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

Major Depressive Disorder Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Clinical Trial 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.

Clinical Trial Description

The study will be conducted in three periods: - Screening Period (up to 2 weeks) during which patient eligibility will be assessed. - Double-blind Treatment Period (6 weeks) in which all patients will be randomized to receive placebo or lumateperone 42 mg/day in 1:1 ratio. - Safety Follow-up Period (1 week) in which all patients will return to the clinic for a safety follow-up visit approximately one week after the last dose of study treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05850689
Study type Interventional
Source Intra-Cellular Therapies, Inc.
Contact ITI Clinical Trials
Phone 646 440-9333
Email ITCIClinicalTrials@itci-inc.com
Status Recruiting
Phase Phase 3
Start date May 2, 2023
Completion date October 2025
View Details
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