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临床试验/NL-OMON32193
NL-OMON32193尚未招募3 期

Effect of different antipsychotic medications on craving and craving related brain activity in patients with schizophrenia and cannabis abuse or dependence: a randomized controlled study comparing clozapine and risperidone - fmri.clo.ris.can

Academisch Medisch Centrum0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
入组人数
70

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Eligible for the study are male in- and outpatients age 18 to 30 (extremes included), of diverse ethnicity, meeting DSM-IV criteria for schizophrenia, schizoaffective - or schizophreniform disorder and cannabis abuse or dependence based on the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID-P). Women will not be included because co-morbid cannabis abuse or dependence occurs more frequent in men and the expected number of included subjects, therefore, would not allow separate analysis.
  • We will also include schizophrenia patients without cannabis abuse or dependence and compare their outcomes with those of patients with co-occurring cannabis abuse or dependence.
  • A group of healthy, matched controls will be included to get information on brain activation patterns associated with specific cognitive tasks in antipsychotic-naïve healthy controls. These controls are included to make a comparison with patients with schizophrenia who have been treated with antipsychotics for 4 weeks.
  • All patients need to be abstinent for cannabis use minimally three days before assessment of functional craving pathways

排除标准

  • Exclusion criteria are
  • (1) known hypersensitivity to any ingredient of clozapine or risperidone,
  • (2) concomitant use of any antipsychotic drug other than clozapine or risperidone,
  • (3) use of depot antipsychotics in the three months prior to inclusion,
  • (4) use of psychotropic medications other than oxazepam or biperiden,
  • (5) narrow angle glaucoma,
  • (6) known neurological or endocrine disease,
  • (7) presence of non-removable metal objects
  • (8) myeloproliferative disorders,
  • (9) unstable epilepsy,
  • (10) agranulocytosis or leucopenia in the past
  • (11) Current leukocyte level is lower than 3.5 x 109/l, current
  • neutrophilic granulocyte level is lower than 2.0x 109/l

研究者

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