Clinical Trial

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

Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2023-04-29; most recent amendment 2026-07-22.
Trial Details
NCT Number NCT05850689
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Major Depressive Disorder
Enrollment 470 participants
Start Date 2023-05-02
Primary Completion 2027-04-05 (estimated)
Study Completion 2027-04-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-31