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

NCT ID: NCT00208741

Last Updated: 2013-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2003-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Social Anxiety Disorder

Keywords

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Social Anxiety Disorder Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Gabitril

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cephalon

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip T Ninan, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University School of Medicine

Atlanta, Georgia, United States

Site Status

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

Long Island City, New York, United States

Site Status

Columbia/New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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0337-2002

Identifier Type: -

Identifier Source: org_study_id