Testing drug monitoring of risperidone in children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Erasmus Medical Center
  Rotterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Birgit Koch
• Email: b.koch@erasmusmc.nl

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.