Mineralocorticoid Receptor in the Treatment of Severe Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Spironolactone

Intervention Type DRUG

fludrocortisone

Intervention Type DRUG

escitalopram

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No