A Study Of A New Medicine (GW679769) For The Treatment Of Social Anxiety Disorder
Phase 2
Completed
- Conditions
- Anxiety DisordersSocial Anxiety Disorder
- Registration Number
- NCT00273039
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in subjects with Social Anxiety Disorder
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS)
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
GSK Investigational Site
🇲🇽Mexico, D.F., Mexico