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临床试验/CTRI/2016/02/006660
CTRI/2016/02/006660已完成4 期

Comparative Efficacy and Tolerability of Quetiapine and Clozapine in Treatment Resistant Schizophrenia (TRS)

Mitesh Kumar0 个研究点目标入组 40 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
40

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

入选标准

  • 1)Patients suffering from schizophrenia as per ICD 10 (Diagnostic Criteria for Research ) criteria and fulfilling modified version of Conley and Kellyâ??s criteria of Treatment Resistant Schizophrenia(TRS) which is defined as:
  • a) No clinical response with two different antipsychotics used separately in the dose range of 400â??600 mg of chlorpromazine per day or equivalents for 6 weeks,
  • b) no period of good social or occupational functioning at least in last one year, plus a minimum Clinical Global Impressions (CGI) Scale rating of 4 (moderately ill),
  • c)BPRS total score > 45, and a score of >4 on 2 of 4 positive items.
  • 2) Patients who are accompanied by reliable informants.
  • 3) Patients and relatives willing to give informed consent

排除标准

  • 1) Patients of co-morbid substance dependence except nicotine use.
  • 2) Patients who have received clozapine or quetiapine in the past.
  • 3) Patients with sub normal intelligence.
  • 4) Patient with heart conduction defects, history of agranulocytosis or TLC less than 3500 per mm3
  • and pre-existing diabetes mellitus, hypertension.
  • 5) Patient with neurological disorders such as head injury, epilepsy, movement disorder and tumours.
  • 6) Pregnant and lactating mother.
  • 7) Patient with late onset schizophrenia ( after 45 years ).

研究者

发起方
Mitesh Kumar

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