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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00273039

Collaborator

(none)

242

Enrollment

Locations

Duration (Months)

9.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Social Anxiety Disorder Anxiety Disorders	Drug: paroxetine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

242 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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

Study Start Date :

Aug 1, 2005

Actual Primary Completion Date :

Sep 1, 2006

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Beverly Hills	California	United States	90210
2	GSK Investigational Site	Burbank	California	United States	91506
3	GSK Investigational Site	Jacksonville	Florida	United States	32216
4	GSK Investigational Site	Miami	Florida	United States	33125
5	GSK Investigational Site	North Miami	Florida	United States	33161
6	GSK Investigational Site	Orlando	Florida	United States	32806
7	GSK Investigational Site	Smyrna	Georgia	United States	30080
8	GSK Investigational Site	Oakbrook Terrace	Illinois	United States	60181
9	GSK Investigational Site	Rockville	Maryland	United States	20852
10	GSK Investigational Site	New York	New York	United States	10021
11	GSK Investigational Site	New York	New York	United States	10024
12	GSK Investigational Site	Oklahoma City	Oklahoma	United States	73104
13	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19149
14	GSK Investigational Site	Lake Jackson	Texas	United States	77566
15	GSK Investigational Site	La Plata/Buenos Aires	Buenos Aires	Argentina	B1896AEH
16	GSK Investigational Site	Cordoba	Córdova	Argentina	5000
17	GSK Investigational Site	Buenos Aires		Argentina	C1122AAN
18	GSK Investigational Site	Ciudad Autonoma de Buenos Aires		Argentina	C1062ABF
19	GSK Investigational Site	Edmonton	Alberta	Canada	T6L 5X8
20	GSK Investigational Site	Kelowna	British Columbia	Canada	V1Y 2H4
21	GSK Investigational Site	Miramichi	New Brunswick	Canada	E1V 3G5
22	GSK Investigational Site	Providencia / Santiago	Región Metro De Santiago	Chile	7500710
23	GSK Investigational Site	Santiago	Región Metro De Santiago	Chile	7580208
24	GSK Investigational Site	San José		Costa Rica
25	GSK Investigational Site	Monterrey	Nuevo León	Mexico	64170
26	GSK Investigational Site	Mexico, D.F.		Mexico	03740