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临床试验/EUCTR2008-003623-23-NL
EUCTR2008-003623-23-NL进行中(未招募)不适用

Effect of different antipsychotic medication on craving related brain activity in patients with schizophrenia and cannabis abuse or dependence:a randomized controlled study comparing clozapine and risperidone. - fMRI.Clozapine.Risperidon.Cannabis

Academisch medisch centrum, department of psychiatry0 个研究点开始时间: 2008年8月29日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

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.
  • We will also include healthy controls for 1 fMRI scan only.
  • All patients need to be abstinent for cannabis use minimally three days before assessment of functional craving pathways.
  • Each patient must understand the nature of the study and must sign an informed consent document.
  • 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

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 lower than 3.5 x 109/l, current
  • neutrophilic granulocyte level lower than 2.0x 109/l .

研究者

发起方
Academisch medisch centrum, department of psychiatry

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