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Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
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).
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)
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
218
Start Date
2006-06-01
Completion Date
2008-06-01
Last Updated
2026-05-13
Healthy Volunteers
No
Conditions
Interventions
Aripiprazole
Tablets, Oral, once daily, 8 weeks
Placebo
Tablets, Oral, once daily, 8 weeks
Locations (31)
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
Wellesley, 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