Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Behavioral Symptoms, Autistic Disorder

In brief

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).

Key facts

Study ID

NCT00337571

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

218

Starts

2006-06-01

Expected to finish

2008-06-01

Last updated by the study team

2026-05-13

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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