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A Combination Therapy In Patients With Social Anxiety Disorder

Primary Purpose

Social Phobia

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

About this trial

This is an interventional treatment trial for Social Phobia focused on measuring anxiety, Social Anxiety Disorder, SAD

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Primary diagnosis of Generalised Social Anxiety Disorder as defined in DSM-IV.
  • Capable of giving informed consent and willing to comply with the study requirements.
  • Women of childbearing potential must agree to one of a number of defined acceptable methods of birth control.

Exclusion criteria:

  • Primary diagnosis within the past 6 months of another Axis 1 disorder such as Major Depression or another anxiety disorder.
  • Use of medications for a psychiatric condition including herbals in the past 2-12 weeks according to medication type.
  • Subjects who, in the investigator's judgement pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months.
  • Subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine).
  • Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG).

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

Outcomes

Primary Outcome Measures

Change in score on a Social Anxiety Disorder rating scale following 12 weeks of treatment.

Secondary Outcome Measures

Change in score on a number of rating scales following 12 weeks of treatment assessing symptomatic, behavioural and functional parameters which together provide a more complete description of the disorder.

Full Information

First Posted
August 29, 2005
Last Updated
September 13, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00403962
Brief Title
A Combination Therapy In Patients With Social Anxiety Disorder
Official Title
A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Fixed Dose Study Comparing the Efficacy and Safety of GW597599/Paroxetine Combination or Paroxetine Monotherapy to Placebo in Patients With Social Anxiety Disorder (SAD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of Vestipitant and Paroxetine in patients with Social Anxiety Disorder (SAD)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
Keywords
anxiety, Social Anxiety Disorder, SAD

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
vestipitant/paroxetine
Primary Outcome Measure Information:
Title
Change in score on a Social Anxiety Disorder rating scale following 12 weeks of treatment.
Secondary Outcome Measure Information:
Title
Change in score on a number of rating scales following 12 weeks of treatment assessing symptomatic, behavioural and functional parameters which together provide a more complete description of the disorder.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Primary diagnosis of Generalised Social Anxiety Disorder as defined in DSM-IV. Capable of giving informed consent and willing to comply with the study requirements. Women of childbearing potential must agree to one of a number of defined acceptable methods of birth control. Exclusion criteria: Primary diagnosis within the past 6 months of another Axis 1 disorder such as Major Depression or another anxiety disorder. Use of medications for a psychiatric condition including herbals in the past 2-12 weeks according to medication type. Subjects who, in the investigator's judgement pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months. Subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine). Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG).
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
Hilleroed
ZIP/Postal Code
3400
Country
Denmark
Facility Name
GSK Investigational Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
GSK Investigational Site
City
Koebenhavn K
ZIP/Postal Code
1256
Country
Denmark
Facility Name
GSK Investigational Site
City
Koebenhavn OE
ZIP/Postal Code
2100
Country
Denmark
Facility Name
GSK Investigational Site
City
Risskov
ZIP/Postal Code
8240
Country
Denmark
Facility Name
GSK Investigational Site
City
Skanderborg
ZIP/Postal Code
8660
Country
Denmark
Facility Name
GSK Investigational Site
City
Soroe
ZIP/Postal Code
4180
Country
Denmark
Facility Name
GSK Investigational Site
City
Huettenberg
State/Province
Hessen
ZIP/Postal Code
35625
Country
Germany
Facility Name
GSK Investigational Site
City
Achim
State/Province
Niedersachsen
ZIP/Postal Code
28832
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13053
Country
Germany
Facility Name
GSK Investigational Site
City
Bergen
ZIP/Postal Code
N-5068
Country
Norway
Facility Name
GSK Investigational Site
City
Hamar
ZIP/Postal Code
N-2317
Country
Norway
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
0364
Country
Norway
Facility Name
GSK Investigational Site
City
Sandvika
ZIP/Postal Code
1338
Country
Norway
Facility Name
GSK Investigational Site
City
Bloemfontein
Country
South Africa
Facility Name
GSK Investigational Site
City
Tygerberg
ZIP/Postal Code
7505
Country
South Africa

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
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKP103401
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
NKP103401
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKP103401
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
NKP103401
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
NKP103401
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
NKP103401
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
NKP103401
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

A Combination Therapy In Patients With Social Anxiety Disorder

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