Mineralocorticoid Receptor in the Treatment of Severe Depression

Universitätsklinikum Hamburg-Eppendorf65 enrolled

Overview

The proposed research aims to compare the onset of action and the efficacy of fludrocortisone, a mineralocorticoid receptor agonist vs. spironolactone, a mineralocorticoid antagonist, vs. placebo as augmentation to a selective serotonin reuptake inhibitor (SSRI) in 65 inpatients with severe depression. The study will also explore the utility of the hypothalamic-pituitary-adrenal (HPA) axis in predicting treatment response. The study will be a 5-week randomized and double-blind trial of fludrocortisone vs. spironolactone vs. placebo during three years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Major Depression

Interventions

SpironolactoneDRUG

fludrocortisoneDRUG

escitalopramDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Depressed male and female inpatients according to DSM-IV * Age between 18 and 70 years * Minimum of 17-items Hamilton Depression Score of 18 * Informed consent signed Exclusion Criteria: * Relevant medical or neurological disorders * Pregnancy or unsure contraception * Relevant psychiatric comorbidity * Active alcohol or other substance abuse/dependance * Contraindications to SSRI, fludrocortisone, or spironolactone * Steroid medication

Locations (1)

University Hospital Hamburg-Eppendorf

Hamburg, Germany

Data from ClinicalTrials.gov

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