Fluoxetine vs Placebo in Adult Autistic Disorder

Icahn School of Medicine at Mount Sinai1 site in 1 country48 target enrollmentSeptember 2001

ConditionsAutistic Disorder

DrugsFluoxetine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Autistic Disorder
Sponsor: Icahn School of Medicine at Mount Sinai
Enrollment: 48
Locations: 1
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 2001

End Date

August 2005

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel