PET (Positron Emission Tomography)/Public Speaking Study With A Combination Of 2 Medications In Social Anxiety Patients

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Depressive Disorder and Anxiety Disorders

Treatments

Drug: paroxetine

Drug: vestipitant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00343707

NKP102280

Details and patient eligibility

About

This six-arm study is being conducted to measure the effect of a combination of paroxetine and vestipitant on the arousal induced by public speaking in Seasonal Effective Disorder (SAD) patients, using functional brain imaging readouts (i.e., WAT(Wave Analysis Technology) PET(Positron Emission Tomography)), after one or eight weeks of treatment. The effect of paroxetine alone after one or eight weeks of treatment will also be measured.

Full description

A double-blind, double dummy, placebo-controlled, randomised, parallel group positron emission tomography study to investigate the effects of a 8 week administration of vestipitant and paroxetine in combination or paroxetine alone on regional cerebral blood flow during a public speaking test in subjects affected by social anxiety disorder.

Enrollment

72 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Social phobic ambulatory subjects, defined according to DSM-IV criteria.
Must be capable of giving informed consent and can comply with the study requirements.
Women of childbearing potential must agree to acceptable method of birth control.

Exclusion criteria

Primary diagnosis within the past 6 months of other psychiatric conditions 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) findings.