Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Emory University
ClinicalTrials.gov Identifier:
NCT00208741
First received: September 13, 2005
Last updated: November 8, 2013
Last verified: November 2013

September 13, 2005
November 8, 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 ClinicalTrials.gov 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00208741
0337-2002
Not Provided
Emory University
Emory University
Cephalon
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