Mineralocorticoid Receptor in the Treatment of Severe Depression

Mineralocorticoid Receptor in the Treatment of Severe Depression: A Randomized, Double Blind, and Placebo Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00295347

Enrollment

Registered

2006-02-23

Start date

2005-12-31

Completion date

2008-06-30

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression

Brief summary

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.

Interventions

DRUGSpironolactone

DRUGfludrocortisone

DRUGescitalopram

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026