Schizophrenia Clinical Trial
Official title:
An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia or Bipolar Disorder
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia or bipolar disorder.
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) Rollover Patients: • Patients with bipolar disorder who are enrolling directly from a lead-in efficacy study. This study will be conducted as follows: - A Screening Period of up to 2 weeks during which patient eligibility will be assessed. - A 26-week Open-label Treatment Period (OLTP) during which all patients will receive open-label lumateperone once daily. - A 2-week Safety Follow-up (SFU) Period: All patients should return to the clinic for the SFU visit approximately 2 weeks after the last dose of open-label lumateperone. ;
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