Clinical Trial

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

Recruiting Phase 3
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Summary
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-01-19; most recent amendment 2026-07-02.
Trial Details
NCT Number NCT06229210
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder
Enrollment 300 participants
Start Date 2024-01-25
Primary Completion 2032-04-28 (estimated)
Study Completion 2032-04-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-13