EUCTR2020-005450-18-NL进行中（未招募）1 期
SPACe 2 STAR : Safety and pharmacokinetics of antipsychotics in children 2. Studying TDM in An RCT - SPACe 2 STAR
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age 6 to 18 years
- •ANDDocumented clinical diagnosis of autism spectrum disorder according to DSM IV or DSM V and comorbid behavioural problems
- •ANDTo start treatment with risperidone
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 140
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Diabetes type I or II
- •Congenital or acquired syndrome associated with changes in appetite, body weight or lipid profile (e.g. Prader Willi)
- •Treatment with antipsychotic medication within the last 6 months
- •Known Long QT syndrome (LQTS)
研究者
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