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

NCT ID NCT00365859

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

330 people

The number who actually took part.

Started

Sep 2006

Finished

Jun 2009

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria - Rollover: * Completed 8 weeks of treatment in one of the following double-blind clinical trials: CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\] * No significant protocol violations and sufficient medical justification to continue on open-label treatment with aripiprazole Inclusion Criteria - De Novo: * Meets current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and demonstrates serious behavioral problems - diagnosis confirmed by Autism Diagnostic Interview-Revised (ADI-R) or the patient meets the current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and has a history of behavioral problems that are currently being treated with psychotropic medication * Mental age of at least 18 months * Male or female 6 to 17 years of age, inclusive, at the time of enrollment Exclusion Criteria: * Patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each * Patients previously treated and not responding to aripiprazole treatment * The patient is currently diagnosed with another disorder on the autism spectrum, including pervasive developmental disorder-not otherwise specified (PDD-NOS), Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or Childhood Disintegrative Disorder * Current diagnosis of bipolar disorder, psychosis, schizophrenia, or major depression * A seizure in the past year * History of severe head trauma or stroke * Non-pharmacologic therapy (e.g. psychotherapy, behavior modification) should be stable prior to screening and consistent throughout the study

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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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