NCT00486798终止3 期
FAST-A Study to Evaluate the Efficacy and Safety of Quetiapin IR in Patients With Acute Psychosis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 试验地点
- 13
- 主要终点
- Assessment of Positive and Negative Syndrome Scale-Excitatory Subscale (PANSS-EC) at day 5 compared with baseline at day 1
研究概览
简要总结
The purpose of this study is to compare the efficacy of quetiapine IR, following rapid titration versus conventional titration in patients with acute psychosis
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
- •provision of written informed consent
- •male or female, aged 18-65 years
- •requirement of hospitalization and in need for antipsychotic treatment for an acute psychotic episode
- •able to swallow tablets from Day 1
排除标准
- •In-patients who are anticipated to be discharged before evaluation of the primary outcome variable at Day 5
- •patients with known relevant clinical disease
- •history of syncope, or orthostatic hypotension
- •patients with known neutropenia
结局指标
主要结局
Assessment of Positive and Negative Syndrome Scale-Excitatory Subscale (PANSS-EC) at day 5 compared with baseline at day 1
次要结局
- Assessment of PANSS-EC at Day 3 and 8. Clinical Global Impression (CGI) at baseline and at Day 5 and 8. FAST (For Acute Seroquel Therapy) rating scale at baseline and at Day 5 and 8. The sleeping pattern (8days). Withdrawals/treatment failures. AE
研究者
研究点 (13)
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