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

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

Recruiting
6-18 years
All
Phase 4
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Overview

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

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

Study details
    Autism Spectrum Disorder

NCT05146245

Erasmus Medical Center

26 January 2024

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