Clinical Trial: Study of Fluoxetine in Adults With Autistic Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Fluoxetine vs Placebo in Adult Autistic Disorder

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 Summary:

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

Sponsor: Icahn School of Medicine at Mount Sinai

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: FDA Office of Orphan Products Development

Dates:
Date Received: December 5, 2001
Date Started: September 2001
Date Completion: August 2005
Last Updated: March 24, 2015
Last Verified: November 2002