Randomized Study of Fluoxetine in Children and Adolescents With Autism

Study Overview
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Brief Summary
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OBJECTIVES: I. Evaluate the efficacy of fluoxetine on social and language deficits, global severity and compulsive dimensions of children and adolescents with autism. II. Assess the effectiveness of this treatment regimen on neurocognitive deficits in this patient population. III. Compare the baseline compulsive severity and treatment outcome in these patients.

Detailed Description
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PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study. All patients receive oral placebo daily during week 0. Patients are randomized to receive either oral fluoxetine or oral placebo daily on weeks 1-8. Patients then crossover to receive treatment on the other arm during weeks 12-20. Completion date provided represents the completion date of the grant per OOPD records

Conditions
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Autism

Intervention / Treatment
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* Drug: fluoxetine


Participation Criteria
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Eligibility Criteria
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PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Meets diagnostic criteria for autism --Prior/Concurrent Therapy-- Other: At least 3 months since prior electroconvulsive therapy At least 1 month since prior investigational drugs or treatment with any drug known to cause major organ toxicity At least 2 weeks since prior monoamine oxidase inhibitors At least 6 weeks since prior long acting phenothiazines At least 1 week since prior other psychotropic drugs No prior fluoxetine of 20 mg/day for 6 weeks At least 6 weeks since prior fluoxetine No concurrent use of terfenadine (Seldane) or astemizole (Hismanal) No concurrent electroconvulsive therapy or other psychotropic drugs (unless otherwise permitted) Prior participation in another serotonin reuptake inhibitor trial allowed --Patient Characteristics-- Hematopoietic: No significant hematopoietic disease Hepatic: No prior or concurrent liver disease Renal: No prior or concurrent kidney disease Cardiovascular: No significant cardiovascular disease No abnormal EKG Neurological: No prior seizure disorder or high risk development of seizures No prior cerebrovascular disease No prior brain trauma Other: Not pregnant or nursing Negative pregnancy test No unstable major medical illness or systemic disease No moderate or severe mental retardation and motor deficits (IQ less than 50) No family history of bipolar disorder No prior or concurrent other mental disorders (e.g., schizophrenia, schizoaffective, organic, or bipolar disorders) No significant autoaggressive behavior or serious suicidal risk No prior or concurrent gastrointestinal conditions No unstable endocrine disease (e.g., hypo or hyperthyroidism) No prior or concurrent malignancy Must be able to tolerate tapering of psychoactive medication No history of hypersensitivity or severe side effects to fluoxetine or other serotonin reuptake inhibitors No history of severe personality disorder or noncompliance

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluoxetine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autism, neurologic and psychiatric disorders, rare disease