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Completed

NCT Number: NCT00208741

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

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

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Behavior Mental Disorders Personal Satisfaction Phobia, Social Phobic Disorders Psychological Well-Being

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabitril

Drug

Primary outcomes

  1. Liebowitz Social Anxiety Scale (LSAS)

  2. Clinical Global Impression-Change (CGI-C)

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Cephalon

Registry information

Official study 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)

Important dates

Study start
2002
Study completion
2003
First posted
Sep 21, 2005
Registry last updated
Nov 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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