Study To Evaluate The Effects Of Gabitrilâ¢ In Patients With Social Anxiety Disorder
Information source: Emory University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Social Anxiety Disorder
Intervention: Gabitril (Drug)
Phase: Phase 4
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
Liebowitz Social Anxiety Scale (LSAS)
Clinical Global Impression-Change (CGI-C)
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).
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.
- Primary diagnosis of SAD
- CGI (S) â¥ 4 at screen
- LSAS â¥ 50 at baseline
- Covi Anxiety Scale score greater than the Raskin depression Scale total score at
- Non-responsive to adequate trials of two or more treatment medications, if previously
treated for SAD.
- HAM-D â¥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
Locations and Contacts
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