Fast Titration Of Quetiapine Versus Currently Approved Titration: A Randomised, Multicentre, Parallel Group Open Trial In Schizophrenia And Schizoaffective Disorder

AstraZeneca7 个研究点分布在 1 个国家目标入组 150 人开始时间: 2004年10月最近更新: 2011年1月26日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: AstraZeneca
入组人数: 150
试验地点: 7
主要终点: Proportion of patients with moderate and severe adverse events

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the safety and tolerability of a more rapid dose titration in acute schizophrenic patients compared to the conventional titration.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Signed informed consent, male or female between 18 and 60 years old, having acute exacerbation of their schizophrenia or schizoaffective disorder requiring admission to hospital. Should stay in hospital for at least 7 days.

排除标准

•Patients treated with Risperdal consta or Clozapine last 28 days, pregnancy or breast-feeding, patients known to be intolerant or unresponsive to quetiapine, known arrhythmia, other serious medical conditions.

结局指标

主要结局

Proportion of patients with moderate and severe adverse events

次要结局

Mean daily level of somnolence and orthostatic dizziness as rated on AE intensity scale

研究者

发起方

AstraZeneca

申办方类型

Industry

研究点 (7)

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