CTIS2024-511568-96-00进行中（未招募）1 期
Safety and pharmacokinetics of antipsychotics in children 2: Studying TDM in an RCT - NL75882.078.20
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 64（—）
- 性别
- All
入选标准
- •? Age 6 to 18 years ? Documented clinical diagnosis of autism spectrum disorder according to DSM IV or DSM V and comorbid behavioural problems ? To start treatment with risperidone or aripiprazole
排除标准
- •? Diabetes type I or II ? Congenital or acquired syndrome associated with changes in appetite, body weight or lipid profile (e.g. Prader Willi) ? Known history of Long QT syndrome (LQTS), cardiovascular disorders (myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), seizure disorder or oesophageal dysmotility ? Pregnancy ? Hypersensitivity to the active substance or to any of the excipients
研究者
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