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)”

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)

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 Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD, PhD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on February 12, 2012

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