Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00515320
Status:
COMPLETED
Last Update Posted:
2012-04-27
First Post:
2007-08-10
Brief Title:
Study of Fluoxetine in Autism
Sponsor:
Neuropharm
Organization:
Neuropharm
Study Overview
Official Title:
Study Of Fluoxetine In Autism A Randomised Double-Blind Placebo-Controlled Parallel-Group 14-Week Study To Investigate The Effect Of Fluoxetine Orally Dissolving Tablet ODT On Repetitive Behaviors In Childhood And Adolescent Autistic Disorder
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOFIA
Brief Summary:
The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets ODT on the repetitive behaviors core domain in children and adolescents with Autistic Disorder The study will also investigate the effect of fluoxetine on the improvement of symptoms and the effects on daily living of the patients family
Detailed Description:
None
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