Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-29 @ 9:24 AM
Study NCT ID:
NCT00027404
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2001-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Fluoxetine in Adults With Autistic Disorder
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
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
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| FD-R-002026-01 | None | None | View |