E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
unipolar depressive episode without psychotic features according to DSM-IV-TR |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027515 |
E.1.2 | Term | Metyrapone challenge test |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
The secondary aim of the pilot study is the assessment of the feasibility of conducting a randomized placebo controlled trial with metyrapone in depression. 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).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Score on MADRS at 5 weeks compared to baseline |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |