Recruiting PHASE3 INTERVENTIONAL 1-arm NCT06229210

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

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

Sponsor: Intra-Cellular Therapies, Inc.

Conditions Autism Spectrum Disorder Bipolar Disorder Schizophrenia

Interventions Lumateperone

Updated 4 times since 2024 Last updated: Jul 7, 2025 Started: Jan 25, 2024 Primary completion: Dec 31, 2027 Completion: Dec 31, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Autism Spectrum Disorder and Bipolar Disorder, this trial is actively recruiting participants. The trial is conducted by Intra-Cellular Therapies, Inc. and has accumulated 4 data snapshots since 2024. Psychiatric clinical trials are essential for establishing evidence-based treatment standards.

Status Flow

Change History

4 versions recorded

Aug 2025 — Present [monthly]

Recruiting PHASE3
Sep 2024 — Aug 2025 [monthly]

Recruiting PHASE3
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE3
Feb 2024 — Jul 2024 [monthly]

Recruiting PHASE3

First recorded

Jan 2024

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Intra-Cellular Therapies, Inc.

Data source: Intra-Cellular Therapies, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Anaheim, United States , Atlanta, United States , Avon Lake, United States , Belgrade, Serbia , Bellevue, United States , Bloomfield Hills, United States , Cincinnati, United States , Colorado Springs, United States , Colton, United States , Decatur, United States and 32 more locations