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

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Irritability Associated With Autism Spectrum Disorder

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

5 to 17 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Intra-Cellular Therapies, Inc.

Last updated on ClinicalTrials.gov

September 25, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites