Mineralocorticoid Receptor in the Treatment of Severe Depression
Not Applicable
Completed
- Conditions
- Major Depression
- Registration Number
- NCT00295347
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Hamburg-Eppendorf
🇩🇪Hamburg, Germany