Metyrapone as additive treatment in patients with major depression - metyrapone study

• Conditions: unipolar depressive episode without psychotic features according to DSM-IV-TR; MedDRA version: 9.1Level: LLTClassification code 10027515Term: Metyrapone challenge test

• Registration Number: EUCTR2007-000137-19-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Outpatients with an unipolar major depressive disorder, according to DSM-IV-TR criteria, as main diagnosis.
- At least one antidepressant agent in adequate dose used for at least six weeks without adequate response, defined as < 50 % reduction on the Montgomery Äsberg Depression Rating Scale (MADRS) compared to baseline, or an inadequate response for at least three weeks, defined as a plateau-phase on the MADRS.
- A minimum of 21 points on the MADRS at baseline.
- Age between 18 and 65 years, male and female.
- Physically healthy non-pregnant patients on the basis of medical history, and if necessary physical examination, lab on blood, urine and pregnancy test. If the results are abnormal a patient can only be included if the investigators confirm that the deviations are not clinically significant/relevant.
- Use of adequate contraception in women in the fertile age.
- Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Outpatients with an unipolar major depressive disorder without psychotic features, according to DSM-IV-TR criteria, as main diagnosis.
- At least one antidepressant agent in adequate dose used for at least six weeks without adequate response, defined as < 50 % reduction on the MADRS compared to baseline, or an inadequate response for at least three weeks, defined as a plateau-phase on the MADRS.
- A minimum of 21 points on the MADRS at baseline.
- Age between 18 and 65 years, male and female.
- A period of at least 7 days (depending on the T½) free from antidepressants, antipsychotics, mood stabilizers.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In a pilot study with 15 patients, we want to evaluate the effectiveness and tolerability of metyrapone in depression, by administering metyrapone open label as addition to an antidepressant in patients with a DSM-IV-TR unipolar major depressive episode, who have not responded to at least one conventional antidepressant agent.;Primary end point(s): Score on MADRS at 5 weeks compared to baseline;Secondary Objective: The secondary aim of the pilot study is the assessment of the feasibility of conducting a randomized placebo controlled trial with metyrapone in depression.<br>In this randomized controlled trial, the aims would be assessment of potentiating effects of metyrapone during a standard antidepressant therapy, assessment of onset of action and overall and sustained treatment response (replication of the Jahn et al study, 23 in outpatients, with more extensive endocrine measures to assess hyperactivity of the HPA-axis, and analysis of depression subtypes).<br>