NCT00621647已完成3 期
A Multicenter, Double-Blind, Randomized, Comparison of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Agitation Associated With Dementia.
适应症
干预措施
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
- 333
- 主要终点
- To assess the efficacy of 2 fixed doses of quetiapine compared with placebo
研究概览
简要总结
The purpose of this study is to determine how safe and effective Seroquel (quetiapine fumarate) is compared to placebo (a non-drug tablet) for a period of up to 10 weeks in the treatment of agitation symptoms in nursing home or assisted care residents.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a diagnosis of dementia compatible with probable or possible Alzheimer's disease (AD)
- •Subjects exhibit inappropriate verbal, vocal, or motor activity that requires treatment with an antipsychotic medication in addition to or beyond behavioural modification therapy
- •Subject must have a score of at least 14 on the PANSS
排除标准
- •Current or past symptoms for schizophrenia, schizoaffective disorder, or bipolar disorder
- •Symptoms of agitation that are caused by another general medical condition or direct physiological effects of a substance
- •Failure to respond on 2 occasions to an adequate regimen of atypical antipsychotic medications for the treatment of agitation and/or aggression
研究组 & 干预措施
1
Experimental
1st fixed dose
干预措施: Quetiapine Fumarate (Drug)
2
Experimental
2nd fixed dose
干预措施: Quetiapine Fumarate (Drug)
3
Sham Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the efficacy of 2 fixed doses of quetiapine compared with placebo
时间窗: Twice weekly
次要结局
- To assess the efficacy of quetiapine compared with placebo(Twice weekly)
研究者
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