Testing drug level monitoring for risperidone or aripiprazole in autism spectrum disorder
Tests whether drug level checks ease side-effects of risperidone or aripiprazole in autism.
Plain-language title generated from the registry record
Registry title: Safety and pharmacokinetics of antipsychotics in children 2: Studying TDM in an RCT
Key facts
- Where
- Tübingen and Wuerzburg, GermanySee the 2 sites
- Phase
- Phase 4
Where in Germany
- Tübingen University HospitalTübingen, GermanyNo longer taking part
- Wurzburg University HospitalWuerzburg, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Trial code
- NCT05146245EU 2024-511568-96-00
- Record updated
- 31 July 2024
- Original description
Our goal is to study the effectivity of therapeutic drug monitoring to prevent or mitigate side-effects of risperidone and aripiprazole use in children and adolescents. To this end we will study the differences in weight gain six months after start of treatment with risperidone or aripiprazole between a group of children receiving therapeutic drug monitoring based dosing advice and a group of children receiving risperidone or aripiprazole according to standard clinical care.Read full original descriptionShow less
Safety and pharmacokinetics of antipsychotics in children 2: Studying TDM in an RCT
Our goal is to study the effectivity of therapeutic drug monitoring to prevent or mitigate side-effects of risperidone and aripiprazole use in children and adolescents. To this end we will study the differences in weight gain six months after start of treatment with risperidone or aripiprazole between a group of children receiving therapeutic drug monitoring based dosing advice and a group of children receiving risperidone or aripiprazole according to standard clinical care.
Inclusion: 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 or aripiprazole.
Exclusion: Diabetes type I or II Congenital or acquired syndrome associated with changes in appetite, body weight or lipid profile (e.g. Prader Willi) Known history of Long QT syndrome (LQTS), cardiovascular disorders (myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), seizure disorder or oesophageal dysmotility Pregnancy Hypersensitivity to the active substance or to any of the excipients.