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

Anxiety Disorders Clinical Trial

Official title:

A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects With Social Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273039
• Other study ID #: NKF100110
• Status: Completed
• Phase: Phase 2
• First received: January 5, 2006
• Last updated: October 24, 2016
• Start date: August 2005
• Est. completion date: September 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobia, Social
• Social Anxiety Disorder

Intervention

Drug:
• paroxetine

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires
Argentina	GSK Investigational Site	Cordoba	Córdova
Argentina	GSK Investigational Site	La Plata/Buenos Aires	Buenos Aires
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Kelowna	British Columbia
Canada	GSK Investigational Site	Miramichi	New Brunswick
Chile	GSK Investigational Site	Providencia / Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Costa Rica	GSK Investigational Site	San José
Mexico	GSK Investigational Site	Mexico, D.F.
Mexico	GSK Investigational Site	Monterrey	Nuevo León
United States	GSK Investigational Site	Beverly Hills	California
United States	GSK Investigational Site	Burbank	California
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Lake Jackson	Texas
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	North Miami	Florida
United States	GSK Investigational Site	Oakbrook Terrace	Illinois
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Rockville	Maryland
United States	GSK Investigational Site	Smyrna	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Chile,  Costa Rica,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS)
Secondary	Secondary outcome measures include the change from baseline in the following scales: the Clinical Global Impression-Global Improvement, the Clinical Global Impression -Severity of Illness, and the Sheehan Disability Scale.

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.