NCT07747389Not yet recruitingPhase 3
A Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Fixed Doses of Lumateperone Administered as Monotherapy in Participants With Major Depressive Disorder and an Open-label Long-term Extension Treatment With Lumateperone
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 585 (estimated)
- First submitted
- 30 Jul 2026
- Start date
- 11 Nov 2026
- Primary completion date
- 20 Sept 2029
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Diseases
- Depression
- NCT number
- NCT07747389
- EU CT number
- 2026-525307-27-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 585
- From 11 Nov 2026 to the primary completion date, 20 Sept 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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), corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C-SSRS, or a history of suicidal behavior within the past 6 months prior to the start of the screening period
- Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening
- Has a history or evidence of clinically meaningful noncompliance with antidepressant therapy (ADT)s
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 74 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.