Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

Timeline

Start

2024-05-14

Primary completion

2031-10-31

Completion

2031-10-31

Drugs

Indications