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

eiden University Medical Center0 个研究点开始时间: 2007年3月2日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- 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

•- 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.

发起方

eiden University Medical Center