UnknownPhase 4

Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT

Netherlands140 participantsStarted 2021-12-01

Plain-language 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.

Who can participate

Age range6 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

BMI z-score

Timeframe: 6 months

Trial details

NCT IDNCT05146245

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05

Contact for this trial

Birgit Koch

b.koch@erasmusmc.nl

View on ClinicalTrials.gov More Autism Spectrum Disorder trials