Study of Fluoxetine in Adults With Autistic Disorder

Not Applicable

Completed

• Conditions: Autistic Disorder

• Registration Number: NCT00027404
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

This is a study to determine the effect of fluoxetine in the treatment of adult autism and on functional ability and behavior associated with autism. Evidence suggests abnormal serotonin function in autism. Fluoxetine is a selective inhibitor of the serotonin transporter.

Detailed Description

Eligible patients will undergo comprehensive evaluation. Informants familiar with the patient will also provide information. Patients will be randomized to receive treatment or placebo. During the 12-week treatment there will be weekly monitoring for the first 4 weeks and biweekly monitoring for the next 8 weeks. The drug dosage will be increased each week as tolerated by the patient. Serum levels of fluoxetine and norfluoxetine will be documented at Week 12.

Completion date provided represents the completion date of the grant per OOPD records

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2001-12-05
• Study First Submitted QC: 2001-12-06
• Study First Posted: 2001-12-07
• Status Verified: 2002-11
• Study Completion: 2005-08
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

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