NCT00085891已完成3 期
A 6-Week, Multicenter, Double-Blind, Double-Dummy, Randomized Comparison of the Efficacy and Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Acutely Ill Patients With Schizophrenia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 535
- 试验地点
- 29
- 主要终点
- Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment.
研究概览
简要总结
The purpose of this study is to demonstrate superior efficacy of sustained release quetiapine compared to placebo in patients with schizophrenia after receiving treatment for up to 6 weeks.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is able to provide written informed consent before beginning any study related procedures
- •Patient has a documented clinical diagnosis of schizophrenia
- •Patient is able to understand and comply with the requirements of the study, as judged by a study investigator
排除标准
- •Patients with a history of non-compliance as judged by the study investigator
- •Patients with a known lack of response to previous treatment with quetiapine
- •Patients who have participated in another drug study within 4 weeks prior to enrollment into this study
- •Patients who have previously participated in this study or study D1444C00132
结局指标
主要结局
Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment.
次要结局
- Evaluation of secondary PANSS efficacy variables and Clinical Global Impression (CGI) variables at all study visits compared to baseline.
研究者
研究点 (29)
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