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A Combination Therapy In Patients With Social Anxiety Disorder

This study has been completed.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00403962
  Purpose

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)


Condition Intervention Phase
Social Anxiety Disorder
Drug: vestipitant/paroxetine
Phase II

MedlinePlus related topics:   Anxiety   

ChemIDplus related topics:   Paroxetine    Paroxetine hydrochloride    Paroxetine Mesylate    Vestipitant   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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)

Further study details as provided by GlaxoSmithKline:

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.

Estimated Enrollment:   204
Study Start Date:   October 2004

  Eligibility
Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403962

Locations
Denmark
GSK Clinical Trials Call Center    
      Kopenhagen K, Denmark, 1256
GSK Clinical Trials Call Center    
      Kopenhagen O, Denmark, 2100
GSK Clinical Trials Call Center    
      Hillerod, Denmark, 3400
GSK Clinical Trials Call Center    
      Risskov, Denmark, 8240
GSK Clinical Trials Call Center    
      Skanderborg, Denmark, DK-8660
GSK Clinical Trials Call Center    
      Hvidovre, Denmark, 2650
GSK Clinical Trials Call Center    
      Soro, Denmark, 4180
Germany
GSK Clinical Trials Call Center    
      Berlin, Germany, 10629
GSK Clinical Trials Call Center    
      Berlin, Germany, 13053
Germany, Hessen
GSK Clinical Trials Call Center    
      Huttenberg, Hessen, Germany, 35625
Germany, Niedersachsen
GSK Clinical Trials Call Center    
      Achim, Niedersachsen, Germany, 28832
Norway
GSK Clinical Trials Call Center    
      Bergen, Norway, N-5068
GSK Clinical Trials Call Center    
      Sandvika, Norway, 1338
GSK Clinical Trials Call Center    
      Oslo, Norway, N-0364
GSK Clinical Trials Call Center    
      Hamar, Norway, 2317
South Africa
GSK Clinical Trials Call Center    
      Tygerberg, South Africa, 7505
GSK Clinical Trials Call Center    
      Bloemfontein, South Africa

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials, MD, PhD     GlaxoSmithKline    
  More Information


Study ID Numbers:   NKP103401
First Received:   August 29, 2005
Last Updated:   January 15, 2008
ClinicalTrials.gov Identifier:   NCT00403962
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices;   South Africa: Medicines Control Council;   Norway: Norwegian Medicines Agency;   Denmark: Danish Medicines Agency

Keywords provided by GlaxoSmithKline:
anxiety  
Social Anxiety Disorder  
SAD  

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Phobic Disorders
Paroxetine
Serotonin

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on October 03, 2008




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