Riegger, Jessica and Egberts, Karin Maria and Clement, Hans-Willi and Schneider-Momm, Katja and Taurines, Regina and Fekete, Stefanie and Wewetzer, Christoph and Karwautz, Andreas and Correll, Christoph U. and Plener, Paul L. and Malzahn, Uwe and Heuschmann, Peter and Unterecker, Stefan and Scherf-Clavel, Maike and Rock, Hans and Antony, Gisela and Briegel, Wolfgang and Banaschewski, Tobias and Hellenschmidt, Tobias and Kaess, Michael and Koelch, Michael and Renner, Tobias and Rexroth, Christian and Schulte-Koerne, Gerd and Walitza, Susanne and Gerlach, Manfred and Romanos, Marcel and Fleischhaker, Christian (2025) Therapeutic drug monitoring in children and adolescents with schizophrenia-spectrum, affective, behavioural, tic and other psychiatric disorders treated with aripiprazole: results of the TDM-VIGIL pharmacovigilance study. JOURNAL OF NEURAL TRANSMISSION, 132 (2). pp. 295-312. ISSN 0300-9564, 1435-1463
Full text not available from this repository. (Request a copy)Abstract
Aripiprazole is approved for various severe mental disorders in adults and adolescents. However, off-label prescribing is common, especially in children and adolescents (youth) in whom aripiprazole therapeutic serum level reference ranges are lacking for any disorders. The aim of the study was to evaluate the relationship between aripiprazole dose and serum concentrations and provide further knowledge on the use of aripiprazole in order to improve drug safety and effectiveness in the treatment of minors. The clinical course of youth treated with aripiprazole in the multicentre pharmacovigilance study TDM-VIGIL was systematically followed and serum concentrations measured. Sex, age, weight and comedications were analysed to identify possible effect modifiers. A preliminary therapeutic reference range was estimated for youth with schizophrenia-spectrum disorders, affective disorders and behavioural/emotional/tic disorders coded as treatment responders based on a Clinical-Global Impressions-Improvement (CGI-I) score of much or very much improved. In 93 youth (mean age = 15.2 +/- 2.6, range = 7.4-18.2 years, females = 53%, CGI-Severity = 4.4 +/- 1.1, responders = 64%), a positive, moderate correlation between the weight-normalized daily dose (WNDD) and aripiprazole serum concentration (=0.791, p < 0.0001) was found. The WNDD and co-medications that interact with CYP2D6 and CYP3A4 affected aripiprazole serum levels, explaining 64% of the variance. In patients within the preliminary therapeutic ranges determined by interquartile ranges (IQRs), slightly better outcomes and fewer adverse drug reactions were found versus patients within preliminary therapeutic ranges determined by the mean +/- SD. The preliminary reference range for paediatric patients with schizophrenia-spectrum disorders calculated by the IQR showed an identical lower threshold (100-230 ng/ml) compared to adult schizophrenia-spectrum disorders patients (100-350 ng/ml). The preliminary therapeutic ranges for patients with affective disorders was: 60-160 ng/ml and for patients with behavioural/tic disorders 60-140 ng/ml. The therapeutic reference ranges for aripiprazole in youth estimated via the 25th and 75th IQRs may result in more clinically relevant therapeutic windows. Further studies need to confirm these results, especially in patients with affective and behavioural/tic disorder diagnoses.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | BIPOLAR-I DISORDER; CONSENSUS GUIDELINES; ACTIVE METABOLITE; DOUBLE-BLIND; 2ND-GENERATION ANTIPSYCHOTICS; PLASMA-CONCENTRATIONS; SERUM CONCENTRATIONS; DEHYDROARIPIPRAZOLE; PLACEBO; EFFICACY; Aripiprazole; Children and adolescents; Serum concentration; Schizophrenia; Affective disorder; Therapeutic drug monitoring |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Kinder- und Jugendpsychiatrie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 07 Apr 2026 11:20 |
| Last Modified: | 07 Apr 2026 11:20 |
| URI: | https://pred.uni-regensburg.de/id/eprint/65565 |
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