NCT04285515

Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) or Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 488 (actual)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening Period, a Double-blind Treatment Period, and a Safety Follow-up Period.

Conditions

• Bipolar Depression
• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Lumateperone	Lumateperone 42mg oral capsule
DRUG	Placebos	Placebo oral capsule

Timeline

• Start date: 2020-02-27
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2020-02-26
• Last updated: 2025-03-19
• Results posted: 2025-03-19

Locations

42 sites across 5 countries: United States, Bulgaria, Russia, Serbia, Ukraine

Regulatory

• FDA-regulated drug study