Mineralocorticoid Receptor in the Treatment of Severe Depression

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Treatments: Citalopram; Fludrocortisone; Mineralocorticoids; Spironolactone

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