Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
NCT ID: NCT00332241
Last Updated: 2013-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
98 participants
INTERVENTIONAL
2006-06-30
2008-04-30
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
Active Abilify
Aripiprazole
Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks
A2
Placebo
Tablets, Oral, once daily, 8 weeks
Interventions
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Aripiprazole
Tablets, Oral, 5, 10, or 15 mg, 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 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 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.
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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Marsella, Gregory
Boca Raton, Florida, United States
Child Neurology Associates, Pc
Atlanta, Georgia, United States
University Of Louisville
Louisville, Kentucky, United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States
Center For Psychiatry And Behavioral Medicine
Las Vegas, Nevada, United States
Suny - Stony Brook School Of Medicine
Stony Brook, New York, United States
Univ Of Nc
Chapel Hill, North Carolina, United States
Ut Medical Group
Memphis, Tennessee, United States
Red Oak Psychiatry Associates, Pa
Houston, Texas, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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CN138-178
Identifier Type: -
Identifier Source: org_study_id