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ID
Source
Brief title
Health condition
Autism Spectrum Disorder
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in body mass index z-scores 6 months after start of treatment.
Secondary outcome
Effectivity, measured using the Aberrant Behavior Checklist (ABC). Secondary safety parameters: Levels of glucose, cholesterol, lipoproteins and triglycerides; the hormones ghrelin, prolactin and leptin. Abnormal Involuntary Movement Scale (AIMS), a clinician administered observational scale aimed at detecting extrapyramidal side effects.
Background summary
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).
Study objective
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.
Study design
Start, 4 weeks, 10 weeks, 24 weeks
Intervention
Therapeutic drug monitoring: dosing advice of risperidone based on measured blood concentration of risperidone and 9-OH-risperidone.
Inclusion criteria
• 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
Exclusion criteria
• 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9824 |
| Other | METC Erasmus MC : MEC-2021-0278 |