NL-OMON23089
Recruiting
Not Applicable
Safety and pharmacokinetics of antipsychotics in children 2: Studying TDM in an RCT
Erasmus Medical Center Rotterdam0 sites140 target enrollmentTBD
ConditionsAutism Spectrum Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Erasmus Medical Center Rotterdam
- Enrollment
- 140
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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)
Outcomes
Primary Outcomes
Not specified
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