A Combination Therapy In Patients With Social Anxiety Disorder

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Social Phobia

Treatments

Drug: vestipitant/paroxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00403962

NKP103401

Details and patient eligibility

About

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)

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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).