A Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder (NCT07747389) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder
585 participantsStarted 2026-10-20
Plain-language summary
The purpose of the study is to assess how well each dose of lumateperone (Dose 1 and 2) works when given alone as compared to placebo in participants with major depressive disorder (MDD; a medical condition characterized by a persistent feeling of deep sadness, hopelessness, and a loss of interest in activities for a prolonged period of time and interfere with ability to function).
Who can participate
Age range
18 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and where applicable at DB period baseline
* Medically stable based on clinical laboratory tests performed at screening and where applicable at DB period baseline
* Meets the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnostic criteria for recurrent or single episode MDD, without psychotic features, based upon clinical assessment and confirmed by Structured Clinical Interview for DSM-5 Axis I Disorders - Clinical Trials Version (SCID-CT)
* Has moderate-to-severe depression as measured by a rater-administered MADRS total greater than or equal to (\>=) 26 score and corresponding to a CGI-S score of \>=4 at screening and DB baseline
* Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score of \>=15 at screening and DB baseline
Exclusion criteria:
* The participant experiences a \>=25 percent (%) decrease in the MADRS total score between screening and DB baseline
* The participant experiences a \>=25% decrease in the QIDS-SR-16 total score between screening and DB baseline
* Has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the screening period, per the investigator's clinical judgment or based on the Columbia-Suicide Severity Rating Scale (C-SSRS…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing lumateperone specifically for major depressive disorder — can you explain how lumateperone works differently from antidepressants I might already be familiar with, and whether that difference matters for my situation?
2Since this is a Phase 3 trial comparing lumateperone to a placebo, what does that mean about what's already known — and unknown — about its safety and effectiveness for depression at this stage?
3The trial hasn't started recruiting yet, so realistically how long might it be before I could even enroll, and in the meantime should I be considering standard antidepressant treatments instead?
4The main thing being measured is change in depression symptoms on a rating scale called the MADRS over six weeks — is six weeks a realistic timeframe to expect meaningful relief, and how does that compare to how standard treatments work?
5Given that this trial involves a placebo group, meaning I might not receive the actual medication, would you recommend I try established depression treatments first, or do you think this trial could still be worth discussing as an option for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from DB Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Week 6