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

GlaxoSmithKline1 site in 1 country242 target enrollmentAugust 2005

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Social Anxiety Disorder
Sponsor: GlaxoSmithKline
Enrollment: 242
Locations: 1
Primary Endpoint: The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS)
Status: Completed
Last Updated: 9 years ago

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

Registry

clinicaltrials.gov

Start Date

August 2005

End Date

September 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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.

•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.

The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS)

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.