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)

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)

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).