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

Phase 4CompletedNCT00208741

Emory University50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Social Anxiety Disorder

Interventions

GabitrilDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

Emory University School of Medicine

Atlanta, Georgia, United States

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

Long Island City, New York, United States

Columbia/New York State Psychiatric Institute

New York, New York, United States

Outcomes

Primary Outcomes

Liebowitz Social Anxiety Scale (LSAS)

Clinical Global Impression-Change (CGI-C)

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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