Open-label Phase 3 Study of Lumateperone Safety and Tolerability in Children and Teens With Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder

What this Trial Is About

This research aims to evaluate the safety and tolerability of lumateperone in pediatric patients diagnosed with schizophrenia, bipolar disorder, or autism spectrum disorder. It is a global, multicenter, open-label study lasting 26 weeks. The study includes both new patients and those rolling over from previous lumateperone studies or lead-in efficacy studies. Participants will receive lumateperone capsules or orally disintegrating tablets once daily, with doses ranging from 5 mg to 42 mg, adjusted by age and condition. The study begins with up to a 2-week screening period to confirm eligibility, followed by a 26-week open-label treatment period where all patients receive lumateperone. After the treatment period, there is a 2-week safety follow-up visit to monitor participants after their last dose. During the study, participants will be monitored regularly through clinic visits, where safety and tolerability will be assessed. Researchers will track the incidence of common adverse events throughout the 6-month treatment and follow-up period. Participants must maintain outpatient status during the trial. The total participation duration spans approximately 28 weeks, including screening, treatment, and safety follow-up.

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