Testing drug monitoring of risperidone in children with autism
Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
This study is testing how to safely monitor and adjust the medication risperidone for children with autism to help manage their behavior while minimizing side effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT05146245 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and pharmacokinetics of risperidone in children aged 6 to 18 years diagnosed with autism spectrum disorder and behavioral problems. It focuses on the use of therapeutic drug monitoring to manage the medication's dosage effectively, potentially reducing metabolic side effects while maintaining its clinical effectiveness. The study will involve monitoring plasma levels of risperidone to tailor treatment for individual patients. Participants will be recruited from the Erasmus Medical Center in Rotterdam.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 18 years with a clinical diagnosis of autism spectrum disorder and comorbid behavioral issues who are starting treatment with risperidone.
Not a fit: Patients with diabetes, certain congenital syndromes, or those who have recently been treated with antipsychotic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective treatment options for children with autism spectrum disorder.
How similar studies have performed: Other studies have shown promise in using therapeutic drug monitoring for antipsychotics, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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) * Pregnancy
Where this trial is running
Rotterdam
- Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Birgit Koch
- Email: b.koch@erasmusmc.nl
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.