Behavioral SymptomsPhase 3NCT00337571

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

A Phase 3 study testing Aripiprazole in people with Behavioral Symptoms and Autistic Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 31 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 with placebo (fixed dose) 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: Behavioral Symptoms, 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: 218 participants
Where: 31 sitesUnited States
Study dates: 1 Jun 2006to 1 Jun 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 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

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, 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

Trial locations and contacts

31 sites in 1 country.

City, postcode or hospital

31 sites in 1 country

United States31 sites

Mission Hospitals
Asheville, North Carolina, 28801
The Children'S Hospital
Aurora, Colorado, 80045
North Shore - Long Island Jewish Health System
Bethpage, New York, 11714
University Of Alabama At Birmingham
Birmingham, Alabama, 35294
Marsella, Gregory
Boca Raton, Florida, 33432
Pacific Institute Of Medical Sciences
Bothell, Washington, 98011
University Of Illinois At Chicago
Chicago, Illinois, 60606
The Nisonger Center
Columbus, Ohio, 43210
Dallas Pediatric Neurology Associates
Dallas, Texas, 75230
Children'S Hospital Of Michigan
Detroit, Michigan, 48201
Harmonex Neuroscience
Dothan, Alabama, 36303
Duke Child And Family Study Center
Durham, North Carolina, 27710
Children'S National Medical Center
Fairfax, Virginia, 22031
University Of Florida
Gainesville, Florida, 32611
Bayou City Research, Ltd.
Houston, Texas, 77007
Clinical Innovations, Inc.
Huntington Beach, California, 92647
Children'S Mercy Hospital
Kansas City, Missouri, 64108
Cambridge Health Alliance
Medford, Massachusetts, 02139
Children'S Hospital Of Wisconsin
Milwaukee, Wisconsin, 53201
Seaver And New York Autism Center Of Excellence
New York, New York, 10029
Cutting Edge Research
Oklahoma City, Oklahoma, 73116
Munroe-Meyer Institute
Omaha, Nebraska, 68198
Southwest Autism Research And Resource Center
Phoenix, Arizona, 85006
Western Psychiatric Institute And Clinic
Pittsburgh, Pennsylvania, 15203
University Of California-Davis Medical Center
Sacramento, California, 95817
Regions Hospital
Saint Paul, Minnesota, 55101
Institute For Behavioral Medicine
Smyrna, Georgia, 30080
Stanford University School Of Medicine
Stanford, California, 94305
Richmond Behavioral Associates
Staten Island, New York, 10312
University Of South Florida
Tampa, Florida, 33613
Ladders Clinic
Wellesley, Massachusetts, 02481

Other trials in United States

About this study

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

Conditions: Behavioral Symptoms, Autistic Disorder
Being tested: Aripiprazole, Placebo
Keywords: Serious behavioral problems in children and adolescents with AD
Medical subject headings: Behavioral Symptoms, Autistic Disorder

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, once daily, 8 weeks
PlaceboDrug
Tablets, Oral, once daily, 8 weeks

Study groups in NCT00337571
Study group	Role	What they receive
A1	Experimental	5 mg Receives: Drug: Aripiprazole
A2	Experimental	10 mg Receives: Drug: Aripiprazole
A3	Experimental	15 mg Receives: Drug: Aripiprazole
B1	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

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)

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
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
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 decreased in value indicates improvement.
Measured: Week 8
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
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
Summary of Safety
Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation
Measured: continuously throughout the study
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 Jun 20061 Jun 2008

First posted16 Jun 2006 (estimated)
Study start1 Jun 2006
Primary completion1 Jun 2008
Study completion1 Jun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Behavioral SymptomsStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 218 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00337571
Sponsor's protocol ID: CN138-179
Status last verified: Apr 2026
First submitted: 13 Jun 2006
Last updated: 13 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Marcus RN, Owen R, Kamen L, Manos G, McQuade RD, Carson WH, Aman MG. A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. J Am Acad Child Adolesc Psychiatry. 2009 Nov;48(11):1110-1119. doi: 10.1097/CHI.0b013e3181b76658.
PubMed 19797985
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study With Three Fixed Doses of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
ClinicalTrials.gov ID: NCT00337571
Acronym / sponsor ID: CN138-179
Conditions: Behavioral Symptoms, Autistic Disorder
Keywords: Serious behavioral problems in children and adolescents with AD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 218 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
Collaborators: Otsuka America Pharmaceutical
Study start: 1 Jun 2006 (actual)
Primary completion: 1 Jun 2008 (actual)
Study completion: 1 Jun 2008 (actual)
First posted: 16 Jun 2006 (estimated)
Results: Posted 23 Jul 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
A1	Experimental	Drug: Aripiprazole5 mg
A2	Experimental	Drug: Aripiprazole10 mg
A3	Experimental	Drug: Aripiprazole15 mg
B1	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AripiprazoleAlso: AbilifyTablets, Oral, once daily, 8 weeks	Drug	A1, A2, A3
PlaceboTablets, Oral, once daily, 8 weeks	Drug	B1

Primary outcome

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

7 secondary outcomes

Mean Clinical Global Impressions Improvement Scale (CGI-I) Score
Time frame: Week 8
Number of Participants With Response at Week 8
Time frame: Week 8
Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)
Time frame: Week 8
Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores
Time frame: Week 8
Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)
Time frame: Week 8
Summary of Safety
Time frame: continuously throughout the study
Change From Baseline in Body Weight
Time frame: Week 8

Results and safety

Results posted to the registry on 23 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	52	38
Aripiprazole 5 mg	53	44
Aripiprazole 10 mg	59	49
Aripiprazole 15 mg	54	47

Primary outcome: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score

Time frame: Week 8. Mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 49	Aripiprazole 5 mg n = 52	Aripiprazole 10 mg n = 59	Aripiprazole 15 mg n = 53
Value	-8.4 (1.39)	-12.4 (1.36)	-13.2 (1.25)	-14.4 (1.31)

Population analysed: Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aripiprazole 10 mg	1 of 59 (1.7%)	51 of 59 (86.4%)	Not reported
Aripiprazole 15 mg	0 of 54 (0%)	42 of 54 (77.8%)	Not reported
Aripiprazole 5 mg	1 of 52 (1.9%)	37 of 52 (71.2%)	Not reported
Placebo	0 of 51 (0%)	31 of 51 (60.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19797985Marcus RN, Owen R, Kamen L, Manos G, McQuade RD, Carson WH, Aman MG. A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. J Am Acad Child Adolesc Psychiatry. 2009 Nov;48(11):1110-1119. doi: 10.1097/CHI.0b013e3181b76658.
Derived from this study: PubMed 24138011Mankoski 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.
Derived from this study: PubMed 21731831Robb 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.
Otsuka Clinical Trial WebsiteLink provided by the sponsor.
Otsuka Clinical Trial TransparencyLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

31 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole in people with Behavioral Symptoms and Autistic Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 31 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 31 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 NCT00337571, which also lists 3 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.