NCT00457899终止3 期
RAPID-An Open-Label Randomized, Multicenter Phase IIIb Study to Evaluate the Efficacy and Tolerability of Quetiapine IR (Immediate Release), Over 14 Days, in Acute Schizophrenia/Schizoaffective Disorder (Rapid Versus Conventional Titration)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 234
- 试验地点
- 12
- 主要终点
- The primary outcome variable of this study is change from baseline in total PANSS score
研究概览
简要总结
The purpose of this study is to determine whether increasing the amount (dose) of quetiapine IR (immediate release formulation) more rapidly than conventional dose increases, improves the control of symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) - a psychiatric assessment scale that measures both positive and negative symptoms - in patients with acute schizophrenia or schizoaffective disorder.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, aged 18 to 65 years, who require treatment for an acute episode of schizophrenia/schizoaffective disorder as judged by their doctor
排除标准
- •Significant and unstable conditions of hear, circulation, blood, liver, kidney; malignancies (cancer); diabetes (mellitus); history of fits or fainting. Resistance to antipsychotic medication. Current alcohol/drug abuse. Pregnant/breast feeding women.
结局指标
主要结局
The primary outcome variable of this study is change from baseline in total PANSS score
时间窗: at Day 7
次要结局
- frequency and severity of adverse events; change in vital signs.(assessed at each visit)
- Change from baseline in total PANSS scores(on day 5 and 14)
- change from baseline in subscale PANSS and PANSS-EC scores(on days 5, 7 and 14)
- change from baseline in CGI-S and absolute CGI-I(on days 5, 7 and 14)
研究者
研究点 (12)
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