Randomized Study of Fluoxetine in Children and Adolescents With Autism

Not Applicable

Completed

• Conditions: Autism

• Registration Number: NCT00004486
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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

Study Timeline

• Study Start: 1998-09
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Status Verified: 2000-12
• Study Completion: 2002-12
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Trial Locations

Locations (3)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

New York University Medical Center; 🇺🇸 New York, New York, United States