Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
试验速览
- 阶段
- 4 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- BMI z-score
研究概览
简要总结
The aim of this study is to test whether therapeutic drug monitoring of risperidone in children with autism spectrum disorder and comorbid behavioral problems is able to reduce metabolic side effect burden, while retaining clinical effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
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)
- •Treatment with antipsychotic medication within the last 6 months
- •Known Long QT syndrome (LQTS)
- •Pregnancy
研究组 & 干预措施
Therapeutic Drug Monitoring
Physicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone.
干预措施: Therapeutic Drug Monitoring (Other)
Therapeutic Drug Monitoring
Physicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone.
干预措施: Risperidone plasma level (Other)
Care As Usual
Physician decides on possible dosing changes without receiving advice based on blood levels.
干预措施: Risperidone plasma level (Other)
结局指标
主要结局
BMI z-score
时间窗: 6 months
Difference in body mass index z-scores 6 months after start of treatment.
次要结局
- Endocrine side effects (leptin)(6 months)
- Metabolic side effects (triglycerides)(6 months)
- Metabolic side effects (glucose)(6 months)
- Endocrine side effects (prolactin)(6 months)
- Endocrine side effects (ghrelin)(6 months)
- Metabolic side effects (cholesterol)(6 months)
- Extrapyramidal symptoms (EPS)(6 months)
- Effectivity (ABC)(6 months)
- Effectivity (CGI)(6 months)
- Quality of Life (PedsQL)(6 months)
- Side effects (blood pressure)(6 months)
研究者
Birgit Koch
Prof.Dr.
Erasmus Medical Center