The effect of fludrocortisone on the processing of personally relevant information by healthy people.
- Conditions
- one.Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]
- Registration Number
- EUCTR2011-005205-71-NL
- Lead Sponsor
- eiden University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
- Females
- Age 18-35yrs
- BMI between 18 and 30
- Fluent in Dutch
- North-West European ancestry
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Major physical illness (infections, diabetes, thyroid disease, epilepsy, multiple sclerosis, pituitary disease or any other serious medical condition).
- Hypertension or history of stroke. Increased blood clot formation.
- Any current or past psychiatric disorder.
- Use of medication likely to interfere with the study (e.g., benzodiazepines, St John’s Wort).
- Pregnancy or breastfeeding.
- Use of soft drugs (hash, marijuana) in the three months prior to the study.
- Any hard drug use during life time (including XTC).
- Alcohol use of more than 14 units per week or more than 4 units on any day during the week prior to the study.
- Regular smoker during past year or use of any nicotine products during past month
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 2 hrs after intervention ;Main Objective: To determine the initial emotional and cognitive effects of MR-stimulation by acute administration of the specific MR-agonist fludrocortisone;Secondary Objective: None. ;Primary end point(s): - Accuracy of recognition of facial expressions of emotions<br>- Memory for positive vs negative information
- Secondary Outcome Measures
Name Time Method Secondary end point(s): None. ;Timepoint(s) of evaluation of this end point: not applicable