Safety and pharmacokinetics of antipsychotics in children 2: Studying TDM in an RCT
Recruiting
- Conditions
- Autism Spectrum Disorder
- Registration Number
- NL-OMON23089
- Lead Sponsor
- Erasmus Medical Center Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 140
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in body mass index z-scores 6 months after start of treatment.
- Secondary Outcome Measures
Name Time Method 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.