Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208741
Status:
COMPLETED
Last Update Posted:
2013-11-11
First Post:
2005-09-13
Brief Title:
Study To Evaluate The Effects Of Gabitril In Patients With Social Anxiety Disorder
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A 12-Week Open-Label Study Followed By A 24-Week Double-Blind Discontinuation Exploratory Study To Evaluate The Effects Of Gabitril Tiagabine Hydrochloride In Patients With Social Anxiety Disorder SAD
Status:
COMPLETED
Status Verified Date:
2013-11
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:
The main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder SAD
Detailed Description:
This study is being conducted at two sites in the United States Approximately 50 patients who are between the ages of 18 and 65 years old will be enrolled at Emory This study consists of two parts The first part consists of 12 weeks of open-label treatment with Gabitril If the study doctor determines that the patients condition has improved and they have completed the initial 12 weeks of treatment they may be eligible for the second part of the study This part is a 24-week double-blind treatment period with either Gabitril or placebo inactive medication There will also be a follow-up visit about 1 to 3 weeks after they have completed taking the study medication Altogether study participation is expected to last approximately 37 weeks
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