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CompletedNCT00295347Updated May 30, 2017

Mineralocorticoid Receptor in the Treatment of Severe Depression

An interventional study of Spironolactone and fludrocortisone in Major Depression, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Major Depression
03

In context

Depressive Disorder, Major

2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.

This study's planned enrollment of 65 is below the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 415 studies on the registry; 85 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
65 participants (estimated)
06

Study locations

1 site
  • University Hospital Hamburg-Eppendorf
    Hamburg, 20246, Germany
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2005, a primary completion of Jun 2008 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2006
First posted
Feb 23, 2006
Start
Dec 2005
Primary completionActual
Jun 2008
CompletionActual
Jun 2008
Last update
May 30, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00295347
Responsible party
Sponsor
First posted
Feb 23, 2006
Start date
Dec 2005
Primary completion
Jun 2008
Completion
Jun 2008
Last update
May 30, 2017

Study contacts

Christian Otte, MD
principal investigator · Universitätsklinikum Hamburg-Eppendorf
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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