Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder 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
Intra-Cellular Therapies, Inc.
160 participants
Nov 22, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Lumateperone administered orally once daily
Lumateperone administered orally once daily
Matching Placebo administered orally once daily
Locations(35)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06690398