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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
次要结局
- 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.