Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- HDL Ratio
研究概览
简要总结
The objective of this study is to determine the effect of various mood stabilizers (MS) on the insulin resistance syndrome (IRS; also called the metabolic syndrome) alone and in patients treated with antipsychotic drugs (APDs). Patients will be switched from their current antipsychotic medication to aripiprazole (Abilify) or ziprasidone (Geodon) (unless clinically contraindicated) for comparison with metabolic levels during treatment with the former medication.
The metabolic syndrome is an empirical concept based on extensive evidence that a constellation of 5 metabolic abnormalities, e.g. increased cholesterol, hypertension, low HDL, taken together, predict marked increases in the risk of CVD, stroke and some types of cancer.
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: ziprasidone vs. aripiprazole (Drug)
1
aripiprazole (Abilify)
干预措施: aripiprazole vs. ziprasidone (Drug)
2
ziprasidone (Geodon)
干预措施: aripiprazole vs. ziprasidone (Drug)
结局指标
主要结局
HDL Ratio
时间窗: 24 weeks from Baseline
change in HDL ratio after medication switch
次要结局
未报告次要终点
研究者
Herbert Meltzer
Professor
Vanderbilt University
