NCT00214578已完成4 期
Seroquel on Glucose Metabolism
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
- 572
- 试验地点
- 65
- 主要终点
- To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients
研究概览
简要总结
The purpose of this study is to determine whether six months treatment with the antipsychotic medicine Seroquel (quetiapine) may affect the schizophrenic patient's glucose metabolism
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
- •In- or outpatients with schizophrenia, 18-65 years old, requiring a change in treatment due to insufficient efficacy or tolerability and giving signed informed consent.
排除标准
- •Known diabetes mellitus, high HbA1c, fasting plasma glucose and/or high 2h glucose-OGTT.
- •Previous use of atypicals (3 months) or other medications that might influence glucose metabolism
- •Contraindications or non-responsiveness for any of the treatments or other safety issues
- •Expected non-compliance to treatment and/or study procedures
结局指标
主要结局
To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients
次要结局
- Glucose metabolism, blood lipid levels and weight
研究者
研究点 (65)
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