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...
Date First Received: February 22, 2006
Last Updated: June 9, 2008
Verified by: Universitätsklinikum Hamburg-Eppendorf, June 2008
Clinical Trial Phase: N/A | Start Date: December 2005
Overall Status: Completed
Estimated Enrollment: 65
Brief Summary
Official Title: “Mineralocorticoid Receptor in the Treatment of Severe Depression: A Randomized, Double Blind, and Placebo Controlled Trial”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: June 2008
Intervention(s) in this Clinical Trial
- Drug: Spironolactone
- Drug: fludrocortisone
- Drug: escitalopram
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Clinical Trial Officials and Contacts
Christian Otte, MD Principal Investigator Universitätsklinikum Hamburg-Eppendorf
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00295347
Study ID Number: OT 209/3-1
ClinicalTrials.gov Identifier: NCT00295347
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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