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

Completed · Phase 1

Conditions studied: Schizophrenia, Pediatric

In brief

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.

Key facts

Study ID

NCT04779177

Run by

Intra-Cellular Therapies, Inc.

People needed

26

Starts

2021-03-12

Expected to finish

2022-07-30

Last updated by the study team

2025-11-12

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Clinical Site — Hollywood, Florida, United States
• Clinical Site — Atlanta, Georgia, United States
• Clinical Site — Decatur, Georgia, United States

Full record on ClinicalTrials.gov

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