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

Completed · Phase 3 · Has a placebo group

Conditions studied: Autistic Disorder, Behavioral Symptoms

In brief

This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).

Key facts

Study ID

NCT00365859

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

330

Starts

2006-09-01

Expected to finish

2009-06-01

Last updated by the study team

2026-08-04

Who can join

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

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 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

Where it is running

• Harmonex Neuroscience — Dothan, Alabama, United States
• Southwest Autism Research and Resource Center — Phoenix, Arizona, United States
• Univ of Arizona — Tucson, Arizona, United States
• Clinical Innovations, Inc — Costa Mesa, California, United States
• Peninsula Research Assoc — Rolling Hills Estates, 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 — Wellesley, Massachusetts, United States
• Neurobehavioral Medicine Group — Bloomfield Hills, Michigan, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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