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 ).
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