Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
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)
1 other identifier
interventional
218
1 country
31
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2006
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 13, 2006
CompletedFirst Posted
Study publicly available on registry
June 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
July 23, 2009
CompletedMay 13, 2026
April 1, 2026
2 years
June 13, 2006
June 3, 2009
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Week 8
Secondary Outcomes (7)
Mean Clinical Global Impressions Improvement Scale (CGI-I) Score
Week 8
Number of Participants With Response at Week 8
Week 8
Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)
Week 8
Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores
Week 8
Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)
Week 8
- +2 more secondary outcomes
Study Arms (4)
A1
EXPERIMENTAL5 mg
A2
EXPERIMENTAL10 mg
A3
EXPERIMENTAL15 mg
B1
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
University Of Alabama At Birmingham
Birmingham, Alabama, 35294, United States
Harmonex Neuroscience
Dothan, Alabama, 36303, United States
Southwest Autism Research And Resource Center
Phoenix, Arizona, 85006, United States
Clinical Innovations, Inc.
Huntington Beach, California, 92647, United States
University Of California-Davis Medical Center
Sacramento, California, 95817, United States
Stanford University School Of Medicine
Stanford, California, 94305, United States
The Children'S Hospital
Aurora, Colorado, 80045, United States
Marsella, Gregory
Boca Raton, Florida, 33432, United States
University Of Florida
Gainesville, Florida, 32611, United States
University Of South Florida
Tampa, Florida, 33613, United States
Institute For Behavioral Medicine
Smyrna, Georgia, 30080, United States
University Of Illinois At Chicago
Chicago, Illinois, 60606, United States
Cambridge Health Alliance
Medford, Massachusetts, 02139, United States
Ladders Clinic
Wellesley, Massachusetts, 02481, United States
Children'S Hospital Of Michigan
Detroit, Michigan, 48201, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Children'S Mercy Hospital
Kansas City, Missouri, 64108, United States
Munroe-Meyer Institute
Omaha, Nebraska, 68198, United States
North Shore - Long Island Jewish Health System
Bethpage, New York, 11714, United States
Seaver And New York Autism Center Of Excellence
New York, New York, 10029, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Mission Hospitals
Asheville, North Carolina, 28801, United States
Duke Child And Family Study Center
Durham, North Carolina, 27710, United States
The Nisonger Center
Columbus, Ohio, 43210, United States
Cutting Edge Research
Oklahoma City, Oklahoma, 73116, United States
Western Psychiatric Institute And Clinic
Pittsburgh, Pennsylvania, 15203, United States
Dallas Pediatric Neurology Associates
Dallas, Texas, 75230, United States
Bayou City Research, Ltd.
Houston, Texas, 77007, United States
Children'S National Medical Center
Fairfax, Virginia, 22031, United States
Pacific Institute Of Medical Sciences
Bothell, Washington, 98011, United States
Children'S Hospital Of Wisconsin
Milwaukee, Wisconsin, 53201, United States
Related Publications (3)
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.
PMID: 19797985BACKGROUNDMankoski 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.
PMID: 24138011DERIVEDRobb 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.
PMID: 21731831DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Transparency
- Organization
- Otsuka
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2006
First Posted
June 16, 2006
Study Start
June 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
May 13, 2026
Results First Posted
July 23, 2009
Record last verified: 2026-04