HomeTrialNCT06372964
🔬NCT06372964Phase 3RECRUITING

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

Study 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).

Interventions / Drugs
View on ClinicalTrials.gov ↗
Study Details
Enrollment384 participants
Primary Completion
Lead SponsorIntra-Cellular Therapies, Inc.
Data Retrieved2026-04-11 04:18:13.264809+00:00
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