Can a year of aripiprazole be safe for kids with autism?

NCT ID NCT00365859

Completed Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This study tests whether aripiprazole, a medication already used for behavioral symptoms, remains safe and tolerable for children and adolescents with autistic disorder when taken daily for up to a year. Most participants will have already completed a short-term trial of the drug. The focus is on tracking side effects, including movement problems, weight changes, and metabolic effects, to see if long-term use is acceptable.

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), an oral tablet taken once daily
What this could lead to: If successful, this trial could confirm that aripiprazole is a safe option for managing behavioral symptoms in children and adolescents with autism over a full year of use.
What could go wrong: This is an open-label study without a placebo group, so results may be biased. The trial focuses on safety, not effectiveness, and side effects like weight gain or movement issues could limit its use.

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 Behavioral Symptoms Problem Behavior

As listed by the trial registrant

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

AUTISTIC DISORDER BEHAVIORAL SYMPTOMS

Contacts and locations

Locations

Autism Spectrum Treatment and Research Center

Seattle, Washington, 98109, United States
Bayou City Research, Ltd.

Houston, Texas, 77007, United States
Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States
Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States
Child Neurology Associates, PC

Atlanta, Georgia, 30342, United States
Children's Developmental Center

Winter Park, Florida, 32792, United States
Children's Hospital Of Michigan

Detroit, Michigan, 48201, United States
Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Children's Mercy Hospital and Clinics

Kansas City, Missouri, 64108-4619, United States
Children's National Medical Center

Fairfax, Virginia, 22031, United States
Children's Specialized Hospital

Toms River, New Jersey, 08755, United States
Clinical Innovations, Inc

Costa Mesa, California, 92626, 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, 30080-6342, United States
Kansas University Medical Center

Kansas City, Kansas, 66160, United States
Ladders Clinic

Wellesley, Massachusetts, 02481, United States
Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States
Miami Children's Hospital

Miami, Florida, 33155, United States
Mission Hospitals - Mission Children's Clinics

Asheville, North Carolina, 22801, United States
Monarch Research Associates

Norfolk, Virginia, 23510, United States
Munroe-Meyer Institute Diagnostic Center

Omaha, Nebraska, 68198-5380, United States
Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, 48302, United States
Neuroscience, Inc

Herndon, Virginia, 20170, United States
North San Antonio Healthcare Associates

San Antonio, Texas, 78218, United States
North Shore - Long Island Jewish Health System

Bethpage, New York, 11714, United States
Offices of Gregory Marsella, MD, PA

Boca Raton, Florida, 33432, United States
Pacific Institute of Medical Sciences

Bothell, Washington, 98034, United States
Peninsula Research Assoc

Rolling Hills Estates, California, 90274, United States
Red Oak Psychiatry Associates, PA

Houston, Texas, 77090, United States
Regions Hospital

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

Staten Island, New York, 10312, United States
SUNY at Stony Brook - School of Medicine

Stony Brook, New York, 11794-8790, United States
Sarkis Clinical Trials

Gainesville, Florida, 32607, United States
Seaver and New York Autism Center of Excellence

New York, New York, 10029, United States
Sharp Mesa Vista Hospital

San Diego, California, 92123, United States
Southwest Autism Research and Resource Center

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

Stanford, California, 94305-5719, United States
The Children's Hospital

Aurora, Colorado, 80045, United States
The Nisonger Center

Columbus, Ohio, 43210, United States
UT Medical Group, Department Of Psychiatry

Memphis, Tennessee, 38105, United States
Univ of Arizona

Tucson, Arizona, 85724-5002, United States
University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States
University Of California-Davis Health Science Center

Sacramento, California, 95817, United States
University of Alabama at Birmingham

Birmingham, Alabama, 35203, United States
University of Cincinnati

Cincinnati, Ohio, 45267-0559, United States
University of Florida

Gainesville, Florida, 32611, United States
University of Illinois at Chicago

Chicago, Illinois, 60608, United States
University of Louisville

Louisville, Kentucky, 40202, United States
University of NC

Chapel Hill, North Carolina, 27599-7160, United States
University of South Florida

Tampa, Florida, 33613, United States
Virginia Treatment Center For Children

Richmond, Virginia, 23298, United States
Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15203, United States

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