NCT04779177

Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder

An Open-label Multiple Oral Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lumateperone in Patients, Ages 13 to 17 Years, Diagnosed With Schizophrenia or Schizoaffective Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Study ITI-007-020 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone as treatment for adolescent patients with schizophrenia or schizoaffective disorder.

Conditions

• Schizophrenia
• Pediatric

Interventions

Type	Name	Description
DRUG	Lumateperone 42 mg	Lumateperone 42 mg, oral administration
DRUG	Lumateperone 28 mg	Lumateperone 28 mg, oral administration

Timeline

• Start date: 2021-03-12
• Primary completion: 2022-07-30
• Completion: 2022-07-30
• First posted: 2021-03-03
• Last updated: 2025-11-12
• Results posted: 2025-11-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study