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Study identifier: NCT06690398 Synced from ClinicalTrials.gov · August 02, 2026
● Recruiting

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder 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 (35)

Harmonex Neuroscience ResearchDothan, Alabama, United StatesRecruiting
Southwest Autism Research and Resource CenterPhoenix, Arizona, United StatesRecruiting
Advanced Research Center IncAnaheim, California, United StatesRecruiting
Excell Research IncOceanside, California, United StatesRecruiting
Inland Psychiatric Medical Group IncRedlands, California, United StatesRecruiting
Buena Park ResearchUpland, California, United StatesCompleted
Next Level Clinical Trials, LLCWest Covina, California, United StatesRecruiting
MCB Clinical Research Centers LLCColorado Springs, Colorado, United StatesCompleted
Royal Palm Clinical ResearchFort Myers, Florida, United StatesSuspended
Sarkis Clinical TrialsGainesville, Florida, United StatesRecruiting
Green Leaf Clinical TrialsJacksonville, Florida, United StatesRecruiting
Columbus Clinical Services LLCMiami, Florida, United StatesRecruiting

+ 23 more locations — full list on the registry record.

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