NCT00206115已完成3 期
A 6-week, Multicenter, Double-blind, Double-dummy, Randomized Comparison of the Efficacy & Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia
适应症
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
- 535
- 试验地点
- 30
- 主要终点
- The primary outcome variable will be the 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 purpose of this 6-week study is to determine whether treatment with Seroquel® Sustained Release (SR) is more effective than placebo in the treatment of acute schizophrenia.
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
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •To be considered for this study the patients should be aged between 18 to 65 years, need to suffer from schizophrenia and must be willing to participate.
排除标准
- •Patients that suffer from psychiatric disorders other than schizophrenia including drug abuse and dependence, or medical conditions such as specific kidney, heart or thyroid problems, and patients with a known lack of response to drugs for schizophrenia will not be considered for this study.
结局指标
主要结局
The primary outcome variable will be the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment at Day 42.
次要结局
- Efficacy
- To demonstrate a higher PANSS response rate
- To demonstrate superior Clinical Global Impressions (CGI) response
研究者
研究点 (30)
Loading locations...
相似试验
已完成
4 期
A Study to Evaluate the Efficacy and Safety of Seroquel in Chinese Han Patients With SchizophreniaSchizophreniaNCT00817648Shanghai Mental Health Center120
已完成
3 期
Generalized Anxiety Disorder Adjunct StudyAnxiety NeurosesAnxiety StatesAnxiety DisordersAnxietyNCT00534599AstraZeneca409
已完成
3 期
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive DisorderMajor Depressive DisorderNCT00320268AstraZeneca600
已完成
3 期
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo and Active Control in Major Depressive DisorderMajor Depressive DisorderNCT00321490AstraZeneca600
已完成
3 期
Efficacy & Safety of Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With SchizophreniaSchizophreniaNCT00085891AstraZeneca535