Skip to content

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 men

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 men - RELAX study

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31720
Enrollment
24
Registered
2008-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anxiety disorders impaired stress responses

Interventions

6. Interventions 6.1 Telemetry pill All participants receive and ingest a telemetry pill (Vitalsense Minimitter, size 2.3 x 0.87 cm) on the day of the TSST, at least 2 hours before commencing the T

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male students over 18

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
7. Outcome measures 7.1 Primary outcome measure The primary outcome measure is the reduction of the stress-induced hyperthermia response during/after the TSST.

Secondary

MeasureTime frame
7. Outcome measures 7.2 Secondary outcome measures The Secondary outcome measures are - Blood pressure during the TSST - Correlation of saliva cortisol levels with the stress-induced hyperthermia response - Correlation of the stress-induced hyperthermia response and stress-inuduced blood pressure response with a set of anxiety/stress questionnaires

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)