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

Condition(s) targeted: Social Anxiety Disorder

Intervention: Gabitril (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Philip T Ninan, MD, Principal Investigator, Affiliation: Emory University

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

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Liebowitz Social Anxiety Scale (LSAS)

Clinical Global Impression-Change (CGI-C)

Secondary outcome:

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).

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Emory University School of Medicine, Atlanta, Georgia 30329, United States

Columbia/New York State Psychiatric Institute, New York, New York 10032, United States

Hillside Hospital of the North Shore-Long Island Jewish Health System, Long Island, New York 10032, United States

Starting date: June 2002
Ending date: November 2003
Last updated: September 13, 2005