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Study identifier: NCT06706674 Synced from ClinicalTrials.gov · August 02, 2026
● Recruiting

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

Condition: Irritability Associated With Autism Spectrum Disorder  ·  Sponsor: Intra-Cellular Therapies, Inc.

PhasePhase 3
Planned participants160
Who can joinAll sexes, 5 Years to 17 Years
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Study Contact  ·  844-434-4210  ·  Participate-In-This-Study1@its.jnj.com

Always discuss trial participation with your own doctor first.

Locations (40)

Pillar Clinical Research, LLCLittle Rock, Arkansas, United StatesRecruiting
University Of California - DavisSacramento, California, United StatesRecruiting
California Neuroscience ResearchSherman Oaks, California, United StatesRecruiting
Yale University School Of MedicineNew Haven, Connecticut, United StatesRecruiting
United Research InstituteHialeah, Florida, United StatesRecruiting
Advanced Research Institute of MiamiHomestead, Florida, United StatesSuspended
Vital Care ResearchMiami, Florida, United StatesSuspended
Care Research Center IncMiami, Florida, United StatesRecruiting
Blue Medical ResearchMiami, Florida, United StatesRecruiting
AP Medical ResearchMiami, Florida, United StatesSuspended
GTL Medical and Research GroupMiami, Florida, United StatesCompleted
New Med Research IncMiami Gardens, Florida, United StatesRecruiting

+ 28 more locations — full list on the registry record.

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