CClinicalTrials.gg
CompletedNCT00208741Updated Nov 11, 2013

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

A Phase 4 interventional study of Gabitril in Social Anxiety Disorder, sponsored by Emory University. Completed at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-11-11.

Sponsored by Emory University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Social Anxiety Disorder

Keywords

  • Social Anxiety Disorder
  • Mental Health
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 50 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
50 participants

Interventions

  • DrugGabitril
06

What researchers measure

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).

07

Study locations

3 sites
  • Emory University School of Medicine
    Atlanta, Georgia 30329, United States
  • Hillside Hospital of the North Shore-Long Island Jewish Health System
    Long Island, New York 10032, United States
  • Columbia/New York State Psychiatric Institute
    New York, New York 10032, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00208741
Lead sponsor
Emory University
Collaborators
Cephalon
Responsible party
Sponsor
First posted
Sep 21, 2005
Start date
Jun 2002
Completion
Nov 2003
Last update
Nov 11, 2013

Study contacts

Philip T Ninan, MD
principal investigator · Emory University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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