Mineralocorticoid Receptor in the Treatment of Severe Depression - Tabular View

Tracking Information

First Received Date ^ICMJE

February 22, 2006

Last Updated Date

June 9, 2008

Start Date ^ICMJE

December 2005

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00295347 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Mineralocorticoid Receptor in the Treatment of Severe Depression

Official Title ^ICMJE

Mineralocorticoid Receptor in the Treatment of Severe Depression: A Randomized, Double Blind, and Placebo Controlled Trial

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Major Depression

Intervention ^ICMJE

Drug: Spironolactone
Drug: fludrocortisone
Drug: escitalopram

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00295347

Responsible Party

Christian Otte, MD, University Hospital Hamburg-Eppendorf

Study ID Numbers ^ICMJE

OT 209/3-1

Study Sponsor ^ICMJE

Universitätsklinikum Hamburg-Eppendorf

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Christian Otte, MD

Universitätsklinikum Hamburg-Eppendorf

Information Provided By

Universitätsklinikum Hamburg-Eppendorf

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP