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

Phase 4

Completed

• Conditions: Social Anxiety Disorder

• Registration Number: NCT00208741
• Lead Sponsor: Emory University

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 Timeline

• Study Start: 2002-06
• Study Completion: 2003-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-08
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression-Change (CGI-C)
Liebowitz Social Anxiety Scale (LSAS)

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (3)

Columbia/New York State Psychiatric Institute; 🇺🇸 New York, New York, United States

Hillside Hospital of the North Shore-Long Island Jewish Health System; 🇺🇸 Long Island, New York, United States

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States