Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125554
Status:
COMPLETED
Last Update Posted:
2005-08-12
First Post:
2005-07-29
Brief Title:
Metyrapone as Additive Treatment in Major Depression
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
Double-Blind Placebo Controlled Trial of Metyrapone as Augmenting Agent in the Treatment of Major Depression
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test whether metyrapone is an effective and safe augmenting agent in the treatment of major depression
Detailed Description:
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
Administration of CRH-antagonists
Administration of glucocorticoid-receptor-antagonists and
Treatment with steroid-synthesis inhibitors like ketoconazole aminogluthethimide or metyrapone
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 GRMR 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
Administration of CRH-antagonists
Administration of glucocorticoid-receptor-antagonists and
Treatment with steroid-synthesis inhibitors like ketoconazole aminogluthethimide or metyrapone
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 GRMR 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None