A Study Of A New Medicine (GW679769) For The Treatment Of Social Anxiety Disorder
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
1 other identifier
interventional
242
6 countries
27
Brief Summary
The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in subjects with Social Anxiety Disorder
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2005
Shorter than P25 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 5, 2006
CompletedFirst Posted
Study publicly available on registry
January 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedOctober 26, 2016
October 1, 2016
1.1 years
January 5, 2006
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS)
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (27)
GSK Investigational Site
Beverly Hills, California, 90210, United States
GSK Investigational Site
Burbank, California, 91506, United States
GSK Investigational Site
Jacksonville, Florida, 32216, United States
GSK Investigational Site
Miami, Florida, 33125, United States
GSK Investigational Site
North Miami, Florida, 33161, United States
GSK Investigational Site
Orlando, Florida, 32806, United States
GSK Investigational Site
Smyrna, Georgia, 30080, United States
GSK Investigational Site
Oakbrook Terrace, Illinois, 60181, United States
GSK Investigational Site
Rockville, Maryland, 20852, United States
GSK Investigational Site
New York, New York, 10021, United States
GSK Investigational Site
New York, New York, 10024, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73104, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19149, United States
GSK Investigational Site
Lake Jackson, Texas, 77566, United States
GSK Investigational Site
Buenos Aires, Buenos Aires, C1122AAN, Argentina
GSK Investigational Site
La Plata/Buenos Aires, Buenos Aires, B1896AEH, Argentina
GSK Investigational Site
Córdoba, Córdoba Province, 5000, Argentina
GSK Investigational Site
Buenos Aires, C1062ABF, Argentina
GSK Investigational Site
Edmonton, Alberta, T6L 5X8, Canada
GSK Investigational Site
Kelowna, British Columbia, V1Y 2H4, Canada
GSK Investigational Site
Miramichi, New Brunswick, E1V 3G5, Canada
GSK Investigational Site
Providencia / Santiago, Región Metro de Santiago, 7500710, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7580208, Chile
GSK Investigational Site
San José, Provincia de San José, Costa Rica
GSK Investigational Site
San José, Costa Rica
GSK Investigational Site
Monterrey, Nuevo León, 64170, Mexico
GSK Investigational Site
Mexico City, 03740, Mexico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2006
First Posted
January 9, 2006
Study Start
August 1, 2005
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
October 26, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.