NCT06690398From ClinicalTrials.govRecruiting

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

Irritability Associated With Autism Spectrum Disorder

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Intra-Cellular Therapies, Inc.
Enrolment target: 160
Started: 22 November 2024
Main results due: 21 June 2027
Study sites: 35
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 (C-SSRS) 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(35)

Harmonex Neuroscience Research
Dothan, Alabama, United States
Recruiting
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States
Recruiting
Advanced Research Center Inc
Anaheim, California, United States
Recruiting
Excell Research Inc
Oceanside, California, United States
Recruiting
Inland Psychiatric Medical Group Inc
Redlands, California, United States
Recruiting
Buena Park Research
Upland, California, United States
Completed
Next Level Clinical Trials, LLC
West Covina, California, United States
Recruiting
MCB Clinical Research Centers LLC
Colorado Springs, Colorado, United States
Completed
Royal Palm Clinical Research
Fort Myers, Florida, United States
Suspended
Sarkis Clinical Trials
Gainesville, Florida, United States
Recruiting
Green Leaf Clinical Trials
Jacksonville, Florida, United States
Recruiting
Columbus Clinical Services LLC
Miami, Florida, United States
Recruiting
South Florida Research Phase I-IV
Miami, Florida, United States
Recruiting
Diverse Clinical Research LLC
Miami, Florida, United States
Recruiting
Anchor Medical Research LLC
Miami, Florida, United States
Recruiting
Links Clinical Trials
Miami, Florida, United States
Recruiting
The Angel Medical Research Corporation
Miami Gardens, Florida, United States
Recruiting
Health Synergy Clinical Research
West Palm Beach, Florida, United States
Recruiting
CenExeli Research LLC
Savannah, Georgia, United States
Recruiting
Revive Research Institute
Elgin, Illinois, United States
Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Suspended
Massachusetts General Hospital
Boston, Massachusetts, United States
Completed
UMass Memorial Healthcare
Worcester, Massachusetts, United States
Recruiting
Midwest Research Group
Saint Charles, Missouri, United States
Recruiting
Vector Clinical Trials
Las Vegas, Nevada, United States
Recruiting
Charak Center for Health and Wellness
Garfield, Ohio, United States
Recruiting
Westlake Brain Health
Westlake, Ohio, United States
Completed
Access Clinical Trials
Nashville, Tennessee, United States
Recruiting
REX Clinical Trials LLC
Beaumont, Texas, United States
Recruiting
North Pointe Psychiatry
Flower Mound, Texas, United States
Completed
Kaleidoscope Clinical Research
Houston, Texas, United States
Recruiting
AIM Trials
Plano, Texas, United States
Recruiting
Perceptive Pharma Research
Richmond, Texas, United States
Recruiting
Clinical Research Partners, LLC
Petersburg, Virginia, United States
Recruiting
Northwest Clinical Research Center
Bellevue, Washington, United States
Recruiting

Showing 35 of 35 sites. 28 of the 35 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 NCT06690398. 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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