Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
NCT ID: NCT00337571
Last Updated: 2013-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
218 participants
INTERVENTIONAL
2006-06-30
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A1
5 mg
Aripiprazole
Tablets, Oral, once daily, 8 weeks
A2
10 mg
Aripiprazole
Tablets, Oral, once daily, 8 weeks
A3
15 mg
Aripiprazole
Tablets, Oral, once daily, 8 weeks
B1
Placebo
Tablets, Oral, once daily, 8 weeks
Interventions
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Aripiprazole
Tablets, Oral, once daily, 8 weeks
Placebo
Tablets, Oral, once daily, 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
6 Years
17 Years
ALL
No
Sponsors
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Otsuka America Pharmaceutical
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of Alabama At Birmingham
Birmingham, Alabama, United States
Harmonex Neuroscience
Dothan, Alabama, United States
Southwest Autism Research And Resource Center
Phoenix, Arizona, United States
Clinical Innovations, Inc.
Huntington Beach, California, United States
University Of California-Davis Medical Center
Sacramento, California, United States
Stanford University School Of Medicine
Stanford, California, United States
The Children'S Hospital
Aurora, Colorado, United States
Marsella, Gregory
Boca Raton, Florida, United States
University Of Florida
Gainesville, Florida, United States
University Of South Florida
Tampa, Florida, United States
Institute For Behavioral Medicine
Smyrna, Georgia, United States
University Of Illinois At Chicago
Chicago, Illinois, United States
Cambridge Health Alliance
Medford, Massachusetts, United States
Ladders Clinic
Wellsley, Massachusetts, United States
Children'S Hospital Of Michigan
Detroit, Michigan, United States
Regions Hospital
Saint Paul, Minnesota, United States
Children'S Mercy Hospital
Kansas City, Missouri, United States
Munroe-Meyer Institute
Omaha, Nebraska, United States
North Shore - Long Island Jewish Health System
Bethpage, New York, United States
Seaver And New York Autism Center Of Excellence
New York, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Mission Hospitals
Asheville, North Carolina, United States
Duke Child And Family Study Center
Durham, North Carolina, United States
The Nisonger Center
Columbus, Ohio, United States
Cutting Edge Research
Oklahoma City, Oklahoma, United States
Western Psychiatric Institute And Clinic
Pittsburgh, Pennsylvania, United States
Dallas Pediatric Neurology Associates
Dallas, Texas, United States
Bayou City Research, Ltd.
Houston, Texas, United States
Children'S National Medical Center
Fairfax, Virginia, United States
Pacific Institute Of Medical Sciences
Bothell, Washington, United States
Children'S Hospital Of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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CN138-179
Identifier Type: -
Identifier Source: org_study_id