NCT02051647

Brief Summary

To investigate whether copeptin levels increase upon a psychological stress (i.e. written examination) and whether copeptin levels measured immediately before the written examination predict success of the examination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

January 29, 2014

Last Update Submit

December 3, 2014

Conditions

Healthy

Keywords

medical studentsBasel University

Outcome Measures

Primary Outcomes (1)

  • Change in copeptin levels upon examination stress comparing copeptin levels prior and after examination

    4 hours

Secondary Outcomes (2)

  • Correlation between copeptin levels prior to an exam and exam success

    4 hours

  • Correlation to cortisol as the classical stress marker

    4 hours

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

42 healthy voluntary medical students studying in the 4th year at Basel University

You may qualify if:

  • Age over 18 years
  • Member of 4th year in medical course at Basel University

You may not qualify if:

  • Intake of any medication (except birth control pill)
  • BMI over 30kg/m2
  • Evidence of acute disease
  • History of chronic illness, including chronic psychiatric disease
  • Anamnestic certain or assumed pregnancy
  • Regularly smoking students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hopsital Basel

Basel, Switzerland

Location

Related Publications (1)

  • Urwyler SA, Schuetz P, Sailer C, Christ-Crain M. Copeptin as a stress marker prior and after a written examination--the CoEXAM study. Stress. 2015 Jan;18(1):134-7. doi: 10.3109/10253890.2014.993966. Epub 2015 Jan 8.

    PMID: 25472823DERIVED

Biospecimen

Serum, Li-Heparin

Study Officials

  • Mirjam Christ-Crain, Prof.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2014

First Posted

January 31, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

CH(1)