A Combination Therapy In Patients With Social Anxiety Disorder
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)
1 other identifier
interventional
204
4 countries
17
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2004
Shorter than P25 for phase_2
17 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
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 29, 2005
CompletedFirst Posted
Study publicly available on registry
November 27, 2006
CompletedSeptember 15, 2016
September 1, 2016
August 29, 2005
September 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in score on a Social Anxiety Disorder rating scale following 12 weeks of treatment.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (17)
GSK Investigational Site
Hilleroed, 3400, Denmark
GSK Investigational Site
Hvidovre, 2650, Denmark
GSK Investigational Site
Koebenhavn K, 1256, Denmark
GSK Investigational Site
Koebenhavn OE, 2100, Denmark
GSK Investigational Site
Risskov, 8240, Denmark
GSK Investigational Site
Skanderborg, 8660, Denmark
GSK Investigational Site
Soroe, 4180, Denmark
GSK Investigational Site
Hüttenberg, Hesse, 35625, Germany
GSK Investigational Site
Achim, Lower Saxony, 28832, Germany
GSK Investigational Site
Berlin, State of Berlin, 10629, Germany
GSK Investigational Site
Berlin, State of Berlin, 13053, Germany
GSK Investigational Site
Bergen, N-5068, Norway
GSK Investigational Site
Hamar, N-2317, Norway
GSK Investigational Site
Oslo, 0364, Norway
GSK Investigational Site
Sandvika, 1338, Norway
GSK Investigational Site
Bloemfontein, South Africa
GSK Investigational Site
Tygerberg, 7505, South Africa
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
August 29, 2005
First Posted
November 27, 2006
Study Start
November 1, 2004
Study Completion
August 1, 2005
Last Updated
September 15, 2016
Record last verified: 2016-09
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.