NCT05146245RecruitingPhase 4
Safety and pharmacokinetics of antipsychotics in children 2: Studying TDM in an RCT
Source: EU CTIS (euclinicaltrials.eu) · Last updated 31 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 20 Jun 2024
- Start date
- 16 Jul 2024
- Lead sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Diseases
- Autism
- NCT number
- NCT05146245
- EU CT number
- 2024-511568-96-00
- EudraCT number
- 2020-005450-18
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 280
- 12 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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
Who the study is looking for
- 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
Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tübingen University Hospital Coordinator of this site? Confirm its status | Tübingen | Germany | Completed |
| Wurzburg University Hospital Coordinator of this site? Confirm its status | Wuerzburg | Germany | Completed |
| KJP Mariaberg Coordinator of this site? Confirm its status | Gammertingen | Netherlands | Recruiting |
| Erasmus MC Coordinator of this site? Confirm its status | - | Netherlands | Recruiting |
| Yulius GGZ Coordinator of this site? Confirm its status | - | Netherlands | Recruiting |
| Accare Coordinator of this site? Confirm its status | - | Netherlands | Recruiting |
| GGZ Delfland Coordinator of this site? Confirm its status | - | Netherlands | Recruiting |
| GGz Breburg Coordinator of this site? Confirm its status | - | Netherlands | Recruiting |
| Mondriaan Coordinator of this site? Confirm its status | - | Netherlands | Recruiting |
| 's Heeren Loo Coordinator of this site? Confirm its status | - | Netherlands | Recruiting |
| LUMC Curium Coordinator of this site? Confirm its status | - | Netherlands | Recruiting |
| Karakter Coordinator of this site? Confirm its status | - | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.