Autism Spectrum Disorder
Conditions
Interventions
Therapeutic drug monitoring: dosing advice of risperidone based on measured blood concentration of risperidone and 9-OH-risperidone.
Sponsors
Erasmus Medical Center Rotterdam
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in body mass index z-scores 6 months after start of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactRebecca Hermans
Erasmus MC
Outcome results
None listed