Mineralocorticoid Receptor in the Treatment of Severe Depression

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

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 Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: Drug: escitalopram; Drug: Spironolactone; Drug: fludrocortisone

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Hospital Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Christian Otte, MD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: February 22, 2006
• First Submitted That Met QC Criteria: February 22, 2006
• First Posted (Estimate): February 23, 2006

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Natriuretic Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Diuretics; Antidepressive Agents, Second-Generation; Hormone Antagonists; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Citalopram; Spironolactone; Fludrocortisone
• Other Study ID Numbers: OT 209/3-1