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

NCT07747389 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 585

Last updated 2026-08-05

No results posted yet for this study

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).

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Lumateperone

Participants will receive lumateperone orally.

DRUG

Placebo

Participants will receive placebo orally.

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Principal Investigators

  • Intra-Cellular Therapies, Inc. Clinical Trial · Intra-Cellular Therapies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-20
Primary Completion
2029-09-20
Completion
2029-09-20
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07747389 on ClinicalTrials.gov