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Randomized Study of Fluoxetine in Children and Adolescents With Autism

Autism Clinical Trial

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00004486
Study type Interventional
Source FDA Office of Orphan Products Development
Contact
Status Completed
Phase N/A
Start date September 1998
Completion date December 2002
View Details
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