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).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Bipolar Depression

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

10 to 17 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Intra-Cellular Therapies, Inc.

Last updated on ClinicalTrials.gov

September 25, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites