Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder - Full Text View

Sponsors and Collaborators:	Emory University Cephalon
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00208741

Purpose

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

Condition	Intervention	Phase
Social Anxiety Disorder	Drug: Gabitril	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Tiagabine Tiagabine hydrochloride

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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).

Estimated Enrollment:	50
Study Start Date:	June 2002
Estimated Study Completion Date:	November 2003

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208741

Locations

United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30329
United States, New York
Columbia/New York State Psychiatric Institute
New York, New York, United States, 10032
Hillside Hospital of the North Shore-Long Island Jewish Health System
Long Island, New York, United States, 10032

Sponsors and Collaborators

Emory University

Cephalon

Investigators

Principal Investigator:

Philip T Ninan, MD

Emory University

More Information

No publications provided

Study ID Numbers:	337-2002
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00208741 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Emory University:

Social Anxiety Disorder
Mental Health

Study placed in the following topic categories:

Neurotransmitter Agents
Anxiety Disorders
Tiagabine
Mental Disorders

GABA Agonists
Phobic Disorders
Anticonvulsants

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Phobic Disorders
Pharmacologic Actions
Pathologic Processes

Anxiety Disorders
Mental Disorders
Tiagabine
GABA Agonists
Therapeutic Uses
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on August 30, 2009