Fluoxetine Essay in Children With Autism

• Status: Withdrawn
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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 fluoxetine on serotoninergic parameters, 3) cerebral metabolic changes (rCBF measurements with PET) induced by the treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Fluoxetine; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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