Frey, Michael and Smigielski, Lukasz and Tini, Elvira and Fekete, Stefanie and Fleischhaker, Christian and Wewetzer, Christoph and Karwautz, Andreas and Correll, Christoph U. and Gerlach, Manfred and Taurines, Regina and Plener, Paul L. and Malzahn, Uwe and Kornbichler, Selina and Weninger, Laura and Brockhaus, Matthias and Reuter-Dang, Su-Yin and Reitzle, Karl and Rock, Hans and Imgart, Hartmut and Heuschmann, Peter and Unterecker, Stefan and Briegel, Wolfgang and Banaschewski, Tobias and Fegert, Joerg M. and Hellenschmidt, Tobias and Kaess, Michael and Koelch, Michael and Renner, Tobias and Rexroth, Christian and Walitza, Susanne and Schulte-Koerne, Gerd and Romanos, Marcel and Egberts, Karin Maria and Magni, Paolo (2023) Therapeutic Drug Monitoring in Children and Adolescents: Findings on Fluoxetine from the TDM-VIGIL Trial. PHARMACEUTICS, 15 (9): 2202. ISSN , 1999-4923
Full text not available from this repository. (Request a copy)Abstract
Fluoxetine is the recommended first-line antidepressant in many therapeutic guidelines for children and adolescents. However, little is known about the relationships between drug dose and serum level as well as the therapeutic serum reference range in this age group. Within a large naturalistic observational prospective multicenter clinical trial ("TDM-VIGIL"), a transdiagnostic sample of children and adolescents (n = 138; mean age, 15; range, 7-18 years; 24.6% males) was treated with fluoxetine (10-40 mg/day). Analyses of both the last timepoint and all timepoints (n = 292 observations), utilizing (multiple) linear regressions, linear mixed-effect models, and cumulative link (mixed) models, were used to test the associations between dose, serum concentration, outcome, and potential predictors. The receiver operating curve and first to third interquartile methods, respectively, were used to examine concentration cutoff and reference values for responders. A strong positive relationship was found between dose and serum concentration of fluoxetine and its metabolite. Higher body weight was associated with lower serum concentrations, and female sex was associated with lower therapeutic response. The preliminary reference ranges for the active moiety (fluoxetine+norfluoxetine) were 208-328 ng/mL (transdiagnostically) and 201.5-306 ng/mL (depression). Most patients showed marked (45.6%) or minimal (43.5%) improvements and reported no adverse effects (64.9%). This study demonstrated a clear linear dose-serum level relationship for fluoxetine in youth, with the identified reference range being within that established for adults.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | SEROTONIN REUPTAKE INHIBITORS; PLASMA-CONCENTRATIONS; SERUM CONCENTRATIONS; SEX-DIFFERENCES; CLINICAL IMPROVEMENT; DEPRESSIVE DISORDER; ANTIDEPRESSANTS; CYP2D6; PHARMACOKINETICS; EFFICACY; TDM; adolescents; depression; antidepressants; selective serotonin reuptake inhibitors; pharmacovigilance; steady-state concentration; reference range |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Psychiatrie und Psychotherapie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 31 Jan 2024 12:25 |
| Last Modified: | 31 Jan 2024 12:25 |
| URI: | https://pred.uni-regensburg.de/id/eprint/60912 |
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