Randomized Study of Fluoxetine in Children and Adolescents With Autism
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 45
- Locations
- 3
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Detailed 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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified