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

NCT05146245 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-12-08

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Therapeutic Drug Monitoring

Physician receives dosing advice based on risperidone plasma level.

OTHER

Risperidone plasma level

Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot.

Sponsors & Collaborators

  • Stichting de Merel

    collaborator UNKNOWN

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05146245 on ClinicalTrials.gov