Back to resultsMineralocorticoid Receptor in the Treatment of Severe Depression
Primary Purpose
Major Depression
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Spironolactone
fludrocortisone
escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression
Eligibility 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
Sites / Locations
- University Hospital Hamburg-Eppendorf
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00295347
First Posted
February 22, 2006
Last Updated
May 24, 2017
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT00295347
Brief Title
Mineralocorticoid Receptor in the Treatment of Severe Depression
Official Title
Mineralocorticoid Receptor in the Treatment of Severe Depression: A Randomized, Double Blind, and Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Type
Drug
Intervention Name(s)
fludrocortisone
Intervention Type
Drug
Intervention Name(s)
escitalopram
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Otte, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Mineralocorticoid Receptor in the Treatment of Severe Depression
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