NCT00328978已完成3 期
A Canadian, Multicenter, Double-Blind, Randomized, Parallel-Group Study of the Safety, Tolerability, and Efficacy of Treatment With Higher Doses of Quetiapine Fumarate (Seroquel®) Greater Than 800 mg/Day in Schizophrenic or Schizoaffective Subjects.
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
- 330
- 试验地点
- 17
- 主要终点
- To determine the proportion of subjects (%) experiencing emergent or a worsening of EPS following treatment of quetiapine 800mg or higher than 800 mg/day in schizophrenic or schizoaffective subjects.
研究概览
简要总结
The purpose of the study is to assess and compare the side effect profile, safety, tolerability and efficacy of schizophrenic or schizoaffective subjects non- or partially- responsive to 800 mg/day of quetiapine treated with either 800 mg/day or more than 800 mg/day of quetiapine during 8 weeks.
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
- •Inclusion Criteria: Men and women, age 18-65 years with persistent positive or negative symptoms with a PANSS total score of ≥ 70 and < 110 and a Clinical Global Improvement (CGI)- Severity of Illness score of at least 4 (moderately ill) at screening. Subjects may be treated as in- or out-patients. Subjects must give written informed consent.
排除标准
- •Subjects with other psychiatric, medical or behavioural comorbid disorder that may interfere with study conduct or interpretation.
- •Female of childbearing potential, unless the subject is using a reliable method of contraception
- •Subjects with alcohol or psychoactive-substance dependence not in full remission or with significant alcohol or substance abuse in the past 3 months will be excluded.
- •Laboratory test results outside the range of reference considered by the investigator to be clinically significant.
- •Inability to respect the visit schedule and known intolerance to quetiapine at 800mg/day.
结局指标
主要结局
To determine the proportion of subjects (%) experiencing emergent or a worsening of EPS following treatment of quetiapine 800mg or higher than 800 mg/day in schizophrenic or schizoaffective subjects.
次要结局
- To determine the safety, tolerability and efficacy of treatment with quetiapine in with doses higher than 800 mg/day in schizophrenic or schizoaffective subjects.
研究者
研究点 (17)
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