Safety and pharmacokinetics of antipsychotics in children with autism
Completed
- Conditions
- Autism Spectrum Disorder (autisme spectrum stoornis)
- Registration Number
- NL-OMON22814
- Lead Sponsor
- Erasmus Medical Center Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
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
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)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method First, a pharmacokinetic (PK) model is built, linking dosage to drug plasma levels.<br /><br>Second, in the pharmacodynamic (PD) analysis we will investigate the relation between the pharmacokinetic model and weight change.
- Secondary Outcome Measures
Name Time Method In a second pharmacodynamic (PD) analysis we will investigate the relation between the pharmacokinetic model and cardiac<br>changes, extrapyramidal symptoms, metabolic abnormalities, somnolence and clinical effectiveness. <br /><br>We will also verify the relationship between DBS and venipuncture measurements of drug plasma levels in a small subgroup of children.