autism
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 99 Years
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 -Treated with either aripiprazole, risperidone or pipamperone
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 another antipsychotic within the last 6 months - Known Long QT syndrome (LQTS)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First, a pharmacokinetic (PK) model is built, linking dosage to drug plasma levels. Second, in the pharmacodynamic (PD) analysis we will investigate the relation between the pharmacokinetic model and weight change. | — |
Secondary
| Measure | Time frame |
|---|---|
| In a second pharmacodynamic (PD) analysis we will investigate the relation between the pharmacokinetic model and cardiac changes, extrapyramidal symptoms, metabolic abnormalities, somnolence and clinical effectiveness. We will also verify the relationship between DBS and venipuncture measurements of drug plasma levels in a small subgroup of children. | — |
Countries
Netherlands
Outcome results
None listed