Autism behavior drug shows promise in kids

NCT ID NCT00337571

Completed Symptom relief Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether aripiprazole (Abilify) can reduce serious behavioral problems in children and adolescents with autistic disorder. 218 participants aged 6 to 17 received either a fixed dose of aripiprazole or a placebo daily for 8 weeks. The main goal was to see if the drug improved irritability and agitation compared to a placebo.

What this could mean

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

Active substance: aripiprazole (Abilify)
What this could lead to: If successful, this could provide a medication option to help manage severe irritability and behavioral issues in children and teens with autism.
What could go wrong: This is a completed Phase 3 trial, but results may not apply to all individuals with autism. Side effects of aripiprazole can include weight gain, drowsiness, and movement problems.

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Conditions

The condition(s) this trial relates to.

autism Behavioral Symptoms

As listed by the trial registrant

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

AUTISTIC DISORDER BEHAVIORAL SYMPTOMS

Contacts and locations

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Locations

Bayou City Research, Ltd.

Houston, Texas, 77007, United States
Cambridge Health Alliance

Medford, Massachusetts, 02139, United States
Children'S Hospital Of Michigan

Detroit, Michigan, 48201, United States
Children'S Hospital Of Wisconsin

Milwaukee, Wisconsin, 53201, United States
Children'S Mercy Hospital

Kansas City, Missouri, 64108, United States
Children'S National Medical Center

Fairfax, Virginia, 22031, United States
Clinical Innovations, Inc.

Huntington Beach, California, 92647, United States
Cutting Edge Research

Oklahoma City, Oklahoma, 73116, United States
Dallas Pediatric Neurology Associates

Dallas, Texas, 75230, United States
Duke Child And Family Study Center

Durham, North Carolina, 27710, United States
Harmonex Neuroscience

Dothan, Alabama, 36303, United States
Institute For Behavioral Medicine

Smyrna, Georgia, 30080, United States
Ladders Clinic

Wellesley, Massachusetts, 02481, United States
Marsella, Gregory

Boca Raton, Florida, 33432, United States
Mission Hospitals

Asheville, North Carolina, 28801, United States
Munroe-Meyer Institute

Omaha, Nebraska, 68198, United States
North Shore - Long Island Jewish Health System

Bethpage, New York, 11714, United States
Pacific Institute Of Medical Sciences

Bothell, Washington, 98011, United States
Regions Hospital

Saint Paul, Minnesota, 55101, United States
Richmond Behavioral Associates

Staten Island, New York, 10312, United States
Seaver And New York Autism Center Of Excellence

New York, New York, 10029, United States
Southwest Autism Research And Resource Center

Phoenix, Arizona, 85006, United States
Stanford University School Of Medicine

Stanford, California, 94305, United States
The Children'S Hospital

Aurora, Colorado, 80045, United States
The Nisonger Center

Columbus, Ohio, 43210, United States
University Of Alabama At Birmingham

Birmingham, Alabama, 35294, United States
University Of California-Davis Medical Center

Sacramento, California, 95817, United States
University Of Florida

Gainesville, Florida, 32611, United States
University Of Illinois At Chicago

Chicago, Illinois, 60606, United States
University Of South Florida

Tampa, Florida, 33613, United States
Western Psychiatric Institute And Clinic

Pittsburgh, Pennsylvania, 15203, United States

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