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Autistic DisorderPhase 3NCT00332241

Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD).

A Phase 3 study testing Aripiprazole in people with Autistic Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD). Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Autistic Disorder
What is being tested?
Aripiprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
9 sitesUnited States
Study dates
1 Jun 2006to 1 Apr 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Child Neurology Associates, Pc

    Atlanta, Georgia, 30342

  • Neurobehavioral Medicine Group

    Bloomfield Hills, Michigan, 48302

  • Marsella, Gregory

    Boca Raton, Florida, 33432

  • Univ Of Nc

    Chapel Hill, North Carolina, 27599

  • Red Oak Psychiatry Associates, Pa

    Houston, Texas, 77090

  • Center For Psychiatry And Behavioral Medicine

    Las Vegas, Nevada, 89128

  • University Of Louisville

    Louisville, Kentucky, 40202

  • Ut Medical Group

    Memphis, Tennessee, 38105

  • Suny - Stony Brook School Of Medicine

    Stony Brook, New York, 11794

Other trials in United States

About this study

Official title: A Multicenter Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder (AD)

This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).

Being tested
Aripiprazole, Placebo
Keywords
Serious behavioral problems in children and adolescents with AD, Behavioral Problems
Medical subject headings
Autistic Disorder, Problem Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AripiprazoleDrug

    Also called Abilify

    Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks

  • PlaceboDrug

    Tablets, Oral, once daily, 8 weeks

Study groups in NCT00332241
Study groupRoleWhat they receive
A1ExperimentalActive Abilify
Receives: Drug: Aripiprazole
A2Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score

    The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement.

    Measured: Week 8

Secondary outcomes (7)

  1. Mean Clinical Global Impressions Improvement Scale (CGI-I) Score

    The CGI scale is a clinician-rated global assessment of a patient's improvement over time. Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse).

    Measured: Week 8

  2. Number of Participants With Response at Week 8

    Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint

    Measured: Week 8

  3. Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)

    CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decrease in value indicates improvement.

    Measured: Week 8

  4. Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores

    Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement

    Measured: Week 8

  5. Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)

    A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient's improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement.

    Measured: Week 8

  6. Summary of Safety

    Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation

    Measured: continuous throughout the study

  7. Change From Baseline in Body Weight

    Adjusted mean change (Week 8 - baseline) in body weight

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2006 (estimated)
  2. Study start1 Jun 2006
  3. Primary completion1 Apr 2008
  4. Study completion1 Apr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00332241
Sponsor's protocol ID
CN138-178
Status last verified
Apr 2026
First submitted
31 May 2006
Last updated
13 May 2026
Data monitoring committee
Yes

Publications

  • Owen R, Sikich L, Marcus RN, Corey-Lisle P, Manos G, McQuade RD, Carson WH, Findling RL. Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder. Pediatrics. 2009 Dec;124(6):1533-40. doi: 10.1542/peds.2008-3782.

    PubMed 19948625

  • Mankoski R, Stockton G, Manos G, Marler S, McQuade R, Forbes RA, Marcus R. Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):572-6. doi: 10.1089/cap.2012.0075.

    PubMed 24138011

  • Robb AS, Andersson C, Bellocchio EE, Manos G, Rojas-Fernandez C, Mathew S, Marcus R, Owen R, Mankoski R. Safety and tolerability of aripiprazole in the treatment of irritability associated with autistic disorder in pediatric subjects (6-17 years old):results from a pooled analysis of 2 studies. Prim Care Companion CNS Disord. 2011;13(1):PCC.10m01008. doi: 10.4088/PCC.10m01008gry.

    PubMed 21731831

  • Aman MG, Kasper W, Manos G, Mathew S, Marcus R, Owen R, Mankoski R. Line-item analysis of the Aberrant Behavior Checklist: results from two studies of aripiprazole in the treatment of irritability associated with autistic disorder. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):415-22. doi: 10.1089/cap.2009.0120.

    PubMed 20973712

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole in people with Autistic Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00332241, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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