Clinical trial NCT00273039: A Study Of A New Medicine (GW679769) For The Treatment Of Social Anxiety Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Social Anxiety Disorder
Anxiety Disorders
Keywords: Social Anxiety Disorder
Anxiety
Psychiatry
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS)
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: GSK Investigational Site
state: California
city: Burbank
country: United States
facility: GSK Investigational Site
state: California
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: North Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Smyrna
country: United States
facility: GSK Investigational Site
state: Georgia
city: Oakbrook Terrace
country: United States
facility: GSK Investigational Site
state: Illinois
city: Rockville
country: United States
facility: GSK Investigational Site
state: Maryland
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Lake Jackson
country: United States
facility: GSK Investigational Site
state: Texas
city: La Plata/Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Cordoba
country: Argentina
facility: GSK Investigational Site
state: Córdova
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Miramichi
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Providencia / Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: San José
country: Costa Rica
facility: GSK Investigational Site
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Mexico, D.F.
country: Mexico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: