Anxiety Disorders, Social Anxiety Disorder
Conditions
Keywords
Social Anxiety Disorder, Anxiety, Psychiatry
Brief summary
The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in subjects with Social Anxiety Disorder
Interventions
DRUGparoxetine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Argentina, Canada, Chile, Costa Rica, Mexico, United States
Outcome results
None listed