Therapeutic drug monitoring in children and adolescents treated with quetiapine for different psychiatric disorders: results of the TDM-VIGIL pharmacovigilance study.

Authors

Alina Kaiser, Karin Maria Egberts, Hans-Willi Clement, Marcel Romanos, Andreas Karwautz, Paul L Plener, Christoph U Correll, Uwe Malzahn, Peter Heuschmann, Stefan Unterecker, Maike Scherf-Clavel, Hans Rock, Tobias Banaschewski, Hartmut Imgart, Michael Kaess, Tobias Renner, Su-Yin Reuter-Dang, Gerd Schulte-Körne, Frank Theisen, Susanne Walitza, Christian Fleischhaker

Published in

Journal of neural transmission (Vienna, Austria : 1996). Aug 17, 2026. Epub Aug 17, 2026.

Abstract

Although quetiapine is increasingly used off-label in children and adolescents with various psychiatric disorders, there is little evidence on the relationship between quetiapine dose and serum concentration, and therapeutic reference ranges (TRR) have not yet been established for this age group. The aim of this study was to evaluate whether the TRR described for adults is applicable to minors. In addition, the study aimed to investigate the relationship between the daily dose, serum concentration and clinical outcome. The clinical course of 77 patients (females = 78%) aged between 12 and 17 years treated with quetiapine in the multicentre pharmacovigilance study TDM-VIGIL was systematically followed, and serum concentrations were measured. A positive mean correlation was observed between the weight-adjusted daily dose and serum concentration (r_s = 0.580, p < 0.001). Most patients (84.7%) experienced no ADRs or ADRs not significantly interfering with the patients' functioning. A positive linear relationship between the therapeutic response and serum concentration was found (r_s = 0.238, p = 0.006). Only 38.5% of all quetiapine serum concentrations were within the recommended TRR described for adults. Using two different calculation methods, mean ± SD and IQR, our data hinted at considerably lower TRR for minors of about 14-291 ng/ml and 53-234 ng/ml respectively, compared to the suggested TRR for adults. This study has the potential to contribute to the definition of a TRR for quetiapine in minors. However, further controlled studies with larger sample sizes are needed to verify the preliminary results.

PMID:
42606740
Bibliographic data and abstract were imported from PubMed on 18 Aug 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.