NCT06706674From ClinicalTrials.govRecruiting

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

Irritability Associated With Autism Spectrum Disorder

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Intra-Cellular Therapies, Inc.
Enrolment target: 160
Started: 6 December 2024
Main results due: 21 June 2027
Study sites: 40
Registry updated: 25 September 2026

Can you take part?

Ages 5 years to 17 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

1. All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits.
2. Able to provide consent as follows:

1. The patient's LAR must provide written, informed consent.
2. When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
3. Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
4. Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
5. ABC-I subscale score of \>18 at Screening and Baseline;
6. CGI-S score \> 4 with respect to irritability associated with ASD at Screening and Baseline.

Exclusion Criteria:

1. Has a primary psychiatric diagnosis other than ASD. Exceptions include:

1. Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.
2. Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).
2. History or current diagnosis of Rett syndrome or Fragile X syndrome;
3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or

1. At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (CSSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
3. The patient is considered to be an imminent danger to themselves or others.

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(40)

Pillar Clinical Research, LLC
Little Rock, Arkansas, United States
Recruiting
University Of California - Davis
Sacramento, California, United States
Recruiting
California Neuroscience Research
Sherman Oaks, California, United States
Recruiting
Yale University School Of Medicine
New Haven, Connecticut, United States
Recruiting
United Research Institute
Hialeah, Florida, United States
Recruiting
Advanced Research Institute of Miami
Homestead, Florida, United States
Suspended
Vital Care Research
Miami, Florida, United States
Suspended
Care Research Center Inc
Miami, Florida, United States
Recruiting
Blue Medical Research
Miami, Florida, United States
Recruiting
AP Medical Research
Miami, Florida, United States
Recruiting
GTL Medical and Research Group
Miami, Florida, United States
Completed
New Med Research Inc
Miami Gardens, Florida, United States
Recruiting
Riveldi Biomedical Research
Miami Lakes, Florida, United States
Suspended
APG Research LLC
Orlando, Florida, United States
Recruiting
Orlando Psychiatric Associates
Orlando, Florida, United States
Completed
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Recruiting
University of South Florida Rothman Center of Neuropsychiatry
St. Petersburg, Florida, United States
Recruiting
Advanced Discovery Research
Atlanta, Georgia, United States
Completed
Salveo Integrative Health Inc
Lawrenceville, Georgia, United States
Completed
EmVenio Research at Chicago
Chicago, Illinois, United States
Recruiting
Baber Research Group
Naperville, Illinois, United States
Recruiting
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
Completed
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, United States
Recruiting
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States
Recruiting
Alivation Research LLC
Lincoln, Nebraska, United States
Recruiting
NYU Child Study Center
New York, New York, United States
Suspended
Nathan Kline Institute
Orangeburg, New York, United States
Recruiting
Richmond Behavioral Associates
Staten Island, New York, United States
Recruiting
Advantage Clinical Trials
The Bronx, New York, United States
Recruiting
Quest Therapeutics of Avon Lake
Avon Lake, Ohio, United States
Completed
SP Research, PLLC (dba Rivus Wellness & Research Institute)
Oklahoma City, Oklahoma, United States
Recruiting
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Recruiting
Medical University of South Carolina
Charleston, South Carolina, United States
Recruiting
BioBehavioral Research of Austin PC
Austin, Texas, United States
Completed
Texas Research Group
Coppell, Texas, United States
Recruiting
Future Search Trials of Dallas
Dallas, Texas, United States
Completed
North Texas Clinical Trials
Fort Worth, Texas, United States
Recruiting
Red Oak Psychiatry Associates
Houston, Texas, United States
Completed
Virginia Commonwealth University
Richmond, Virginia, United States
Recruiting
Core Clinical Research
Everett, Washington, United States
Recruiting

Showing 40 of 40 sites. 27 of the 40 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06706674. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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