Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Study Summary

This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.

Conditions

Major Depressive Disorder

Interventions / Drugs

Lumateperone Placebo

View on ClinicalTrials.gov ↗

Sponsor

ITCI

Intra-Cellular Therapies

Neuroscience

F29/100

Study Details

Enrollment470 participants

Primary Completion—

Lead SponsorIntra-Cellular Therapies, Inc.

Data Retrieved2026-04-11 04:18:13.264707+00:00

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