Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)
NCT ID: NCT00365859
Last Updated: 2013-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
330 participants
INTERVENTIONAL
2006-09-30
2009-06-30
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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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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De Novo
De novo participants (those who did not participate in protocol (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]) assigned to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
Aripiprazole
Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks
Rollover Placebo
Participants who completed participation in protocol (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]) on placebo treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
Aripiprazole
Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks
Rollover Aripiprazole
Participants who completed participation in protocol CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\] on aripiprazole treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
Aripiprazole
Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks
Interventions
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Aripiprazole
Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No significant protocol violations and sufficient medical justification to continue on open-label treatment with aripiprazole
* 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) or the patient meets the current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and has a history of behavioral problems that are currently being treated with psychotropic medication
* Mental age of at least 18 months
* Male or female 6 to 17 years of age, inclusive, at the time of enrollment
Exclusion Criteria
* Patients previously treated and not responding to aripiprazole treatment
* The patient is currently diagnosed with another disorder on the autism spectrum, including pervasive developmental disorder-not otherwise specified (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
Univ of Arizona
Tuscon, Arizona, United States
Clinical Innovations, Inc
Costa Mesa, California, United States
Peninsula Research Assoc
Rolling Hills Estate, California, United States
University Of California-Davis Health Science Center
Sacramento, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
Stanford University School Of Medicine
Stanford, California, United States
The Children's Hospital
Aurora, Colorado, United States
Offices of Gregory Marsella, MD, PA
Boca Raton, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
University of Florida
Gainesville, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Children's Developmental Center
Winter Park, Florida, United States
Child Neurology Associates, PC
Atlanta, Georgia, United States
Institute For Behavioral Medicine
Smyrna, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Kansas University Medical Center
Kansas City, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Massachusetts General Hospital
Cambridge, Massachusetts, United States
Cambridge Health Alliance
Cambridge, Massachusetts, United States
Ladders Clinic
Wellsley, Massachusetts, United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States
Children's Hospital Of Michigan
Detroit, Michigan, United States
Regions Hospital
Saint Paul, Minnesota, United States
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States
Munroe-Meyer Institute Diagnostic Center
Omaha, Nebraska, United States
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, United States
Children's Specialized Hospital
Toms River, New Jersey, 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
SUNY at Stony Brook - School of Medicine
Stony Brook, New York, United States
Mission Hospitals - Mission Children's Clinics
Asheville, North Carolina, United States
University of NC
Chapel Hill, North Carolina, United States
Duke Child and Family Study Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, 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
UT Medical Group, Department Of Psychiatry
Memphis, Tennessee, United States
Dallas Pediatric Neurology Associates
Dallas, Texas, United States
Bayou City Research, Ltd.
Houston, Texas, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
North San Antonio Healthcare Associates
San Antonio, Texas, United States
Children's National Medical Center
Fairfax, Virginia, United States
Neuroscience, Inc
Herndon, Virginia, United States
Monarch Research Associates
Norfolk, Virginia, United States
Virginia Treatment Center For Children
Richmond, Virginia, United States
Pacific Institute of Medical Sciences
Bothell, Washington, United States
Autism Spectrum Treatment and Research Center
Seattle, Washington, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.
Marcus RN, Owen R, Manos G, Mankoski R, Kamen L, McQuade RD, Carson WH, Findling RL. Safety and tolerability of aripiprazole for irritability in pediatric patients with autistic disorder: a 52-week, open-label, multicenter study. J Clin Psychiatry. 2011 Sep;72(9):1270-6. doi: 10.4088/JCP.09m05933. Epub 2011 Jul 26.
Marcus RN, Owen R, Manos G, Mankoski R, Kamen L, McQuade RD, Carson WH, Corey-Lisle PK, Aman MG. Aripiprazole in the treatment of irritability in pediatric patients (aged 6-17 years) with autistic disorder: results from a 52-week, open-label study. J Child Adolesc Psychopharmacol. 2011 Jun;21(3):229-36. doi: 10.1089/cap.2009.0121.
Related Links
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Investigator Inquiry form
Centers for Disease Control and Prevention (CDC) algorithm for BMI and body weight z-scores
Other Identifiers
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CN138-180
Identifier Type: -
Identifier Source: org_study_id