Mineralocorticoid Receptor in the Treatment of Severe Depression
Information source: Universitätsklinikum Hamburg-Eppendorf
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression
Intervention: Spironolactone (Drug); fludrocortisone (Drug); escitalopram (Drug)
Phase: N/A
Status: Completed
Sponsored by: Universitätsklinikum Hamburg-Eppendorf Official(s) and/or principal investigator(s):
Christian Otte, MD, Principal Investigator, Affiliation: Universitätsklinikum Hamburg-Eppendorf
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.
Clinical Details
Official title: Mineralocorticoid Receptor in the Treatment of Severe Depression: A Randomized, Double Blind, and Placebo Controlled Trial
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
University Hospital Hamburg-Eppendorf, Hamburg 20246, Germany
Additional Information
Starting date: December 2005
Ending date: June 2008
Last updated: June 9, 2008
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