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

Primary Purpose

Social Anxiety Disorder, Anxiety Disorders

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
paroxetine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Social Anxiety Disorder, Anxiety, Psychiatry

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

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.

Full Information

First Posted
January 5, 2006
Last Updated
October 24, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00273039
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder, Anxiety Disorders
Keywords
Social Anxiety Disorder, Anxiety, Psychiatry

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paroxetine
Primary Outcome Measure Information:
Title
The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS)
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
GSK Investigational Site
City
Burbank
State/Province
California
ZIP/Postal Code
91506
Country
United States
Facility Name
GSK Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
GSK Investigational Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
GSK Investigational Site
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
GSK Investigational Site
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
GSK Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10024
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19149
Country
United States
Facility Name
GSK Investigational Site
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
GSK Investigational Site
City
La Plata/Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
B1896AEH
Country
Argentina
Facility Name
GSK Investigational Site
City
Cordoba
State/Province
Córdova
ZIP/Postal Code
5000
Country
Argentina
Facility Name
GSK Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1122AAN
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1062ABF
Country
Argentina
Facility Name
GSK Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
Country
Canada
Facility Name
GSK Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
Facility Name
GSK Investigational Site
City
Miramichi
State/Province
New Brunswick
ZIP/Postal Code
E1V 3G5
Country
Canada
Facility Name
GSK Investigational Site
City
Providencia / Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
GSK Investigational Site
City
Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
7580208
Country
Chile
Facility Name
GSK Investigational Site
City
San José
Country
Costa Rica
Facility Name
GSK Investigational Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64170
Country
Mexico
Facility Name
GSK Investigational Site
City
Mexico, D.F.
ZIP/Postal Code
03740
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKF100110
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKF100110
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKF100110
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKF100110
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKF100110
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKF100110
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKF100110
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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