NL-OMON56377招募中4 期
SPACe 2 STAR : Safety and pharmacokinetics of antipsychotics in children 2. Studying TDM in An RCT - SPACe 2 STAR
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
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
- 2 至 17（—）
入选标准
- •Age 6 to 18 years
- •AND Documented clinical diagnosis of autism spectrum disorder according to DSM
- •IV or DSM V and comorbid behavioural problems
- •AND To start treatment with either 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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