IndividualityMR-STIMNCT02478034
Effects of Mineralocorticoid Receptor Stimulation on Cognition
A study testing Fludrocortisone in people with Individuality, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
In this study the effects of mineralocorticoid stimulation on social cognition will be investigated in healthy young individuals. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Individuality
- What is being tested?
- Fludrocortisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Mar 2016
- Phase
- Interventional
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- free of medication
- age 18 - 30
Who cannot join
- any medication
- severe illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effekte Von Fludrocortison Auf Soziale Kognition Und Gedächtnis Unter Berücksichtigung Von Geschlechtereffekten
In this study the effects of mineralocorticoid stimulation on social cognition will be investigated in healthy young individuals.
Read the detailed description
80 healthy young individuals (40 females and 40 male) will be recruited an randomized to either placebo or 0.4 mg Fludrocortison before testing. Tasks will on emotion recognition, Task Switch, visual spacial memory and decision making will be conducted.
- Conditions
- Individuality
- Being tested
- Fludrocortisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludrocortisoneOther
Also called Florinef (Squibb & Sons Limited)
effects of fludrocortisone on cognition compared to placebo
| Study group | Role | What they receive |
|---|---|---|
| fludrocortisone | Experimental | effects of fludrocortisone on cognition compared to placebo Receives: Other: Fludrocortisone |
| Placebo | Placebo comparator | effects of fludrocortisone on cognition compared to placebo Receives: Other: Fludrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
social cognition
computer based tests: emotion recognition
Measured: 25 min
Secondary outcomes (2)
memory
computer based test on visuospacial memory
Measured: 20 min
decision making
computer based tests: BART
Measured: 25 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IndividualityStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katja Wingenfeld, Charite University, Berlin, Germany
- Investigators
- Katja Wingenfeld, PhD, Principal investigator, Charité University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478034
- Sponsor's protocol ID
- WI-CO-2
- Acronym
- MR-STIM
- Status last verified
- Mar 2016
- First submitted
- 11 Jun 2015
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effekte Von Fludrocortison Auf Soziale Kognition Und Gedächtnis Unter Berücksichtigung Von Geschlechtereffekten
- ClinicalTrials.gov ID
- NCT02478034
- Acronym / sponsor ID
- MR-STIM / WI-CO-2
- Conditions
- Individuality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Jun 2015 (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.
In this study the effects of mineralocorticoid stimulation on social cognition will be investigated in healthy young individuals.
Detailed description
80 healthy young individuals (40 females and 40 male) will be recruited an randomized to either placebo or 0.4 mg Fludrocortison before testing. Tasks will on emotion recognition, Task Switch, visual spacial memory and decision making will be conducted.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fludrocortisone | Experimental | Other: Fludrocortisoneeffects of fludrocortisone on cognition compared to placebo |
| Placebo | Placebo comparator | Other: Fludrocortisoneeffects of fludrocortisone on cognition compared to placebo |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- free of medication
- age 18 - 30
Key exclusion criteria (2 listed)
- any medication
- severe illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FludrocortisoneAlso: Florinef (Squibb & Sons Limited)effects of fludrocortisone on cognition compared to placebo | Other | Placebo, fludrocortisone |
Primary outcome
social cognition
Time frame: 25 min
computer based tests: emotion recognition
2 secondary outcomes
memory
Time frame: 20 min
decision making
Time frame: 25 min
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 7 Mar 2016.
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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.
Katja Wingenfeld, PhD principal investigator
Charité University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fludrocortisone in people with Individuality, run by Charite University, Berlin, Germany at 1 site in Germany.
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 2 inclusion and 2 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 7 Mar 2016. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
social cognition (time frame: 25 min). 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 7 Mar 2016.