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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double

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.

Interventions

  • Drug: Gabitril

Clinical Trial Outcome Measures

Primary Measures

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

Secondary 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Emory University
  • Collaborator
    • Cephalon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Philip T Ninan, MD, Principal Investigator, Emory University

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