Mineralocorticoid Receptor in the Treatment of Severe Depression

This study has been completed.

First Received: February 22, 2006 Last Updated: June 9, 2008 History of Changes

Sponsor:	Universitätsklinikum Hamburg-Eppendorf
Information provided by:	Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:	NCT00295347

Purpose

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.

Condition	Intervention
Major Depression	Drug: Spironolactone Drug: fludrocortisone Drug: escitalopram

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Mineralocorticoid Receptor in the Treatment of Severe Depression: A Randomized, Double Blind, and Placebo Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Spironolactone Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate Fludrocortisone Fludrocortisone 21-acetate

U.S. FDA Resources

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Estimated Enrollment:	65
Study Start Date:	December 2005
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295347

Locations

Germany
University Hospital Hamburg-Eppendorf
Hamburg, Germany, 20246

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

Principal Investigator:

Christian Otte, MD

Universitätsklinikum Hamburg-Eppendorf

More Information

No publications provided

Responsible Party:	University Hospital Hamburg-Eppendorf ( Christian Otte, MD )
Study ID Numbers:	OT 209/3-1
Study First Received:	February 22, 2006
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00295347 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Mineralocorticoids
Diuretics
Physiological Effects of Drugs
Psychotropic Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Depressive Disorder, Major
Hormones
Mental Disorders
Therapeutic Uses
Fludrocortisone

Antidepressive Agents, Second-Generation
Antidepressive Agents
Depression
Cardiovascular Agents
Depressive Disorder
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Spironolactone
Behavioral Symptoms
Serotonin Agents
Aldosterone Antagonists
Natriuretic Agents
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009