Optimal Duration of Olazapine Add-on therapy in Major Depression: A double-blind, placebo-controlled, randomized, Phase III, Pilot Study in parallel group Design - OLA-D

Charité Universitätsmedizin Berlin0 个研究点开始时间: 2007年8月15日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•-informed consent of patient
•-age 18 - 80 yrs.
•-diagnosis of major depression according to DSM-IV, unipolar course
•-Hamilton-Depression-Scale (17 item score) >18 prior to inclusion
•-response towards therapy with antidepressant and Olanzapine as defined by >50% reduction of HAM-D (17) score
•-negative pregnancy testing
•-highly effective contraceptive method in women (Pearl-index<1) or sexual abstinence during study period
•-no participation in any other trial according to German Pharmaceuticals Act (AMG)1month prior to and during study participation
•-normal liver function (SGOT, SGPT)(see exclusion criteria)
•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) yes
•F.1.3.1 Number of subjects for this age range

•-duration of current depressive episode > 1yr.
•-number of previous episodes > 5
•-pregnancy, lactation
•-depressive episode secondary to somatic disease or substance dependency
•-contraindication for Zyprexa substance or constituents
•-severe psychotic symptoms and/or hallucinations (PANSS positive scale: 4 or more on one of the following items: delusions P1, hallucinations P3, Delusions of persecution P6)
•-treatment with interacting substances (CYP1A2 inhibitors or inductors)
•-treatment with substances prolonging QTc period as listed in the protocol appendix
•-comorbidity according to DSM-IV, axis I
•-denial of consent to §12, §13 GCP-V (Germany)
•-hospital treatment by legal order
•-hepatic insufficiency, elevation of SGOT, SGPT, and/or GGT of more than 3fold upper reference value
•-severe neurological or medical disease
•-adipositas permagna (BMI>30)
•-HIV-infection
•-active viral hepatitis

发起方