Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
Who is this study for? Children with autism spectrum disorder and comorbid behavioral problems
What treatments are being studied? Therapeutic Drug Monitoring+Risperidone plasma level
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The aim of this study is to test whether therapeutic drug monitoring of risperidone in children with autism spectrum disorder and comorbid behavioral problems is able to reduce metabolic side effect burden, while retaining clinical effectiveness.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Netherlands
Erasmus Medical Center
RECRUITING
Rotterdam
Contact Information
Primary
Birgit Koch
b.koch@erasmusmc.nl
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2024-05
Participants
Target number of participants: 140
Treatments
Experimental: Therapeutic Drug Monitoring
Physicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone.
Active_comparator: Care As Usual
Physician decides on possible dosing changes without receiving advice based on blood levels.
Related Therapeutic Areas
Sponsors
Collaborators: Stichting de Merel, ZonMw: The Netherlands Organisation for Health Research and Development
Leads: Erasmus Medical Center