unipolar depressive episode without psychotic features according to DSM-IV-TR MedDRA version: 9.1 Level: LLT Classification code 10027515 Term: Metyrapone challenge test
Conditions
Interventions
Trade Name: Metopiron
Pharmaceutical Form: Capsule*
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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). | — |
Countries
Netherlands
Outcome results
None listed