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

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder (SAD).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Cephalon
• Treatments: Tiagabine

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