Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183339
Status:
COMPLETED
Last Update Posted:
2014-03-26
First Post:
2005-09-06
Brief Title:
Early Intervention With Fluoxetine in Autism
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
A Randomized Placebo-controlled Trial of Fluoxetine in Preschool Children
Status:
COMPLETED
Status Verified Date:
2014-02
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:
None
Brief Summary:
This study is a pilot study to evaluate the feasibility and safety of conducting a year long double-blind placebo-controlled trial of fluoxetine in pre-school children to enhance developmental processes in core areas impacted by autism
Detailed Description:
Autism a brain disorder that affects a small percentage of Americans often results in a lifetime of impaired thinking feeling and social functioning The disorder generally becomes apparent in children by the age of 3 Autism typically affects a persons ability to communicate form relationships with others and respond appropriately to the external world Some people with autism can function at a relatively high level with speech and intelligence intact Others have serious cognitive impairments and language delays and some never speak This study will assess the safety and effectiveness of treating autistic children with fluoxetine to enhance developmental processes in core areas impacted by autism
Each participant was randomly assigned to treatment with double-blinded placebo or fluoxetine for 12 months After initial screening and randomization participants were assessed every two weeks for approximately the first 3 months or until the dose of medication is stabilized After this initial period they were assessed on a monthly basis Dosing was flexible as determined by the adverse and beneficial responses to treatment although there was a suggested titration schedule
Each participant was randomly assigned to treatment with double-blinded placebo or fluoxetine for 12 months After initial screening and randomization participants were assessed every two weeks for approximately the first 3 months or until the dose of medication is stabilized After this initial period they were assessed on a monthly basis Dosing was flexible as determined by the adverse and beneficial responses to treatment although there was a suggested titration schedule
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 |
|---|---|---|---|
| U54MH066418 | NIH | None | httpsreporternihgovquickSearchU54MH066418 |