A Study Of A New Medicine (GW679769) For The Treatment Of Social Anxiety Disorder

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

PHASE2

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-09-30

Brief Summary

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The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in subjects with Social Anxiety Disorder

Detailed Description

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Conditions

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Social Anxiety Disorder Anxiety Disorders

Keywords

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Social Anxiety Disorder Anxiety Psychiatry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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paroxetine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with Generalized Social Anxiety Disorder as the primary diagnosis.
* If female, must commit to consistent and correct use of an acceptable method of birth control.

Exclusion Criteria

* Patients with any other psychiatric disorder as a primary diagnosis or within 6 months prior to screening.
* Patients with Body Dysmophic Disorder, Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder.
* Patients who pose a current suicidal or homicidal risk or have made a suicide attempt within the past 6 months or have ever been homicidal.
* Patients who have a positive urine test at screen for illegal drug use and/or a history of substance abuse or dependence (alcohol or drugs) within the past 12 months.
* Patients with an unstable medical disorder.
* Female patients who are pregnant, lactating, or planning to become pregnant during a specified time during the study.
* Patients who are taking other psychoactive medications.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

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Identifier Type: -

Identifier Source: org_study_id

A Study Of A New Medicine (GW679769) For The Treatment Of Social Anxiety Disorder

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

paroxetine

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

GlaxoSmithKline

Responsible Party

Principal Investigators

GSK Clinical Trials

Locations

GSK Investigational Site

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Countries

Study Documents

Document Type: Informed Consent Form

Document Type: Dataset Specification

Document Type: Annotated Case Report Form

Document Type: Study Protocol

Document Type: Individual Participant Data Set

Document Type: Statistical Analysis Plan

Document Type: Clinical Study Report

Related Links

Other Identifiers

NKF100110