A Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder

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).

NCT Number	NCT07747389
Lead Sponsor	Intra-Cellular Therapies, Inc.
Conditions	Depressive Disorder, Major
Enrollment	585 participants
Start Date	2026-10-20
Primary Completion	2029-09-20 (estimated)
Study Completion	2029-09-20 (estimated)
Updated on ClinicalTrials.gov	2026-08-05