Safety and pharmacokinetics of antipsychotics in children 2: Studying TDM in an RCT

Main objective:
Our goal is to study the effectivity of therapeutic drug monitoring to prevent or mitigate side effects of risperidone use in children and adolescents. To this end we will study the differences in weight gain six months after start of treatment with risperidone between a group of children receiving therapeutic drug monitoring based dosing advice and a group of children receiving risperidone according to standard clinical care.

Secondary Objectives:
For our secondary objectives we will compare drug effectivity between the groups, based on
severity of irritability and aggression as measured by the Aberrant Behavior Checklist (ABC). The following secondary safety parameters will be compared between the groups: levels of glucose, cholesterol, lipoproteins and triglycerides; the hormones ghrelin, prolactin and leptin as well the level of extrapyramidal side effects as measured by the Abnormal Involuntary Movement Scale (AIMS).

We hypothesize that therapeutic drug monitoring of risperidone in children with an autism spectrum disorder and comorbid behavioral problems will reduce metabolic side effect burden, while retaining clinical effectiveness.

Start, 4 weeks, 10 weeks, 24 weeks

Therapeutic drug monitoring: dosing advice of risperidone based on measured blood concentration of risperidone and 9-OH-risperidone.