NCT01648998

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 depression

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

1.1 years

First QC Date

May 23, 2012

Last Update Submit

February 23, 2014

Conditions

Depression

Keywords

Mineralocorticoid receptorFludrocortisoneInformation ProcessingCognitionDepression

Outcome Measures

Primary Outcomes (2)

  • Accuracy to recognize emotions in facial expressions

    This primary outcome is measured by performing the Facial Expression Recognition Task (FERT).

    2 hrs after intake fludrocortisone or placebo

  • Explicit memory for positive and negative information

    This primary outcome is measured by the Emotional categorization and Memory(EMT)task. This task consists of two parts, the encoding and recall.

    2 hrs after intake of fludrocortisone or placebo

Secondary Outcomes (1)

  • Subjective mood states

    2 hrs after intake fludrocortisone or placebo

Study Arms (2)

Fludrocortisone

EXPERIMENTAL

Fludrocortisone 500 mg in capsule

Drug: Fludrocortisone

Placebo

PLACEBO COMPARATOR

Placebo capsule, single dose, main ingredient lactose

Drug: Placebo

Interventions

FludrocortisoneDRUG

single dose 500 mg, capsule

Also known as: Florinef
Fludrocortisone
PlaceboDRUG
Also known as: Placebo comparator
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Fluent in Dutch
  • Age 18-35 yrs
  • BMI 18 to 30 kg/m2
  • Northwestern European ancestry

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University - Institute of Psychology

Leiden, South Holland, 2333 AK, Netherlands

Location

Related Publications (5)

  • Otte C, Hinkelmann K, Moritz S, Yassouridis A, Jahn H, Wiedemann K, Kellner M. Modulation of the mineralocorticoid receptor as add-on treatment in depression: a randomized, double-blind, placebo-controlled proof-of-concept study. J Psychiatr Res. 2010 Apr;44(6):339-46. doi: 10.1016/j.jpsychires.2009.10.006. Epub 2009 Nov 11.

    PMID: 19909979BACKGROUND

  • Klok MD, Vreeburg SA, Penninx BW, Zitman FG, de Kloet ER, DeRijk RH. Common functional mineralocorticoid receptor polymorphisms modulate the cortisol awakening response: Interaction with SSRIs. Psychoneuroendocrinology. 2011 May;36(4):484-94. doi: 10.1016/j.psyneuen.2010.07.024. Epub 2010 Sep 29.

    PMID: 20884124BACKGROUND

  • Harmer CJ, Goodwin GM, Cowen PJ. Why do antidepressants take so long to work? A cognitive neuropsychological model of antidepressant drug action. Br J Psychiatry. 2009 Aug;195(2):102-8. doi: 10.1192/bjp.bp.108.051193.

    PMID: 19648538BACKGROUND

  • Buckley TM, Mullen BC, Schatzberg AF. The acute effects of a mineralocorticoid receptor (MR) agonist on nocturnal hypothalamic-adrenal-pituitary (HPA) axis activity in healthy controls. Psychoneuroendocrinology. 2007 Sep-Nov;32(8-10):859-64. doi: 10.1016/j.psyneuen.2007.05.016. Epub 2007 Jul 30.

    PMID: 17666187BACKGROUND

  • Klok MD, Alt SR, Irurzun Lafitte AJ, Turner JD, Lakke EA, Huitinga I, Muller CP, Zitman FG, de Kloet ER, Derijk RH. Decreased expression of mineralocorticoid receptor mRNA and its splice variants in postmortem brain regions of patients with major depressive disorder. J Psychiatr Res. 2011 Jul;45(7):871-8. doi: 10.1016/j.jpsychires.2010.12.002. Epub 2010 Dec 30.

    PMID: 21195417BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Fludrocortisonefludrocortisone acetate

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

HydrocortisonePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Willem van der Does, Professor

    Leiden University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2012

First Posted

July 25, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

February 25, 2014

Record last verified: 2014-02

Locations

NL(1)