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Autism behavior drug shows promise in kids

NCT ID NCT00337571

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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

218 people

The number who actually took part.

Started

Jun 2006

Finished

Jun 2008

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: * 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). * CGI score \> = 4 AND an ABC Irritability/Agitation subscale score \> = 18 at screening and baseline (randomization) * Mental age of at least 18 months * Male or female 6 to 17 years of age inclusive, at the time of randomization 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 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

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

  • 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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