CTRI/2017/11/010391已完成不适用
Early response to antipsychotics as a predictor to later response in non affective psychosis
Goverment Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Identify the early responder and non responder
研究概览
简要总结
Present Study is planned to see Whether Early response to Anti-psychotics is a predictor to later reponse to Antipsychotics in Non Affective Psychosis.Two Antipsychotics were used.
Response will be seen in this follow up study of 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient should meet the following psychopathology severity criteria at the time of inclusion into the study 1.total score extracted from Positive and Negative Syndrome Scale should be atleast 45
- •A score of atleast 4 [moderate] on at least 2 of following BPRS items: conceptual disorganization, suspiciousness, hallucinatory behavior and unusual thought content 3.Patient who are either drug naïve or who had relapsed in preceding 2 weeks requiring change in medications.
排除标准
- •1.Patient with history of inadequate response to risperidone or olanzapine in the past.
- •2.Patient with history of allergic reaction to risperidone or olanzpine 3.History of use of risperidone or olanzapine with in past 30 days before the study enrolment.
- •4.Acute, serious or unstable co-morbid medical condition 5.Schizo-affective disorder 6.Active substance dependence except nicotine and caffeine 7.Pregnant and lactating women 8.Treatment resistant schizophrenia.
结局指标
主要结局
1.Identify the early responder and non responder
时间窗: 1t week,2nd week,4th week,6th week,8th week.
2.the response rate amongst the early non-responders after either continuing on the same antipsychotic or being switched over to another atypical antipsychotic
时间窗: 1t week,2nd week,4th week,6th week,8th week.
次要结局
- 20% Reduction in the illness severity on PANSS.(2nd week)
研究者
研究点 (1)
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