Study of Fluoxetine in Adults With Autistic Disorder

Autistic Disorder Clinical Trial

Official title: Fluoxetine vs Placebo in Adult Autistic Disorder

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder

• NCT number: NCT00027404
• Study type: Interventional
• Source: FDA Office of Orphan Products Development
• Status: Completed
• Phase: N/A
• Start date: September 2001
• Completion date: August 2005