Exploring the Effect of Methylphenidate and Antidepressants on Cardiac Repolarisation.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- ECG changes
研究概览
简要总结
Studies have shown that the risk of developing heart arrhythmias, is increased in patients receiving medication for Attention-deficit hyperactivity disorder (ADHD) and depression. The QT-interval on a electrocardiogram (ECG) is often used to assess the patients risk of developing heart arrhythmias. The QT-interval defines the hearts electrical resting period and a long interval is linked to an increased risk of developing heart arrhythmias. In this project the investigators wish to examine possible side-effects in patients receiving medication for ADHD and depression and their dynamic QT-interval changes, by analysing the ECG changes that occur during "Brisk Standing".
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old
- •Patients treated with Methylphenidate
- •Patients treated with Methylphenidate and QT-prolonging SSRI
- •Patients treated with Methylphenidate and a non QT-prolonging SSRI
排除标准
- •Patients considered in an unstable phase in their psychiatric condition
- •Patients that are not able to understand the information regarding the trial, or who are unable to cooperate.
结局指标
主要结局
ECG changes
时间窗: Through study completion, an average of 1 year.
The Primary Outcome assess whether there are changes on ECG, primary the QTc-interval, in participants receiving medication for ADHD and depression.
次要结局
未报告次要终点
研究者
Peter Marstrand
MD research fellow (Ph.D)
Copenhagen University Hospital at Herlev