Mirtazapine Reduces ICD Appropriate Shocks in Cardioverter Implanted Patients With Depression and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- number of implantable cardioverter defibrillator shocks
研究概览
简要总结
The purpose of this study is to evaluate if the use of antidepressant medication in depressed patients with implantable cardioverter defibrillator reduces the number of ICD's shocks as it improves depressive affect.
详细描述
episodes of arrhythmia remain present even after icd implantation, this is specially true in depressed patients. it is hypothesized that improving mood state by means of an antidepressant drug . namely mirtazapine. could be responsible of alleviating the number of appropriate shocks delivered by the cardioverter. this could be due to a direct effect of the drug itself or an indirect effect of improving anxious and depressive affect. the mood and anxiety state are measured with the HADS scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 87 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cardioverter implanted patients
- •depression
排除标准
- •heart failure
- •other diseases reducing physical fitness
研究组 & 干预措施
mirtazapine
干预措施: mirtazapine (Drug)
mirtazapine, sugar pill
干预措施: mirtazapine (Drug)
结局指标
主要结局
number of implantable cardioverter defibrillator shocks
时间窗: one year
次要结局
- improvement of depression(one year)