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

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.

Timeline

Start

2020-02-27

Primary completion

2022-11-30

Completion

2022-11-30

Publications

• Durgam S, Kozauer SG, Earley WR, Chen C, Huo J, Lakkis H, Stahl S, McIntyre RS. Lumateperone for the Treatment of Major Depressive Disorder With Mixed Features or Bipolar Depression With Mixed Features: A Randomized Placebo-Controlled Trial. J Clin Psychopharmacol. 2025 Mar-Apr 01;45(2):67-75. doi: 10.1097/JCP.0000000000001964. Epub 2025 Feb 14.

Drugs

Indications