A Combination Therapy In Patients With Social Anxiety Disorder

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Paroxetine; Vestipitant

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).