NCT00428350已完成4 期
A 24-Week, Multi-Centre, Open-Label, Single-Arm, Phase IV Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) With Daily Dose 600mg-750mg as Mono-Therapy in the Treatment of Acute Schizophrenic Patients
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 120
- 试验地点
- 9
- 主要终点
- Change from baseline in PANSS total score at Day 56 (LOCF)
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of quetiapine fumarate (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline in PANSS total score at Day 56 using the last observation carried forward (LOCF) method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Provision of written informed consent for study participation before initiation of any study related procedures, signed by the patient's legal guardian
- •Female and/or male, aged between 18 and 60 years (inclusive)
- •Is hospitalised in a psychiatric unit with an acute episode of schizophrenia defined by CCMD-3 criteria as one of the following: [20.1] paranoid schizophrenia, [20.2] hebephrenic schizophrenia, [20.3] catatonic schizophrenia, [20.5] undifferentiated schizophrenia
排除标准
- •CCMD-3 diagnosis of mental retardation
- •Psychosis judged to be the direct physiological effect of an abused medication or substance
结局指标
主要结局
Change from baseline in PANSS total score at Day 56 (LOCF)
次要结局
- Change from baseline in PANSS positive scale score at Day 56 (LOCF)
- Change from baseline in PANSS negative scale score at Day 56 (LOCF)
- Change from baseline in PANSS EC score at day 56 ,
- Change from baseline in MADRS total score at Day 56. etc
研究者
研究点 (9)
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