Mineralocorticoid Receptor in the Treatment of Severe Depression - Full Text View

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

MedlinePlus related topics:

Depression

Drug Information available for:

Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Fludrocortisone Fludrocortisone 21-acetate Spironolactone

U.S. FDA Resources

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

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

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

Study placed in the following topic categories:

Depression

Mental Disorders

Mood Disorders

Fludrocortisone

Depressive Disorder, Major

Dexetimide

Depressive Disorder

Citalopram

Serotonin

Spironolactone

Behavioral Symptoms

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Hormone Antagonists

Diuretics

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Psychotropic Drugs

Cardiovascular Agents

Serotonin Uptake Inhibitors

Pharmacologic Actions

Serotonin Agents

Aldosterone Antagonists

Natriuretic Agents

Therapeutic Uses

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on October 29, 2008

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