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

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).

NCT Number	NCT06372964
Lead Sponsor	Intra-Cellular Therapies, Inc.
Conditions	Bipolar Depression
Enrollment	384 participants
Start Date	2024-05-14
Primary Completion	2031-10-31 (estimated)
Study Completion	2031-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-31