NCT00027404

Study of Fluoxetine in Adults With Autistic Disorder

Fluoxetine vs Placebo in Adult Autistic Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (planned)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Autistic Disorder

Interventions

Type	Name	Description
DRUG	Fluoxetine

Timeline

• Start date: 2001-09-01
• Completion: 2005-08-01
• First posted: 2001-12-07
• Last updated: 2015-03-25

Locations

1 site across 1 country: United States