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

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Emory University
ClinicalTrials.gov Identifier:
NCT00208741
First received: September 13, 2005
Last updated: November 8, 2013
Last verified: November 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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
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
Cephalon
Investigators
Principal Investigator: Philip T Ninan, MD Emory University
  More Information

No publications provided

Responsible Party: Emory University
ClinicalTrials.gov Identifier: NCT00208741     History of Changes
Other Study ID Numbers: 0337-2002
Study First Received: September 13, 2005
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Social Anxiety Disorder
Mental Health

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Tiagabine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
GABA Agonists
GABA Agents

ClinicalTrials.gov processed this record on August 26, 2014