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)”

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)

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: vestipitant/paroxetine

Primary Measures

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

Secondary 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.

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD, PhD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00403962

Study ID Number: NKP103401

ClinicalTrials.gov Identifier: NCT00403962

Health Authority: Germany: Federal Institute for Drugs and Medical Devices