A Combination Therapy In Patients With Social Anxiety Disorder - Full Text View

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

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Vestipitant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, 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:	November 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 Investigational Site
Skanderborg, Denmark, 8660
GSK Investigational Site
Soroe, Denmark, 4180
GSK Investigational Site
Koebenhavn K, Denmark, 1256
GSK Investigational Site
Koebenhavn OE, Denmark, 2100
GSK Investigational Site
Hilleroed, Denmark, 3400
GSK Investigational Site
Hvidovre, Denmark, 2650
GSK Investigational Site
Risskov, Denmark, 8240
Germany
GSK Investigational Site
Berlin, Germany, 10629
GSK Investigational Site
Berlin, Germany, 13053
Germany, Hessen
GSK Investigational Site
Huettenberg, Hessen, Germany, 35625
Germany, Niedersachsen
GSK Investigational Site
Achim, Niedersachsen, Germany, 28832
Norway
GSK Investigational Site
Oslo, Norway, 0364
GSK Investigational Site
Bergen, Norway, N-5068
GSK Investigational Site
Hamar, Norway, N-2317
GSK Investigational Site
Sandvika, Norway, 1338
South Africa
GSK Investigational Site
Bloemfontein, South Africa
GSK Investigational Site
TYGERBERG, South Africa, 7505

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, PhD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	NKP103401
Study First Received:	August 29, 2005
Last Updated:	October 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 January 14, 2009