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

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Major Depressive Disorder

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

18 to 65 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Intra-Cellular Therapies, Inc.

Last updated on ClinicalTrials.gov

September 25, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites