The Relax Study - REduction of the autonomic stress response with AnXiolytics A double blind randomized clinical trial of alprazolam vs. placebo on social stress-induced hyperthermia response in healthy me
Withdrawn
- Conditions
- anxiety disordersimpaired stress responses10002861
- Registration Number
- NL-OMON31720
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
healthy male students over 18
Exclusion Criteria
Exclusion criteria are: female gender, smoking more than 5 cigarettes a day, any psychiatric disorder, any significant medical condition including any gastrointestinal condition that would lead to a contraindication for the telemetric pill, participation in current psychological or psychopharmacological treatment, use of any medication which might influence autonomic response, including psychotropics, beta blockers, ACE inhibitors and any hormonal treatment. Acute exclusion criteria are: any acute illness, fever, having a severe cold, recent physical exertion within the last 2 hours, large meals.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>7. Outcome measures<br /><br>7.1 Primary outcome measure<br /><br>The primary outcome measure is the reduction of the stress-induced hyperthermia<br /><br>response during/after the TSST.</p><br>
- Secondary Outcome Measures
Name Time Method <p>7. Outcome measures<br /><br>7.2 Secondary outcome measures<br /><br>The Secondary outcome measures are<br /><br>- Blood pressure during the TSST<br /><br>- Correlation of saliva cortisol levels with the stress-induced hyperthermia<br /><br>response<br /><br>- Correlation of the stress-induced hyperthermia response and stress-inuduced<br /><br>blood pressure response with a set of anxiety/stress questionnaires</p><br>