An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder
Intra-Cellular Therapies, Inc.
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.
Description
The study will enroll pediatric patients as follows: De Novo Patients: * Patients with schizophrenia, including patients who have previously participated in the lumateperone open-label pediatric pharmacokinetic (PK) study (Study ITI-007-020) * Patients with bipolar disorder who have previously participated in the lumateperone open-label pediatric PK study (Study ITI-007-030) * Patients with irritability associated with autism spectrum disorder who have previously participated in the lumateperone open-label pediatric PK study (Study ITI-007-035) Rollover Patients: * Patients with bipolar di…