Could a new pill ease irritability in kids with autism?

NCT ID NCT06706674

Recruiting now Symptom relief Sponsor: Intra-Cellular Therapies, Inc. Source: ClinicalTrials.gov ↗

First seen Jul 07, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tests whether the drug lumateperone can safely reduce irritability in children aged 5 to 17 with autism spectrum disorder. Participants receive either a high or low dose of lumateperone or a placebo daily. The main goal is to see if the drug improves irritability scores compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: lumateperone
What this could lead to: If effective, lumateperone could offer a new medication option to help manage irritability in children with autism.
What could go wrong: This is a phase 3 trial, but results may not apply to all children. Side effects are possible, and the drug may not work better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IRRITABILITY ASSOCIATED WITH AUTISM SPECTRUM DISORDER

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

AP Medical Research
SUSPENDED

Miami, Florida, 33165, United States
APG Research LLC
RECRUITING

Orlando, Florida, 32803, United States
Advanced Discovery Research
RECRUITING

Atlanta, Georgia, 30318, United States
Advanced Research Institute of Miami
SUSPENDED

Homestead, Florida, 33033, United States
Advantage Clinical Trials
RECRUITING

The Bronx, New York, 10467, United States
Alivation Research LLC
RECRUITING

Lincoln, Nebraska, 68526, United States
Baber Research Group
RECRUITING

Naperville, Illinois, 60563, United States
BioBehavioral Research of Austin PC
RECRUITING

Austin, Texas, 78759, United States
Blue Medical Research
RECRUITING

Miami, Florida, 33144, United States
California Neuroscience Research
RECRUITING

Sherman Oaks, California, 91403, United States
Care Research Center Inc
RECRUITING

Miami, Florida, 33130, United States
Clinical Research Center of Florida
RECRUITING

Pompano Beach, Florida, 33060, United States
Core Clinical Research
RECRUITING

Everett, Washington, 98201, United States
EmVenio Research at Chicago
RECRUITING

Chicago, Illinois, 60622, United States
Future Search Trials of Dallas
COMPLETED

Dallas, Texas, 75251, United States
GTL Medical and Research Group
COMPLETED

Miami, Florida, 33173, United States
Louisiana State University Health Sciences Center Shreveport
RECRUITING

Shreveport, Louisiana, 71101, United States
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States
NYU Child Study Center
RECRUITING

New York, New York, 10016, United States
Nathan Kline Institute
RECRUITING

Orangeburg, New York, 10962, United States
Neurobehavioral Medicine Group
RECRUITING

Bloomfield Hills, Michigan, 48302, United States
New Med Research Inc
RECRUITING

Miami Gardens, Florida, 33056, United States
North Texas Clinical Trials
SUSPENDED

Fort Worth, Texas, 76104, United States
Orlando Psychiatric Associates
COMPLETED

Orlando, Florida, 32809, United States
Pillar Clinical Research, LLC
RECRUITING

Little Rock, Arkansas, 72204, United States
Quest Therapeutics of Avon Lake
RECRUITING

Avon Lake, Ohio, 44012, United States
Red Oak Psychiatry Associates
RECRUITING

Houston, Texas, 77090, United States
Richmond Behavioral Associates
RECRUITING

Staten Island, New York, 10314, United States
Riley Hospital for Children at Indiana University Health
COMPLETED

Indianapolis, Indiana, 46202, United States
Riveldi Biomedical Research
SUSPENDED

Miami Lakes, Florida, 33014, United States
SP Research, PLLC (dba Rivus Wellness & Research Institute)
RECRUITING

Oklahoma City, Oklahoma, 73112, United States
Salveo Integrative Health Inc
RECRUITING

Lawrenceville, Georgia, 30046, United States
Sooner Clinical Research
RECRUITING

Oklahoma City, Oklahoma, 73116, United States
Texas Research Group
RECRUITING

Coppell, Texas, 75019, United States
United Research Institute
RECRUITING

Hialeah, Florida, 33012, United States
University Of California - Davis
RECRUITING

Sacramento, California, 95817, United States
University of South Florida Rothman Center of Neuropsychiatry
RECRUITING

St. Petersburg, Florida, 33701, United States
Virginia Commonwealth University
RECRUITING

Richmond, Virginia, 23220, United States
Vital Care Research
SUSPENDED

Miami, Florida, 33122, United States
Yale University School Of Medicine
RECRUITING

New Haven, Connecticut, 06519, United States

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