Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Changes in QT interval
研究概览
简要总结
Electrocardiogram (ECG) Q-T prolongation is a cardiac electrophysiological disorder associated with the occurrence of arrhythmias potentially fatal. Several psychotropic drugs are associated with an increased risk of QT prolongation, which is why in clinical practice a baseline ECG is performed before a psychotropic drug is prescribed. However, there are no validated protocols establishing when to repeat this examination or describing clinical events when this examination should be repeated in clinical follow-up.
The study aims to investigate the incidence of QTc prolongation events as a side effect of chronic psychotropic drug administration. For this purpose, ECGs will be recorded and confounding factors of patients at the beginning of psychotropic therapy and after 3, 6 and 12 months will be analyzed.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to psychiatry ward
- •Starting a psychotropic drug acting on QT interval
排除标准
- •Age >18aa
- •History of administration of drug acting on QT interval in the 3 months prior
研究组 & 干预措施
Monotherapy
Patients taking only one drug acting on QT interval
Monotherapy to monotherapy
Patients who have switched from a drug acting on QT interval to another
Polytherapy
Patients taking more than one drug acting on QT interval
结局指标
主要结局
Changes in QT interval
时间窗: Baseline, 1, 3, 6, 12, 18 months post- enrollment
次要结局
- Number of Cardiac events(Baseline, 1, 3, 6, 12, 18 months post- enrollment)