Recruiting PHASE3 INTERVENTIONAL 3-arm NCT06706674

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age

Sponsor: Intra-Cellular Therapies, Inc.

Conditions Irritability Associated With Autism Spectrum Disorder

Interventions Lumateperone high dose Lumateperone low dose Placebo

Updated 4 times since 2024 Last updated: Jul 3, 2025 Started: Dec 6, 2024 Primary completion: Mar 31, 2027 Completion: Apr 30, 2027

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

This PHASE3 trial investigates Irritability Associated With Autism Spectrum Disorder and is currently actively recruiting participants. Intra-Cellular Therapies, Inc. leads this study, which shows 4 recorded versions since 2024 — indicating limited longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.

Status Flow

Change History

4 versions recorded

Sep 2025 — Present [monthly]

Recruiting PHASE3
Aug 2025 — Sep 2025 [monthly]

Recruiting PHASE3
Feb 2025 — Aug 2025 [monthly]

Recruiting PHASE3
Dec 2024 — Feb 2025 [monthly]

Recruiting PHASE3

First recorded

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

Atlanta, United States , Austin, United States , Avon Lake, United States , Bloomfield Hills, United States , Boston, United States , Charleston, United States , Coppell, United States , Dallas, United States , Evansville, United States , Everett, United States and 24 more locations