Phase 4 Depression and Anxiety Trial, Not Yet Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility 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
Who may be able to join
- People who are able to give written consent to participate before any study procedures begin, and who are able to provide that consent independently.
- People who are male or female, aged between 21 and 70 years old (inclusive).
- People who have been diagnosed with Major Depressive Disorder (a serious form of depression) without psychotic symptoms, confirmed using a structured clinical interview tool.
- People whose depression severity score on a standard rating scale (called the MADRS) is 28 or above at both the screening visit and the baseline visit.
- People who report having experienced at least one episode of physical or sexual assault before the age of 16, as confirmed through an interview-based assessment.
- People who have been taking the same dose of an antidepressant medication for at least 6 weeks, with less than 50% improvement in their symptoms, and who are willing to stay on that same dose throughout the entire study, at or above the minimum recognised effective dose (confirm with trial site).
- Women who could become pregnant must agree to use at least one acceptable form of contraception from the time of consent through the end of the study follow-up period (women who are permanently sterilised or post-menopausal for at least one year are exempt from this requirement).
- People who are able to follow study instructions and are likely to attend all required visits.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who currently have a primary psychiatric diagnosis other than Major Depressive Disorder, including PTSD, OCD, Bipolar Disorder, Schizophrenia, schizoaffective disorder, other psychotic disorders, intellectual disability, dementia or other thinking and memory disorders, or a moderate to severe substance use disorder (not including nicotine).
- People who, in the investigator's judgement, are at significant risk of suicidal behaviour during the study.
- People who, within the 6 months before screening, have reported certain types of serious suicidal thoughts as measured by a standard safety questionnaire (called the C-SSRS).
- People who have made a suicide attempt within the 1 year before the screening visit.
- People who report certain types of serious suicidal thoughts on the C-SSRS between the screening visit and the baseline visit.
- People who score 4 or higher on the suicidal thoughts item of the MADRS rating scale at either the screening or baseline visit.
- People who are considered to be in immediate danger of harming themselves or others.
- People for whom MRI scans are not safe, such as those with shrapnel, metal implants, electronic implants (such as pacemakers), aneurysm clips, ferrous surgical devices, or metallic tattoos on the head in their body.
- People who have received electroconvulsive therapy (ECT), vagal nerve stimulation, or repetitive transcranial magnetic stimulation within the past year.
- People who have a known allergy or sensitivity to the study drug (lumateperone) or any of its ingredients.
- People who have received a long-acting injectable antipsychotic medication within one dosing cycle before the screening visit.
- People who are currently taking certain medications that must be stopped at screening, including specific drugs that affect how the body processes medications (moderate or strong CYP3A4 inhibitors or inducers), certain opioid-related medications including tramadol, and dietary supplements or medical foods not approved by the study sponsor (a daily standard multivitamin is permitted).
- People who have taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI) within 14 days before the baseline visit.
- People taking other medications with known or potentially significant effects on the brain or nervous system (confirm with trial site).
- People who plan to start a new type of talking therapy (psychotherapy) or make changes to their current psychotherapy during the study (people already in stable psychotherapy may still be eligible).
- People who have previously taken part in a clinical trial of lumateperone, or who have taken any other investigational (experimental) medication within 6 months before the baseline visit, or who have taken part in more than 2 clinical studies of an experimental medication for a brain or mental health condition.
- People who are pregnant or breastfeeding, or women of childbearing potential who do not have a negative pregnancy test at screening and at the baseline visit.
- People who test positive for alcohol or drugs of abuse (such as amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, methadone, or opioids) at the screening visit.
- People with certain abnormal blood test results at screening, including liver enzyme levels more than twice the upper limit of normal, elevated bilirubin, low haemoglobin (below certain levels for males and females), low white blood cell counts, thyroid hormone levels outside the normal range, poorly controlled diabetes, or evidence of hepatitis B or C infection.
- People with a heart trace (ECG) showing a corrected heart rhythm interval (QTcF) above 450 milliseconds for males or 470 milliseconds for females, a heart rate below 50 beats per minute, or significant abnormalities in the electrical conduction of the heart.
- People with certain serious or unstable medical conditions, including: uncontrolled chest pain (angina) or a heart attack within the past 3 months, a history of significant abnormal heart rhythms or other heart disorders; a cancer diagnosis (other than certain skin cancers) unless in remission for at least 5 years; a history of gastric bypass surgery or other conditions affecting how the body absorbs medication; untreated or unstable thyroid disorders, or unstable diabetes; hepatitis B or C, or moderate to severe liver disease; diagnosed but untreated obstructive sleep apnoea; a history of epilepsy, seizures, significant brain injury, movement disorders, dementia, delirium, or other serious neurological conditions; or a history of HIV infection.
- People who the investigator considers to be unsuitable for the study for any other reason.
- People who are currently homeless.
- People who do not speak English.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Phone: 512-495-5566
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
The primary efficacy endpoint is the absolute change in Montgomery-Åsberg Depression Rating Scale (MADRS) total scores from Baseline to end of Treatment visit at Week 6 in subjects on ADT plus Lumateperone or matching placebo.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.