Double-blind, Randomized, Placebo and Alprazolam-controlled Three-period Crossover Incomplete Block Design Study to Compare Putative Anxiolytic-like fRMI Activity of GW876008 and GSK561679 After Single-dose Administration in Subjects With Social Anxiety Disorder (SAD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Changes of fMRI activation in amygdala of subjects with SAD during an emotional task after having received different compounds. Change in the VAS score in response to Public Speaking stress after having received different compounds.
研究概览
简要总结
To compare by neuroimaging techniques and public speaking, the way social anxiety patients respond after the administration of GW876008, GSK561679, alprazolam and placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GW876008
The subjects will be randomized to one of the six sequences A/B/D A/D/B B/A/D B/D/A D/A/B D/B/A across three treatment periods where A represents placebo, B represents GW876008 and D represents alprazolam.
干预措施: GW876008 tablet (Drug)
GW876008
The subjects will be randomized to one of the six sequences A/B/D A/D/B B/A/D B/D/A D/A/B D/B/A across three treatment periods where A represents placebo, B represents GW876008 and D represents alprazolam.
干预措施: alprazolam (Drug)
GW876008
The subjects will be randomized to one of the six sequences A/B/D A/D/B B/A/D B/D/A D/A/B D/B/A across three treatment periods where A represents placebo, B represents GW876008 and D represents alprazolam.
干预措施: Placebo (Drug)
GSK561679
The subjects will be randomized to one of the six sequences A/C/D A/D/C C/A/D C/D/A D/A/C D/C/A across three treatment periods where A represents placebo, C represents GSK561679 and D represents alprazolam.
干预措施: GSK561679 tablet (Drug)
GSK561679
The subjects will be randomized to one of the six sequences A/C/D A/D/C C/A/D C/D/A D/A/C D/C/A across three treatment periods where A represents placebo, C represents GSK561679 and D represents alprazolam.
干预措施: alprazolam (Drug)
GSK561679
The subjects will be randomized to one of the six sequences A/C/D A/D/C C/A/D C/D/A D/A/C D/C/A across three treatment periods where A represents placebo, C represents GSK561679 and D represents alprazolam.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes of fMRI activation in amygdala of subjects with SAD during an emotional task after having received different compounds. Change in the VAS score in response to Public Speaking stress after having received different compounds.
时间窗: over 6 weeks
次要结局
- Pk samples:(2 hours,4-5, 8hours post-dose (over 3 weeks, week 1,2&3))
- Cortisol, ACTH:(5hours 20min,5hours 35 min, 6hours & 7hours post dose (over 6 weeks, week 1,2,3 &6))
- Visual Analog Scale (VAS) measurements of distress(3.5-4hours, 4.5-5.3hours, 5hours 20mins, 5hours 35mins, 5hours 43mins after public speaking, 6hours, 6hours 20mins, 7hours (week 1,2, and 3))
- Changes of fMRI activation patterns in all brain areas in subjects with SAD during an emotional task or resting state. Changes of cortisol levels and other stress indicators in response to Public Speaking stress.(over 6 weeks)
- Maddox wing test.(Week 1, 2 and 3)
- Safety and tolerability will be evaluated by adverse event monitoring, physical examination, ECG, vital signs and laboratory parameters(Up to 6 weeks)
- questionnaire for sédation.(Week 1, 2 and 3)
- Indicators of physiological state during the fMRI session:(pre-dose, 5hours 20mins, 5hours 43mins, 6 hours, 6hours 20mins (over 6 weeks, week 1,2,3 &6))
- Heart rate (HR), Respiratory rate (RR), ventilation (pneumatic pletismography), and carbon dioxide percutaneous measurements monitored during the whole procedure (control and exploratory profile tests).(pre-dose, 5hours 20mins, 5hours 43mins, 6 hours, 6hours 20mins (over 6 weeks, week 1,2,3 &6))
- plasma levels of the various compounds to derive pharmacokinetic parameters(1hour, 2hours, 4-5hours, 8hours (week 1, 2 and 3))