Study of Fluoxetine in Autism
- Registration Number
- NCT00515320
- Lead Sponsor
- Neuropharm
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
- Meets DSM-IV criteria for autistic disorder, .
- CYBOCS-PDD score of at least 10 at screening.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Fluoxetine Fluoxetine -
- Primary Outcome Measures
Name Time Method The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score. Throughout the study
- Secondary Outcome Measures
Name Time Method The time and dose related course of therapeutic effects Throughout the study The inter-relationship between these effects in the context of global clinical changes. Throughout the study The indirect effects on patient caregivers of the dose regime in these subjects compared to placebo during treatment. Throughout the study Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests. Throughout the study
Trial Locations
- Locations (17)
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, New Jersey, United States
Scroll for more (7 remaining)Southwest Autism Research and Resource Centre🇺🇸Phoenix, Arizona, United States