A Study To Compare The Putative Anxiolytic Effect Of 2 New Drugs In Subjects With Social Anxiety Disorder
Phase 1
Completed
- Conditions
- Social Phobia
- Interventions
- Registration Number
- NCT00555139
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
To compare by neuroimaging techniques and public speaking, the way social anxiety patients respond after the administration of GW876008, GSK561679, alprazolam and placebo
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description GW876008 GW876008 tablet 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. GW876008 alprazolam 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. GW876008 Placebo 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. GSK561679 GSK561679 tablet 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. GSK561679 Placebo 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. GSK561679 alprazolam 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.
- Primary Outcome Measures
Name Time Method 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. over 6 weeks
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
GSK Investigational Site
🇪🇸Terrassa - Barcelona, Spain