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

Social Anxiety Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208741
• Other study ID #: 0337-2002
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: November 8, 2013
• Start date: June 2002
• Est. completion date: November 2003

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobic Disorders
• Social Anxiety Disorder

Intervention

Drug:
• Gabitril

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Hillside Hospital of the North Shore-Long Island Jewish Health System	Long Island	New York
United States	Columbia/New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Cephalon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liebowitz Social Anxiety Scale (LSAS)
Primary	Clinical Global Impression-Change (CGI-C)
Secondary	Hamilton Anxiety Scale (HAM-A)
Secondary	Social Phobia Inventory (SPIN)
Secondary	Pittsburgh Sleep Quality Index (PSQI)
Secondary	36-Item Short-Form Health Survey (SF-36)
Secondary	Clinical Global Impression-S (CGI-S).