Mineralocorticoid Receptor in the Treatment of Severe Depression

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295347
• Other study ID #: OT 209/3-1
• Status: Completed
• Phase: N/A
• First received: February 22, 2006
• Last updated: May 24, 2017
• Start date: December 2005
• Est. completion date: June 2008

Study information

• Verified date: May 2017
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• Spironolactone

• fludrocortisone

• escitalopram

Locations

Country	Name	City	State
Germany	University Hospital Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany,