- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02478034
Effects of Mineralocorticoid Receptor Stimulation on Cognition (MR-STIM)
March 4, 2016 updated by: Katja Wingenfeld, Charite University, Berlin, Germany
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany
- Charité University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- free of medication
- age 18 - 30
Exclusion Criteria:
- any medication
- severe illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: fludrocortisone
effects of fludrocortisone on cognition compared to placebo
|
effects of fludrocortisone on cognition compared to placebo
Other Names:
|
Placebo Comparator: Placebo
effects of fludrocortisone on cognition compared to placebo
|
effects of fludrocortisone on cognition compared to placebo
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
social cognition
Time Frame: 25 min
|
computer based tests: emotion recognition
|
25 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
memory
Time Frame: 20 min
|
computer based test on visuospacial memory
|
20 min
|
decision making
Time Frame: 25 min
|
computer based tests: BART
|
25 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Katja Wingenfeld, PhD, Charité University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
June 11, 2015
First Submitted That Met QC Criteria
June 18, 2015
First Posted (Estimate)
June 23, 2015
Study Record Updates
Last Update Posted (Estimate)
March 7, 2016
Last Update Submitted That Met QC Criteria
March 4, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WI-CO-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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