Fludrocortisone and Information Processing in Healthy Volunteers

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Stimulating the mineralocorticoid receptor (MR) may restore a disturbed balance as seen in depression. In this double-blind, randomized, placebo-controlled trial the investigators will test the effects of a single dose (500mg) fludrocortisone, an MR-agonist, on the information processing in healthy female volunteers (N = 2x20).

The investigators want to investigate whether the acute administration of fludrocortisone (FC) in healthy females enhances the appraisal of emotional information related to depression, hypothesizing that:

• FC relative to placebo selectively improves the recognition of happy and fearful faces:

resulting in more correct responses and faster RTs.

• FC induces a bias towards more positive self-description and an improved memory for positive information.

Female participants were selected because the haplotype MRI180V is related to depression vulnerability in women, not in men. If the effects of fludrocortisone are comparable to the effects of antidepressants on the same tests and the same population, it might be a first indication that fludrocortisone may function as an antidepressant.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Leiden University Medical Center
• Treatments: Fludrocortisone

Criteria

Inclusion Criteria:

• Fluent in Dutch

• Age 18-35 yrs

• BMI 18 to 30 kg/m2

• Northwestern European ancestry

Exclusion Criteria:

• Known contra-indications for fludrocortisone use:

• Allergy to fludrocortisone.

• Ulcus ventriculi et duodeni.

• Acute infectious processes; viral infections

• Tropical worm infections.

• Vaccination with living virus

• Major physical illness, such as diabetes, thyroid disease, epilepsy, multiple sclerosis, pituitary disease, or any other serious medical condition.

• Hypertension or history of stroke. Increased blood clot formation.

• Major infections.

• 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.

• History of regular (more than once per month during three or more months) use of hard drugs (including XTC) or any use during past month.

• Alcohol use of more than 14 units per week or more than 4 units on any day during the week prior to the study or during the study period.

• Regular smoker during past year or use of nicotine product during past week

• Participants will be tested outside their menstrual period (two days before until five days after start of period).