2024-511568-96-00招募中4 期
Safety and pharmacokinetics of antipsychotics in children 2: Studying TDM in an RCT
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)12 个研究点 分布在 2 个国家目标入组 280 人开始时间: 2024年7月16日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 12
- 主要终点
- Difference between the groups in change in body mass index z-scores (BMI-Z) after 6 months of treatment
研究概览
简要总结
Our goal is to study the effectivity of therapeutic drug monitoring to prevent or mitigate side-effects of risperidone and aripiprazole use in children and adolescents. To this end we will study the differences in weight gain six months after start of treatment with risperidone or aripiprazole between a group of children receiving therapeutic drug monitoring based dosing advice and a group of children receiving risperidone or aripiprazole according to standard clinical care.
研究设计
- 分配方式
- Randomized
- 主要目的
- Tdm Or Cau
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
Difference between the groups in change in body mass index z-scores (BMI-Z) after 6 months of treatment
Difference between the groups in change in body mass index z-scores (BMI-Z) after 6 months of treatment
次要结局
- Difference between the groups in change in body mass index z-scores (BMI-Z) after 12 months of treatment.
- Aberrant Behavior Checklist, a parental symptom checklist for assessing problem behaviour in children. The gold standard for measuring the effect of treatment on aggression and irritability in children with autism spectrum disorder
- EuroQol-5D Youth. A descriptive system for health-related quality of life states in five dimensions, plus a visual analogue scale.
- Pediatric Quality of Life Inventory. A modular instrument aimed at measuring healthrelated quality of life in children and adolescents. It showed excellent reliability and validity in individuals with autism spectrum disorder
- Clinical Global Improvement
- Treatment Inventory of Costs in Patients with psychiatric disorders. A modular questionnaire aimed at mapping healthcare utilization and the repercussions of psychosocial problems, allowing for the assessment of associated costs.
- Levels of glucose, cholesterol, lipoproteins and triglycerides; the hormones ghrelin, prolactin and leptin.
- Abnormal Involuntary Movement Scale, a clinician administered observational scale aimed at detecting extrapyramidal side effects.
- Blood pressure
研究者
Dr. B. Dierckx
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (12)
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