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临床试验/JPRN-UMIN000007145
JPRN-UMIN000007145已完成未知

Psychiatric emergency multi-center randomized clinical trial on unanswered questions of pharmacotherapy in acute-phase schizophrenia - Psychiatric emergency multi-center RCT of antipsychotic switching and augmentation to early non-responders

Juntendo University Faculty of Medicine0 个研究点目标入组 200 人开始时间: 2012年4月30日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
200

研究概览

简要总结

Results: Sixty patients who completed 2 weeks of risperidone treatment were divided into 33 early responders (RIS-ER) and 27 ENRs (RIS+OLZ, n=14; RIS-OLZ, n=13). Although time to treatment discontinuation for any cause was significantly shorter in RIS+OLZ group (54.1 days [95% confidence interval, 41.3-67.0]) than in RIS-ER group (68.7 [61.2-76.2]; P=0.050), it was not significantly shorter in RIS-OLZ group (58.5 [43.1-73.9]) than in RIS-ER group (P=0.19). Sixty patients who completed 2 weeks of olanzapine treatment were divided into 36 early responders (OLZ-ER) and 24 ENRs (OLZ+RIS, n=11; OLZ-RIS, n=13). Although time to treatment discontinuation for any cause was significantly shorter in OLZ-RIS group (56.1 days [40.7-71.5]) than in OLZ-ER group (74.9 [68.5-81.3]; P=0.008), it was not significantly shorter in OLZ+RIS group (64.6 [49.6-79.6]) than in OLZ-ER group (P=0.20). Conclusion: Despite the lack of pharmacokinetic investigation of dose adequacy in this study, it is possible that switching to olanzapine among ENRs to risperidone might have a small advantage over augmentation with olanzapine, while augmentation with risperidone might have a small advantage over switching to risperidone among ENRs to olanzapine. Further research is required before it would be appropriate to modify routine practice in the direction of these findings.

研究设计

研究类型
Interventional

入排标准

年龄范围
18years-old 至 65years-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1) severe liver, renal, heart, or respiratory dysfunction 2) diabetes mellitus, or its history 3) pregnant, nursing, or desiring to be pregnant

研究者

发起方
Juntendo University Faculty of Medicine

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