NCT00208741

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2002

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

November 11, 2013

Status Verified

November 1, 2013

First QC Date

September 13, 2005

Last Update Submit

November 8, 2013

Conditions

Social Anxiety Disorder

Keywords

Social Anxiety DisorderMental Health

Outcome Measures

Primary Outcomes (2)

  • Liebowitz Social Anxiety Scale (LSAS)

  • Clinical Global Impression-Change (CGI-C)

Secondary Outcomes (5)

  • 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).

Interventions

GabitrilDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Emory University School of Medicine

Atlanta, Georgia, 30329, United States

Location

Hillside Hospital of the North Shore-Long Island Jewish Health System

Long Island City, New York, 10032, United States

Location

Columbia/New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Phobia, SocialPsychological Well-Being

Interventions

Tiagabine

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Nipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Philip T Ninan, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

June 1, 2002

Study Completion

November 1, 2003

Last Updated

November 11, 2013

Record last verified: 2013-11

Locations

US(3)