Randomized Olanzapine Clozapine Key study on Schizophrenia and Addiction in the Netherlands (ROCKSAN) - ROCKSA

Academisch Medisch Centrum0 个研究点目标入组 140 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Eligible for the study are in- and outpatients age 18 to 50, meeting DSM-IV criteria for schizophrenia, schizoaffective - or schizophreniform disorder and substance abuse or dependence based on the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID-P).
•Patients that are admitted under authority of the court should also be included, since this group embodies a very large percentage of the targetgroup.
•Patients should be able to understand the study information and procedures and give informed consent.

•- Pregnancy
•- Lactating women
•- Female subject without adequate contraception
•- Known hypersensitivity to clozapine, olanzapine or ingredients used in these tablets
•- Concomitant daily use of any antipsychotic other drug than clozapine or olanzapine (crisis intervention medication excepted)
•- Use of depot antipsychotics in the three months prior to inclusion
•- Narrow-angle glaucoma
•- Known neurological or endocrine disease interfering with clozapine or olanzapine treatment
•- Myeloproliferative disorder
•- Uncontrolled epilepsy
•- History of treatment with clozapine in the past 12 months during at least 4 months at therapeutic serum levels
•- Paralytic ileus
•- Current leukocyte level lower than 3.5 x 10 9/l
•- Current neutrophilic granulocyte level lower than 2.0x 10 9/l

发起方