NCT05850689

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 470 (estimated)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Lumateperone	Lumateperone 42 mg capsules administered orally, once daily
DRUG	Placebo	Matching capsules administered orally, once daily

Timeline

• Start date: 2023-05-02
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2023-05-09
• Last updated: 2025-07-01

Locations

60 sites across 7 countries: United States, Bulgaria, France, India, Lithuania, Serbia, Spain

Regulatory

• FDA-regulated drug study