Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid Measures and Ischemic Electrocardiographic Changes
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Triglyceride/High-density Lipoprotein (TG/HDL) Ratio
研究概览
简要总结
The primary goal of this study is to examine the triglyceride/high-density lipoprotein (TG/HDL) ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder.
详细描述
The primary goal of this study is to examine the triglyceride/high-density lipoprotein (TG/HDL) ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder. The secondary goal is to identify those subjects in the top tertile for the highest risk of ischemic heart disease (IHD) as defined by TG/HDL ratios (>>3.5) and ischemic EKG changes with and without clinical ischemia, e.g. angina and to see if these risk factors can be reduced or reversed by a change of antipsychotic medication, dietary counseling, enrollment into available exercise groups, etc.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
aripiprazole (Abilify)
干预措施: aripiprazole (Abilify) (Drug)
2
ziprasidone (Geodon)
干预措施: ziprasidone (Geodon) (Drug)
结局指标
主要结局
Triglyceride/High-density Lipoprotein (TG/HDL) Ratio
时间窗: 24 weeks
次要结局
- Weight(24 weeks)
- Cholesterol(24 weeks)
- High-Density Lipoprotein (HDL)(24 weeks)
- Body Mass Index (BMI)(24 weeks)
- Triglyceride (TG)(24 weeks)