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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208741
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 11, 2013
Information provided by (Responsible Party):
Emory University

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

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: Gabitril Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : June 2002
Study Completion Date : November 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Primary Outcome Measures :
  1. Liebowitz Social Anxiety Scale (LSAS)
  2. Clinical Global Impression-Change (CGI-C)

Secondary Outcome Measures :
  1. Hamilton Anxiety Scale (HAM-A)
  2. Social Phobia Inventory (SPIN)
  3. Pittsburgh Sleep Quality Index (PSQI)
  4. 36-Item Short-Form Health Survey (SF-36)
  5. Clinical Global Impression-S (CGI-S).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00208741

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United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30329
United States, New York
Hillside Hospital of the North Shore-Long Island Jewish Health System
Long Island, New York, United States, 10032
Columbia/New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Emory University
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Principal Investigator: Philip T Ninan, MD Emory University
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Responsible Party: Emory University Identifier: NCT00208741    
Other Study ID Numbers: 0337-2002
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: November 2013
Keywords provided by Emory University:
Social Anxiety Disorder
Mental Health
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders
GABA Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs