Status:
WITHDRAWN
Fluoxetine Essay in Children With Autism
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Autism
Eligibility:
All Genders
5-12 years
Phase:
PHASE2
Brief Summary
This study is a comparative, double blind, placebo controlled trial of 6-months duration designed to evaluate 1) the effects of fluoxetine in 5 to 12 years old autistic children, 2) the effects of flu...
Detailed Description
Autism is a severe neurodevelopmental disorder characterized by impaired social interaction and communication, and by a markedly restricted repertoire of activities and interests. The population preva...
Eligibility Criteria
Inclusion
- Male and female subjects with diagnosis of Pervasive developmental disorder (PDD) meeting all criteria listed bellow will be included in the study:
- age 5 to 12 years, outpatients.
- presenting with a primary diagnosis of autism according to DSM- IV-R.
- Autism will be diagnosed with Autism Diagnostic Interview (ADI)
- with a score of 30 or above on the Children Autistic Rating Scale (CARS, SCHOPLER et al., 1980).
- Written informed consent obtained from each patient's parents or legal guardian.
Exclusion
- Subjects presenting with any of the following will not be included in the study:
- Participation in any other studies involving investigational or marketed products within 6 months prior to entry in the study.
- Treatment given for autism within the previous 1 month
- Organic mental disorder or organic brain syndrome (including epilepsy)
- Severe mental retardation (IQ \< 45).
- Specific systemic diseases, including history of significant hematological, endocrine, cardiovascular, renal, gastrointestinal or neurological disease (including more than one episode of childhood febrile convulsion).
- Medical contra-indication to treatment with any antidepressant and specially sertraline
- Previous history of intolerance or hypersensitivity to fluoxetine or to drugs with similar chemical structures
- Currant use of concomitant anticoagulant therapy
- Previous participation in any other clinical trial with the study drug
- Require concomitant therapy with any psychotropic drug or with any drug with a psychotropic component
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00873834
Start Date
September 1 2009
End Date
November 1 2011
Last Update
January 10 2012
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