Could a new pill tame Autism-Related irritability in kids?

NCT ID NCT06690398

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

First seen Jul 07, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This study tests whether the drug lumateperone can safely reduce irritability in children aged 5 to 17 who have autism spectrum disorder. Participants receive either a high dose, low dose, or placebo daily for several weeks. Researchers measure changes in irritability using a standard behavior checklist.

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 successful, this could provide a new medication option to help manage irritability in children with autism, potentially improving daily functioning and quality of life.
What could go wrong: This is a phase 3 trial, but results may not confirm benefit over placebo. Side effects of lumateperone are possible, and what works in a study may not work for every child in real-world settings.

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

AIM Trials
RECRUITING

Plano, Texas, 75093, United States
Access Clinical Trials
RECRUITING

Nashville, Tennessee, 37203, United States
Advanced Research Center Inc
RECRUITING

Anaheim, California, 92805, United States
Anchor Medical Research LLC
RECRUITING

Miami, Florida, 33176, United States
Buena Park Research
COMPLETED

Upland, California, 91786, United States
CenExeli Research LLC
RECRUITING

Savannah, Georgia, 31405, United States
Charak Center for Health and Wellness
RECRUITING

Garfield, Ohio, 44125, United States
Clinical Research Partners, LLC
RECRUITING

Petersburg, Virginia, 23805, United States
Columbus Clinical Services LLC
SUSPENDED

Miami, Florida, 33125, United States
Diverse Clinical Research LLC
RECRUITING

Miami, Florida, 33175, United States
Excell Research Inc
RECRUITING

Oceanside, California, 92056, United States
Green Leaf Clinical Trials
RECRUITING

Jacksonville, Florida, 32258, United States
Harmonex Neuroscience Research
RECRUITING

Dothan, Alabama, 36303, United States
Health Synergy Clinical Research
RECRUITING

West Palm Beach, Florida, 33407, United States
Inland Psychiatric Medical Group Inc
RECRUITING

Redlands, California, 92373, United States
Kaleidoscope Clinical Research
RECRUITING

Houston, Texas, 77089, United States
Links Clinical Trials
RECRUITING

Miami, Florida, 33176, United States
MCB Clinical Research Centers LLC
COMPLETED

Colorado Springs, Colorado, 80910, United States
Massachusetts General Hospital
COMPLETED

Boston, Massachusetts, 02114, United States
Midwest Research Group
RECRUITING

Saint Charles, Missouri, 63304, United States
Next Level Clinical Trials, LLC
RECRUITING

West Covina, California, 91790, United States
North Pointe Psychiatry
RECRUITING

Flower Mound, Texas, 76028, United States
Northwest Clinical Research Center
RECRUITING

Bellevue, Washington, 98007, United States
Perceptive Pharma Research
RECRUITING

Richmond, Texas, 77407, United States
REX Clinical Trials LLC
RECRUITING

Beaumont, Texas, 77701, United States
Revive Research Institute
RECRUITING

Elgin, Illinois, 60123, United States
Royal Palm Clinical Research
SUSPENDED

Fort Myers, Florida, 33901, United States
Sarkis Clinical Trials
RECRUITING

Gainesville, Florida, 32607, United States
South Florida Research Phase I-IV
RECRUITING

Miami, Florida, 33166, United States
Southern Illinois University School of Medicine
SUSPENDED

Springfield, Illinois, 62701, United States
Southwest Autism Research and Resource Center
RECRUITING

Phoenix, Arizona, 85006, United States
The Angel Medical Research Corporation
RECRUITING

Miami Gardens, Florida, 33169, United States
UMass Memorial Healthcare
RECRUITING

Worcester, Massachusetts, 01655, United States
Vector Clinical Trials
RECRUITING

Las Vegas, Nevada, 89128, United States
Westlake Brain Health
COMPLETED

Westlake, Ohio, 44145, United States

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