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

Completed · Phase 3 · Has a placebo group

Conditions studied: Autistic Disorder

In brief

This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).

Key facts

Study ID

NCT00332241

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

98

Starts

2006-06-01

Expected to finish

2008-04-01

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 for Mental Disorders-Fourth Edition (DSM-IV) diagnostic criteria for AD and demonstrates serious behavioral problems. Diagnosis confirmed by Autism Diagnostic Interview- Revised (ADI-R)
• 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

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, 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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