Back to resultsStudy To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder
Primary Purpose
Social Anxiety Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gabitril
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Social Anxiety Disorder, Mental Health
Eligibility Criteria
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
Sites / Locations
- Emory University School of Medicine
- Hillside Hospital of the North Shore-Long Island Jewish Health System
- Columbia/New York State Psychiatric Institute
Outcomes
Primary Outcome Measures
Liebowitz Social Anxiety Scale (LSAS)
Clinical Global Impression-Change (CGI-C)
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT00208741
First Posted
September 13, 2005
Last Updated
November 8, 2013
Sponsor
Emory University
Collaborators
Cephalon
1. Study Identification
Unique Protocol Identification Number
NCT00208741
Brief Title
Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2003 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emory University
Collaborators
Cephalon
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
Social Anxiety Disorder, Mental Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gabitril
Primary Outcome Measure Information:
Title
Liebowitz Social Anxiety Scale (LSAS)
Title
Clinical Global Impression-Change (CGI-C)
Secondary Outcome Measure Information:
Title
Hamilton Anxiety Scale (HAM-A)
Title
Social Phobia Inventory (SPIN)
Title
Pittsburgh Sleep Quality Index (PSQI)
Title
36-Item Short-Form Health Survey (SF-36)
Title
Clinical Global Impression-S (CGI-S).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip T Ninan, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Hillside Hospital of the North Shore-Long Island Jewish Health System
City
Long Island
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Columbia/New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder
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