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

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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00208741

Enrollment

Registered

2005-09-21

Start date

2002-06-30

Completion date

2003-11-30

Last updated

2013-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Anxiety Disorder

Keywords

Social Anxiety Disorder, Mental Health

Brief summary

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

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

DRUGGabitril

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Liebowitz Social Anxiety Scale (LSAS)	—
Clinical Global Impression-Change (CGI-C)	—

Secondary

Measure	Time frame
Pittsburgh Sleep Quality Index (PSQI)	—
Hamilton Anxiety Scale (HAM-A)	—
Clinical Global Impression-S (CGI-S).	—
36-Item Short-Form Health Survey (SF-36)	—
Social Phobia Inventory (SPIN)	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026