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

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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)

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. ;

Related Conditions & MeSH terms

• Bipolar Disorder
• Schizophrenia

• NCT number: NCT06229210
• Study type: Interventional
• Source: Intra-Cellular Therapies, Inc.
• Contact: ITI Clinical Trials
• Phone: 646 440-9333
• Email: ITCIClinicalTrials@itci-inc.com
• Status: Recruiting
• Phase: Phase 3
• Start date: January 25, 2024
• Completion date: December 2027