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Depressive Disorder, Major / Lumateperone · Phase 3 Trial
ClinicalTrials.gov · August 5, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 3 trial comparing two doses of lumateperone against placebo in major depressive disorder, with primary endpoint of MADRS change at 6 weeks. The study has not yet begun recruitment and no results are available in this registry record.
Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Depressive Disorder, Major; age from 18 Years; to 74 Years. Intervention: Lumateperone: Dose 1; Lumateperone: Dose 2. Compared with: Placebo — Placebo Comparator. n = 585.
This is a registered Phase 3 trial comparing two doses of lumateperone against placebo in major depressive disorder, with primary endpoint of MADRS change at 6 weeks. The study has not yet begun recruitment and no results are available in this registry record.
Study has not yet started recruitment; no efficacy or safety results are reported.
The source did not state who this applies to in practice.
This is an unstarted Phase 3 registration with no results posted; it describes a planned trial design and primary outcome measure only.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07747389). This is a study registration, not published results. Lead sponsor: Intra-Cellular Therapies, Inc.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 585 participants (ESTIMATED). Conditions: Depressive Disorder, Major. Interventions: DRUG: Lumateperone; DRUG: Placebo. Primary outcome measures: Change from DB Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Week 6 , DB Baseline (Day 1) up to Week 6. Brief 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).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.