A Double-blind, Triple Dummy, Placebo-controlled, Randomised, Parallel Group Positron Emission Tomography Study to Investigate the Effects of a 8 Week Administration of GW597599 and Paroxetine Either Alone or in Combination on Regional Cerebral Blood Flow During a Public Speaking Test in Subjects Affected by Social Phobia.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Depressive Disorder and Anxiety Disorders
- Sponsor
- GlaxoSmithKline
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- To assess, by mean of Positron Emission Tomography, the degree of regional Cerebral Blood Flow in different brain regions involved in the emotional brain circuit during public speaking task before treatment and after eight weeks of treatment.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To assess, by mean of Positron Emission Tomography, the degree of regional Cerebral Blood Flow in different brain regions involved in the emotional brain circuit during public speaking task before treatment and after eight weeks of treatment.
Secondary Outcomes
- To assess symptomatic and physiological measures of anxiety induced by the public speaking task and social anxiety symptoms during eight weeks of treatment. To evaluate safety, tolerability and the effect on sexual function of treatment.