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Can a common drug tame severe autism behaviors in kids?

NCT ID NCT00332241

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 teens aged 6 to 17 with autistic disorder. 98 participants received either the drug or a placebo for 8 weeks. Researchers measured changes in irritability and overall improvement using standard behavior checklists.

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 it works, this could provide a medication option to reduce severe irritability and behavioral issues in children and teens with autism.
What could go wrong
This is an 8-week study with only 98 participants, so long-term effects and broader benefits are unknown. Side effects from aripiprazole are possible.

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

98 people

The number who actually took part.

Started

Jun 2006

Finished

Apr 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 for Mental Disorders-Fourth Edition (DSM-IV) diagnostic criteria for AD and demonstrates serious behavioral problems. Diagnosis confirmed by Autism Diagnostic Interview- Revised (ADI-R) * CGI score \> = 4 AND and Aberrant Behavior Checklist (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, or schizophrenia, or major depression * A seizure in the past year * History of severe head trauma or stroke * Patients undergoing non-pharmacologic therapies (e.g., psychotherapy, behavioral modification) must have started at least 2 months prior to the initial screening visit and must remain in a consistent treatment program for the duration of the study.

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Conditions

The condition(s) this trial relates to.

autism Problem Behavior

As listed by the trial registrant

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

Autistic disorder

Contacts and locations

Locations

  • Center For Psychiatry And Behavioral Medicine

    Las Vegas, Nevada, 89128, United States

  • Child Neurology Associates, Pc

    Atlanta, Georgia, 30342, United States

  • Marsella, Gregory

    Boca Raton, Florida, 33432, United States

  • Neurobehavioral Medicine Group

    Bloomfield Hills, Michigan, 48302, United States

  • Red Oak Psychiatry Associates, Pa

    Houston, Texas, 77090, United States

  • Suny - Stony Brook School Of Medicine

    Stony Brook, New York, 11794, United States

  • Univ Of Nc

    Chapel Hill, North Carolina, 27599, United States

  • University Of Louisville

    Louisville, Kentucky, 40202, United States

  • Ut Medical Group

    Memphis, Tennessee, 38105, United States

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