A 6-Week, Multi-centre, Double-blind, Double-dummy, Chlorpromazine-Controlled Randomised Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Extended-Release in the Treatment of Schizophrenic Patients With Acute Episode
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of quetiapine fumarate extended-release (XR) used as mono-therapy, administered once daily, in the treatment of schizophrenic patient with acute episode.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Schizophrenia diagnosis
- •Provision of written informed consent before initiation of any study
排除标准
- •AIDS and hepatitis B
- •History of seizure disorder
- •Hospitalisation for schizophrenic more than 1 month immediately before enter into study
研究组 & 干预措施
1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) extended-release (300 mg/1st day, 600 mg/2nd day, 400 or 600 or 800 mg/3-42 day)
干预措施: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) (Drug)
2-Chlorpromazine
Chlorpromazine (50 or 100 mg/1st day; 100-200 mg/2nd day; 150-300 mg/3rd day; 200-400 mg/4th day; 300 or 400 or 500 or 600 mg/5-42 days)
干预措施: Chlorpromazine (Drug)
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 at Day 42
时间窗: Baseline and 6 weeks
6 weeks minus baseline.PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. Total scores range 30-210 from better to worse.
次要结局
- Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42(Baseline and 6 weeks)
- Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42(Baseline and 6 weeks)
- Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42(Baseline and 6 weeks)
- Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42(Baseline and 6 weeks)
- Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42(Baseline and 6 weeks)
- Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42(Baseline and 6 weeks)
- Percentage of Patients With Clinical Global Impression (CGI) Global Improvement Rating Less Than or Equal to 3 at the End of Treatment at Day 42(Baseline and 6 weeks)
- Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42(Baseline and 6 weeks)