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Trial record 6 of 490 for:    ESCITALOPRAM AND Antagonists

Mineralocorticoid Receptor in the Treatment of Severe Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00295347
Recruitment Status : Completed
First Posted : February 23, 2006
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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.

Condition or disease Intervention/treatment Phase
Major Depression Drug: Spironolactone Drug: fludrocortisone Drug: escitalopram Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Mineralocorticoid Receptor in the Treatment of Severe Depression: A Randomized, Double Blind, and Placebo Controlled Trial
Study Start Date : December 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00295347

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University Hospital Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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Principal Investigator: Christian Otte, MD Universitätsklinikum Hamburg-Eppendorf

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf Identifier: NCT00295347     History of Changes
Other Study ID Numbers: OT 209/3-1
First Posted: February 23, 2006    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Anti-Inflammatory Agents