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Mineralocorticoid Receptor in the Treatment of Severe Depression

NCT00295347 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2017-05-30

No results posted yet for this 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.

Conditions

Interventions

DRUG

Spironolactone

DRUG

fludrocortisone

DRUG

escitalopram

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Christian Otte, MD · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00295347 on ClinicalTrials.gov