Viewing Study NCT00027404



Ignite Creation Date: 2024-05-05 @ 11:24 AM
Last Modification Date: 2024-10-26 @ 9:06 AM
Study NCT ID: NCT00027404
Status: COMPLETED
Last Update Posted: 2015-03-25
First Post: 2001-12-05

Brief Title: Study of Fluoxetine in Adults With Autistic Disorder
Sponsor: Icahn School of Medicine at Mount Sinai
Organization: FDA Office of Orphan Products Development

Study Overview

Official Title: Fluoxetine vs Placebo in Adult Autistic Disorder
Status: COMPLETED
Status Verified Date: 2002-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
FD-R-002026-01 None None None