Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208741
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 11, 2013
Information provided by (Responsible Party):
Emory University

September 13, 2005
September 21, 2005
November 11, 2013
June 2002
Not Provided
  • Liebowitz Social Anxiety Scale (LSAS)
  • Clinical Global Impression-Change (CGI-C)
Same as current
Complete list of historical versions of study NCT00208741 on Archive Site
  • Hamilton Anxiety Scale (HAM-A)
  • Social Phobia Inventory (SPIN)
  • Pittsburgh Sleep Quality Index (PSQI)
  • 36-Item Short-Form Health Survey (SF-36)
  • Clinical Global Impression-S (CGI-S).
Same as current
Not Provided
Not Provided
Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder
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)
The main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder (SAD).
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.
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Social Anxiety Disorder
Drug: Gabitril
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2003
Not Provided

Inclusion Criteria:

  • Primary diagnosis of SAD
  • CGI (S) ≥ 4 at screen
  • LSAS ≥ 50 at baseline
  • Covi Anxiety Scale score greater than the Raskin depression Scale total score at screen

Exclusion Criteria:

  • Non-responsive to adequate trials of two or more treatment medications, if previously treated for SAD.
  • HAM-D ≥15 or a score of >2 on Item 1 at baseline
  • Serious or unstable medical condition
  • Alcohol or substance use disorder within 6 months prior to study
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Emory University
Emory University
Principal Investigator: Philip T Ninan, MD Emory University
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP