Study of Fluoxetine in Autism

Completed · Phase 3 · Has a placebo group

Conditions studied: Autistic Disorder

In brief

The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets (ODT) on the repetitive behaviors core domain in children and adolescents with Autistic Disorder. The study will also investigate the effect of fluoxetine on the improvement of symptoms and the effects on daily living of the patient's family.

Key facts

Study ID

NCT00515320

Run by

Neuropharm

People needed

158

Starts

2007-08-01

Expected to finish

2009-01-01

Last updated by the study team

2012-04-27

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets DSM-IV criteria for autistic disorder, .
• CYBOCS-PDD score of at least 10 at screening.

You may not qualify if…

• Diagnosis of Asperger Syndrome or Pervasive Developmental Disorder Not Otherwise Specified, Rett Syndrome, Childhood Disintegrative Disorder.
• Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment.
• Patients who are currently taking fluoxetine or who have previously taken it are not eligible for the study.
• Other protocol-defined Inclusion/Exclusion criteria may apply.

Where it is running

• Southwest Autism Research and Resource Centre — Phoenix, Arizona, United States
• University of California Davis — Sacramento, California, United States
• University of Florida, Department of Psychiatry — Gainesville, Florida, United States
• Institute for Behavioral Medicine — Smyrna, Georgia, United States
• University of Illinois — Chicago, Illinois, United States
• AMR-Baber Research Inc. — Naperville, Illinois, United States
• Harvard Medical School — Medford, Massachusetts, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Center for Psychiatry and Behavioral Medicine — Las Vegas, Nevada, United States
• CRCNJ — Voorhees Township, New Jersey, United States
• Long Island Jewish Hospital — Bethpage, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic — Pittsburgh, Pennsylvania, United States
• Red Oak Psychiatry Associates — Houston, Texas, United States
• Seattle Children's Hosptial University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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