed to support people in taking their prescribed medications as directed. The trial enrolled 43 participants, of whom 30 completed the study and 13 did not finish. There was only one group — everyone received the CAE programme — so the trial tracked how scores changed over time within that single group, rather than comparing it against a separate control group. The reported data shows changes in scores on several questionnaires used to measure how consistently participants took their medication, as well as their attitudes toward mood-stabilising medicines. On the Tablet Routines Questionnaire (a scale from 0 to 100, where higher numbers mean poorer adherence), the reported average score change was between −20.6 and −28.9 points across different time points measured — meaning scores moved in the direction of better adherence. On the Morisky Scale (0 to 4, higher meaning poorer adherence), the reported average change was −1.7 points. For the two attitude questionnaires, the Attitude Toward Mood Stabilizers Questionnaire (0–19 scale) showed an average change of −4.1 points, and the Rating of Medication Influences scale (0–10) showed an average change of −1.8 points — both moving in the direction of more positive attitudes. No comparison group data was reported. It is important to note that because there was no comparison group, the reported numbers reflect changes from the start to the end of the programme within 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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NCT00830310 · results posted 24 November 2011
According to the results reported on ClinicalTrials.gov, this trial involved 43 people diagnosed with bipolar disorder who received a programme called Customised Adherence Enhancement (CAE). This was a single-group study — meaning there was no comparison group — designed to look at whether the programme was associated with changes in how consistently participants took their medications, as well as changes in mood symptoms, overall functioning, and attitudes toward treatment. Of the 43 people who started, 30 completed the study, and 13 did not complete it. The reported data shows that the main thing being measured was medication non-adherence — essentially, what percentage of their prescribed medications participants reported not taking in the past month (where a higher percentage means worse adherence). The reported average change in this score was a decrease of 23.6 percentage points, meaning participants reported missing a smaller proportion of their medications compared to when they started. For the secondary measures, the reported data shows average changes from the start of the study to the end across several rating scales: manic symptoms (measured on a 0–60 scale) decreased by an average of 3.7 points; overall illness severity (measured on a 1–7 scale) decreased by an average of 0.67 points; attitudes toward medication (measured on a 0–10 scale, where higher is more positive) increased by an average of 1.7 points; overall day-to-day functioning (measured on a 1–100 scale, where higher is better) increased by an average of 8.2 points; and depressive symptoms (measured on a 0–52 scale) decreased by an average of 2.4 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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NCT00566020 · results posted 27 July 2011
According to the results reported on ClinicalTrials.gov, this trial involved 92 participants who were given the medication lamotrigine. The study ran in two back-to-back stages: a 6-week dose adjustment phase, followed by a 46-week long-term phase. Of the 92 who started, 85 completed the first stage and moved into the second stage, and 68 of those finished the full trial. The trial was primarily measuring participants' blood test results and any medical events (called adverse events) that occurred while taking the medication — it was not designed to test whether the medication reduced symptoms. The reported data shows that, when it came to medical events, 13 out of 92 participants experienced a serious adverse event (meaning something that was life-threatening, required hospitalisation, or caused significant disability), while 75 participants experienced at least one non-serious adverse event of some kind. For the blood tests, the reported data shows that at various points throughout the trial, the large majority of participants had results within the normal range for each measure tested — including liver-related markers, kidney markers, electrolytes (salts in the blood), blood counts, and proteins. Smaller numbers of participants had individual results that fell outside the normal range at one or more time points, though the data does not indicate whether those changes were linked to the medication. A full list of adverse events was noted as being available separately in the trial record. 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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NCT00391222 · results posted 1 November 2010
According to the results reported on ClinicalTrials.gov, this trial involved people with bipolar disorder and was run in stages. In the first open-label stage, 560 participants received injections of a long-acting form of risperidone (a medication given by injection every few weeks), and 398 of them completed that stage. Those who remained stable then moved into the main double-blind stage — meaning neither the participants nor their doctors knew who was receiving which treatment — where 132 people were assigned to continue with risperidone injections, 135 received a placebo (an inactive injection), and 131 received olanzapine (another medication in tablet form). The trial was primarily measuring how long it took before participants experienced a return of a mood episode, such as a manic or depressive episode. The reported data shows that for the main comparison — risperidone injections versus placebo — the estimated average time before a mood episode returned was approximately 293 days for the risperidone group and approximately 270 days for the placebo group. For episodes involving elevated mood (such as mania), the reported figures were around 357 days for risperidone, 323 days for placebo, and 448 days for olanzapine. For depressive episodes, the reported figures were approximately 214 days for risperidone, 300 days for placebo, and 356 days for olanzapine. The trial also measured changes in standard mood rating scale scores; on the mania scale, scores changed by an average of 2.9 points (risperidone), 8.0 points (placebo), and 1.7 points (olanzapine), while on the depression scale, changes were 5.1 points, 6.1 points, and 2.0 points respectively — with higher scores on both scales indicating more severe symptoms. 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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NCT00277212 · results posted 20 October 2010
According to the results reported on ClinicalTrials.gov, this trial involved two phases. In the first, open-label phase, 787 people took part, all receiving a combination of two medicines — lamotrigine and aripiprazole. Of those, 352 completed this phase. Those who responded well enough were then moved into a second, double-blind phase (meaning neither the participant nor their doctor knew which treatment they were receiving), where 351 people were randomly assigned to continue on either lamotrigine plus aripiprazole (178 people) or lamotrigine plus a placebo — a dummy pill with no active ingredient (173 people). The trial was primarily measuring how many people in each group did not experience a relapse into a manic or mixed mood episode over 52 weeks. The reported data shows that, by the end of the 52-week double-blind phase, the estimated proportion of participants who had not experienced a manic or mixed episode relapse was 0.89 (roughly 89 in every 100) in the lamotrigine-plus-placebo group, and 0.90 (roughly 90 in every 100) in the lamotrigine-plus-aripiprazole group. For relapses of any type — including depressive episodes — the reported figures at 52 weeks were approximately 0.76 (76 in every 100) for the placebo group and 0.82 (82 in every 100) for the aripiprazole group. For depressive relapses specifically, the figures were approximately 0.85 and 0.90 respectively. The reported data also shows that, on average, body weight changed by −1.81 kg in the placebo group and +0.43 kg in the aripiprazole group over the double-blind phase. Regarding other reported measures, the data shows that no deaths occurred in either group during the double-blind phase. Serious unwanted medical events were reported in 9 participants in the placebo group and 5 in the aripiprazole group. Side effects related to involuntary muscle movements (a category called extrapyramidal events) were reported in 15 participants in the placebo group and 28 in the aripiprazole group. The proportion of participants who remained in the study without stopping for any reason was reported as approximately 0.61 (placebo group) and 0.65 (aripiprazole group) at 52 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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NCT00550407 · results posted 27 July 2010
According to the results reported on ClinicalTrials.gov, this trial involved people with a mood disorder (likely bipolar disorder, based on the measures used) and was conducted in two stages. In the first stage — an open-label preliminary phase lasting 8 to 16 weeks, where everyone knew what they were receiving — 215 participants started taking lamotrigine at doses between 25 and 200 mg, and 103 of them completed that phase. Those who completed it were then entered into a second, 26-week randomised phase, where 58 participants were assigned to a placebo (a dummy treatment) and 45 were assigned to a fixed dose of lamotrigine 200 mg. In this second phase, 15 of the placebo group and 21 of the lamotrigine group finished the full 26 weeks. The reported data shows that the main thing being measured in the randomised phase was how long participants stayed in the study before withdrawing for any reason. According to the results reported on ClinicalTrials.gov, the median time (the midpoint — half of participants lasted longer, half shorter) before withdrawal was 67.5 days for the placebo group. A corresponding figure for the lamotrigine group was not reported, as the trial notes it could not be calculated. For one of the secondary measures — how long until a doctor decided a participant needed extra treatment for any mood episode — the reported median time was 109 days for the placebo group, with no figure reported for the lamotrigine group. Two other secondary time-based measures (time to needing treatment specifically for a depressive episode, or for a manic/mixed episode) had no data reported for either group. On a global improvement rating scale running from 1 (very much improved) to 7 (very much worse), participants in the randomised phase scored an average of 3.5 in the placebo group and 2.4 in the lamotrigine group at week 26 or when they left the study; during the preliminary open-label phase, participants scored an average of 3.1 on the same scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00552760 · results posted 5 July 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 83 people in total — 42 received a medication called ramelteon (a sleep-regulating medicine) and 41 received a placebo (a dummy pill with no active ingredient). The trial was designed to measure sleep quality and mood-related symptoms in people with bipolar disorder over time. Notably, a large number of participants did not complete the study — 26 in the ramelteon group and 33 in the placebo group left before the end. The reported data shows that the main thing being measured was sleep quality, using a questionnaire called the Pittsburgh Sleep Quality Index, where higher scores mean worse sleep (the scale runs from 0 to 21). At the start, both groups had similar scores (ramelteon: 10.17, placebo: 10.88). By the final assessment, the ramelteon group's average score had dropped to 6.62, while the placebo group's was 8.66. For the secondary measures — which looked at depression symptoms, manic symptoms, and overall illness severity — the reported data shows the ramelteon group's scores were generally lower (meaning less severe) than the placebo group's at later time points, though both groups started at similar levels. For example, on the depression scale (0–60), scores at the last time point were 8.56 for ramelteon and 11.59 for placebo. A separate analysis tracking how long participants went without a relapse found that by the final check-in, around 63% of the ramelteon group and 32% of the placebo group had not experienced a relapse, based on the figures 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00483548 · results posted 23 February 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 298 people in total — 148 in the ziprasidone group and 150 in the placebo (dummy treatment) group. The trial ran for 6 weeks and was measuring changes in depressive symptoms in people with bipolar disorder. The main thing being measured was a standard clinician-rated questionnaire called the MADRS (Montgomery-Åsberg Depression Rating Scale), which scores depression symptoms from 0 to 44, where a higher number means more severe symptoms. By the end of the study, 88 people in the ziprasidone group and 104 in the placebo group completed the full 6 weeks. The reported data shows that, on the main outcome measure, the ziprasidone group's average MADRS score fell by 14.7 points from their starting score over 6 weeks, while the placebo group's average score fell by 13.2 points. For a separate overall illness severity rating (the CGI-S, scored 1–7), both groups showed an average drop of 1.5 points. When looking at how many participants reached a low "remission" score on the MADRS (a score of 12 or below), the reported data shows 48 people in the ziprasidone group and 54 in the placebo group reached that level. For what the researchers called a "response" (a drop of 50% or more in their MADRS score), 62 people in the ziprasidone group and 65 in the placebo group met that threshold. The reported data also shows that, on a clinician-rated global improvement scale (CGI-I), 66 participants in the ziprasidone group and 69 in the placebo group were rated as "much improved" or "very much improved" at week 6. Earlier time points during the 6 weeks showed smaller score reductions in both groups, gradually increasing toward the week 6 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00129220 · results posted 15 February 2010
According to the results reported on ClinicalTrials.gov, this trial compared three groups of people experiencing manic episodes related to bipolar disorder: those taking olanzapine (105 started), those taking haloperidol (20 started), and those taking a placebo — an inactive dummy pill (99 started). The trial used a rating scale called the Young Mania Rating Scale (YMRS), which scores the severity of manic symptoms from 0 (no symptoms) to 60 (extremely severe). The main thing the trial was measuring was how much participants' YMRS scores changed over three weeks. A number of participants did not complete the full study across both periods. The reported data shows that at the three-week mark, the average YMRS score fell by 12.6 points in the olanzapine group, 14.3 points in the haloperidol group, and 6.8 points in the placebo group. At six weeks, the reported average drops were 16.0 points for olanzapine, 14.7 points for haloperidol, and 10.1 points for placebo. The trial also measured how many participants met criteria for "remission" (defined as reaching low scores on both the mania and depression rating scales by week six): 44.2% of the olanzapine group and 20.0% of the haloperidol group met that definition. For "response" — meaning at least a 50% reduction in their mania score — the reported figures at six weeks were 67.3% for olanzapine, 65.0% for haloperidol, and 55.7% for placebo. Separate rating scales measuring overall illness severity and manic symptoms also showed score reductions across all three groups, with the exact numbers varying by group and 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00303602 · results posted 2 June 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 149 people across two groups: 84 in one group (called SODO) and 65 in the other (called SOT). The trial tracked changes in body size measurements — mainly Body Mass Index (BMI, a number calculated from height and weight), body weight, and waist circumference — over 16 weeks. Not everyone finished the trial: 65 people in the SODO group and 50 in the SOT group completed it. The reported data shows that both groups gained a small amount of BMI over the 16 weeks. The SODO group's BMI increased by an average of 0.52 kg/m² from the start to the end, while the SOT group's BMI increased by an average of 0.67 kg/m². Average body weight also increased in both groups — by about 1.42 kilograms in the SODO group and about 2.08 kilograms in the SOT group. Waist circumference increased by an average of 1.13 centimetres in the SODO group and 0.77 centimetres in the SOT group. When looking only at people who finished the full 16 weeks, the reported BMI increases were slightly larger: 0.56 kg/m² for SODO and 0.79 kg/m² for SOT. The reported data also shows that very few participants lost a meaningful amount of weight during the study. The number of people who lost at least 5% of their body weight at any point during the trial was low in both groups — reaching a maximum of 4 people in the SODO group and 6 people in the SOT group by the end of the 16-week period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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.