Status:
COMPLETED
Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder
Lead Sponsor:
Emory University
Collaborating Sponsors:
Cephalon
Conditions:
Social Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
November 1 2003
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00208741
Start Date
June 1 2002
End Date
November 1 2003
Last Update
November 11 2013
Active Locations (3)
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1
Emory University School of Medicine
Atlanta, Georgia, United States, 30329
2
Hillside Hospital of the North Shore-Long Island Jewish Health System
Long Island City, New York, United States, 10032
3
Columbia/New York State Psychiatric Institute
New York, New York, United States, 10032