Metyrapone as Additive Treatment in Major 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

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-05-31

Study Completion Date

2001-07-31

Brief Summary

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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

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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 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.

Conditions

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Major Depressive Disorder

Keywords

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Clinical trial double-blind randomized placebo-controlled trial metyrapone 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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Metyrapone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of major depressive disorder; single or recurrent according to DSM-IV criteria (296.2 or 296.3)
* A minimum baseline Hamilton score of 18 points on the Hamilton Rating Scale for Depression (HamD; 21-item version)
* Age from 18 to 75 years
* A drug free period of at least 5 days from antidepressants, antipsychotics, mood stabilizers and all other medications except for mild antihypertensive agents
* A negative urinary drug screening diagnosis

Exclusion Criteria

* A current DSM-IV diagnosis for other axis I psychiatric disorders
* Serious medical conditions, especially those associated with adrenal insufficiency
* Pregnancy, nursing or refusal to use a reliable method of birth control in women.

Participants were randomly assigned to a study group if they met these criteria.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Holger Jahn, MD

Role: STUDY_DIRECTOR

University Hospital Hamburg-Eppendorf, Germany

Locations

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Dept. of Psychiatry and Psychotherapy, UKE

Hamburg, City state of Hamburg, Germany

Site Status

Countries

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Germany

References

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Jahn H, Schick M, Kiefer F, Kellner M, Yassouridis A, Wiedemann K. Metyrapone as additive treatment in major depression: a double-blind and placebo-controlled trial. Arch Gen Psychiatry. 2004 Dec;61(12):1235-44. doi: 10.1001/archpsyc.61.12.1235.

Reference Type RESULT

PMID: 15583115 (View on PubMed)

Other Identifiers

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HH-PSY-ja-007

Identifier Type: -

Identifier Source: org_study_id