StressPsyCoNCT01866137
Copeptin During a Standardized Psychological Stress Test
An observational study of Stress, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of the PsyCo Study is to determine whether psychological Stress has an influence on copeptin levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2013to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy adults
Who may be able to join
- •Aged over 18 years
Who cannot join
- Intake of any kind of medication (except birth control pill)
- BMI >30 kg/m2
- Evidence of any acute illness
- History of chronic illness
- Baseline glucose level >7 mmol/l Baseline sodium level <135 mmol/l or >145 mmol/l
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
The aim of the PsyCo Study is to determine whether psychological Stress has an influence on copeptin levels.
Read the detailed description
healthy volunteers undergo the TSST and stress hormones as cortisol and copeptin are measured
- Conditions
- Stress
- Keywords
- Copeptin, psychological stress, The Trier Social Stress Test (TSST)
- Medical subject headings
- Diabetes Insipidus, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| no treatment | no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in copeptin levels after a psychological stress test in healthy volunteers
Measured: 30min before, at time point 0, +10, +20, +40, +60 after the psychological stress test
Secondary outcomes (1)
Changes in copeptin levels after a psychological stress test in patients with central diabetes insipidus
Measured: Timpepoint 0, +10, +20, +40, +60 after the psychological stress test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Prof.Dr.med., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866137
- Sponsor's protocol ID
- PsyCo
- Acronym
- PsyCo
- Status last verified
- Sep 2014
- First submitted
- 13 May 2013
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin During a Standardized Psychological Stress Test
- ClinicalTrials.gov ID
- NCT01866137
- Acronym / sponsor ID
- PsyCo / PsyCo
- Conditions
- Stress
- Keywords
- Copeptin, psychological stress, The Trier Social Stress Test (TSST)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the PsyCo Study is to determine whether psychological Stress has an influence on copeptin levels.
Detailed description
healthy volunteers undergo the TSST and stress hormones as cortisol and copeptin are measured
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment | – | –no treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy adults
Key inclusion criteria (1 listed)
- •Aged over 18 years
Key exclusion criteria (5 listed)
- Intake of any kind of medication (except birth control pill)
- BMI >30 kg/m2
- Evidence of any acute illness
- History of chronic illness
- Baseline glucose level >7 mmol/l Baseline sodium level <135 mmol/l or >145 mmol/l
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in copeptin levels after a psychological stress test in healthy volunteers
Time frame: 30min before, at time point 0, +10, +20, +40, +60 after the psychological stress test
1 secondary outcome
Changes in copeptin levels after a psychological stress test in patients with central diabetes insipidus
Time frame: Timpepoint 0, +10, +20, +40, +60 after the psychological stress test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirjam Christ-Crain, Prof.Dr.med. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in copeptin levels after a psychological stress test in healthy volunteers (time frame: 30min before, at time point 0, +10, +20, +40, +60 after the psychological stress test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2014.