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Sponsored by: |
Universitätsklinikum Hamburg-Eppendorf |
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Information provided by: | Universitätsklinikum Hamburg-Eppendorf |
ClinicalTrials.gov Identifier: | NCT00125554 |
The purpose of this study is to test whether metyrapone is an effective and safe augmenting agent in the treatment of major depression.
Condition | Intervention | Phase |
---|---|---|
Major Depressive Disorder |
Drug: Metyrapone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Placebo Controlled Trial of Metyrapone as Augmenting Agent in the Treatment of Major Depression |
Estimated Enrollment: | 63 |
Study Start Date: | May 1998 |
Estimated Study Completion Date: | July 2001 |
The investigators' understanding of the neuroendocrine pathophysiology of depression has made significant progress in recent years, which should help to develop new remedies. Alterations of the hypothalamic-pituitary-adrenocortical (HPA) axis are the most consistent pathological endocrine findings in depression. Hence, attempts have been made to treat depression by directly targeting HPA-axis activity. Currently, three major pathways are investigated:
The investigators' aim was to conduct the first prospective, randomized, placebo-controlled, double-blind clinical trial of metyrapone as additive treatment in depression. Metyrapone was preferred, since this compound inhibits selectively the 11β-hydroxylase and the 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD-1), thereby exerting direct effects within the central nervous system (CNS). The additive approach was applied because the intended inclusion of severely depressed patients made a pure placebo group ethically challenging. Furthermore, the continuous use of an antidepressant allowed a standardized follow up after the double-blind period.
The hypotheses to be tested were, whether metyrapone exerts potentiating effects during a standard antidepressant therapy and whether an earlier onset-of-action and an improved overall and sustained treatment response can be achieved. Since GR/MR distribution as well as 11β-HSD-1 activities are subject to sexual dimorphism in humans, the sample was prospectively stratified for gender and balanced for treatment with two selected serotonergic antidepressants, allowing further analysis of gender effects and neuroendocrine treatment effects.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Participants were randomly assigned to a study group if they met these criteria.
Germany | |
Dept. of Psychiatry and Psychotherapy, UKE | |
Hamburg, Germany, 20246 |
Study Director: | Holger Jahn, MD | University Hospital Hamburg-Eppendorf, Germany |
Study ID Numbers: | HH-PSY-ja-007 |
Study First Received: | July 29, 2005 |
Last Updated: | August 11, 2005 |
ClinicalTrials.gov Identifier: | NCT00125554 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Clinical trial double-blind randomized placebo-controlled trial metyrapone Major Depression |
Depression Metyrapone Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions |