{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,17]],"date-time":"2026-03-17T22:25:27Z","timestamp":1773786327179,"version":"3.50.1"},"reference-count":42,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T00:00:00Z","timestamp":1753833600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"German Federal Institute for Drugs and Medical Devices","award":["V-15322\/68605\/2013-2018"],"award-info":[{"award-number":["V-15322\/68605\/2013-2018"]}]},{"name":"German Federal Institute for Drugs and Medical Devices","award":["001EZ0937"],"award-info":[{"award-number":["001EZ0937"]}]},{"name":"German Federal Ministry of Education and Research","award":["V-15322\/68605\/2013-2018"],"award-info":[{"award-number":["V-15322\/68605\/2013-2018"]}]},{"name":"German Federal Ministry of Education and Research","award":["001EZ0937"],"award-info":[{"award-number":["001EZ0937"]}]},{"name":"Verein zur Durchf\u00fchrung Neurowissenschaftlicher Tagungen e.V.","award":["V-15322\/68605\/2013-2018"],"award-info":[{"award-number":["V-15322\/68605\/2013-2018"]}]},{"name":"Verein zur Durchf\u00fchrung Neurowissenschaftlicher Tagungen e.V.","award":["001EZ0937"],"award-info":[{"award-number":["001EZ0937"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Introduction: Sex-specific differences in psychopharmacological treatment have gained increasing attention in adults, with studies showing that women often have higher serum concentrations of psychotropic drugs due to biological differences. However, despite recognition of these differences in adults, reference ranges for therapeutic drug monitoring (TDM) in general, but even more sex-specific therapeutic windows for psychotropic drugs, are lacking in children and adolescents, who may metabolize and respond to medications differently. Aim: The study aimed to investigate sex-specific differences in antidepressant (AD) and antipsychotic (AP) -treatment outcomes, and pharmacokinetics in childhood\/adolescence. In particular, we examined differences in AD and AP serum levels and clinical effects, including adverse drug effects (ADEs) and therapeutic effectiveness. Methods: This study is part of the multicenter \u201cTDM-VIGIL\u201d pharmacovigilance project, which prospectively followed patients aged 6\u201318 years treated with AD and AP across 18 child psychiatric centers in German-speaking countries from 2014 to 2018. Clinical data, including drug concentrations (AD: fluoxetine, mirtazapine, (es)citalopram, sertraline; AP: aripiprazole, quetiapine, olanzapine, risperidone), were collected using an internet-based registry, and treatment outcomes and ADEs were assessed during routine visits. Statistical analyses were performed to examine sex differences in pharmacokinetics and clinical responses, adjusting for age, weight, and other confounders. Results: A total of 705 patients (66.5% girls, 24.7% &lt;14 years, mean age of 14.6 years) were included. Female patients were slightly older, had lower body weight, and were more often diagnosed with depression and anorexia nervosa, while boys were more frequently diagnosed with hyperkinetic disorders and atypical autism. We found no sex differences in the serum concentrations of investigated drugs when adjusted for age and weight. In fluoxetine treatment in patients diagnosed with mood (affective) disorders, female sex was associated with the probability for very good therapy response (p = 0.04), as well as with moderate treatment response (p = 0.02) compared to no treatment response. Discussion: Our findings suggest that sex may not affect serum levels of investigated AD and AP in children\/adolescents. However, treatment outcome of fluoxetine was associated with sex, with higher probability for a better outcome in female patients diagnosed with mood (affective) disorders.<\/jats:p>","DOI":"10.3390\/pharmaceutics17080983","type":"journal-article","created":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T10:55:37Z","timestamp":1753872937000},"page":"983","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Sex-Specific Differences in Antidepressant and Antipsychotic Treatment Outcomes and Serum Levels in Children and Adolescents"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4780-612X","authenticated-orcid":false,"given":"Maike","family":"Scherf-Clavel","sequence":"first","affiliation":[{"name":"Department of Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1925-6228","authenticated-orcid":false,"given":"Stefanie","family":"Fekete","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital Wuerzburg, 97080 Wuerzburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manfred","family":"Gerlach","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital Wuerzburg, 97080 Wuerzburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7254-5646","authenticated-orcid":false,"given":"Christoph U.","family":"Correll","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Charit\u00e9 Universit\u00e4tsmedizin Berlin, 13353 Berlin, Germany"},{"name":"The Zucker Hillside Hospital, Department of Psychiatry, Northwell Health, Glen Oaks, NY 11004, USA"},{"name":"Donald and Barbara Zucker School of Medicine at Hofstra\/Northwell, Department of Psychiatry and Molecular Medicine, Hempstead, NY 11549, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Plener","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry\/Psychotherapy, University Hospital Ulm, 89075 Ulm, Germany"},{"name":"Department of Child and Adolescent Psychiatry, Medical University Vienna, 1090 Vienna, Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J\u00f6rg M.","family":"Fegert","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry\/Psychotherapy, University Hospital Ulm, 89075 Ulm, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9053-998X","authenticated-orcid":false,"given":"Andreas","family":"Karwautz","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Medical University Vienna, 1090 Vienna, Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Heuschmann","sequence":"additional","affiliation":[{"name":"Institute of Clinical Epidemiology and Biometry, University of Wuerzburg, 97080 W\u00fcrzburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tobias","family":"Banaschewski","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Partner Site Mannheim-Heidelberg-Ulm, 68159 Mannheim, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8253-5070","authenticated-orcid":false,"given":"Wolfgang","family":"Briegel","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital Wuerzburg, 97080 Wuerzburg, Germany"},{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Leopoldina Hospital, 97422 Schweinfurt, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Fleischhaker","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Freiburg, 79104 Freiburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tobias","family":"Hellenschmidt","sequence":"additional","affiliation":[{"name":"Department for Child and Adolescent Psychiatry, Psychotherapy and Psychosomatic Medicine, Vivantes Clinic Berlin Neuk\u00f6lln, 12351 Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hartmut","family":"Imgart","sequence":"additional","affiliation":[{"name":"Parkland-Clinic, Clinic for Psychosomatics and Psychotherapy, Academic Teaching Hospital for the University Gie\u00dfen, 34537 Bad Wildungen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0031-7764","authenticated-orcid":false,"given":"Michael","family":"Kaess","sequence":"additional","affiliation":[{"name":"Clinic for Child and Adolescent Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, 69115 Heidelberg, Germany"},{"name":"Department of Child and Adolescent Psychiatry and Psychotherapy, University Hospital for Child and Adolescent Psychiatry and Psychotherapy, University of Bern, 3000 Bern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2878-5121","authenticated-orcid":false,"given":"Michael","family":"K\u00f6lch","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry and Psychotherapy, Brandenburg Medical School Brandenburg, 16816 Neuruppin, Germany"},{"name":"Department of Child and Adolescent Psychiatry, Neurology, Psychosomatics, and Psychotherapy, University Medical Center Rostock, 18147 Rostock, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karl","family":"Reitzle","sequence":"additional","affiliation":[{"name":"Specialist Practice and Medical Care Center for Child and Adolescent Psychiatry Munich, 81241 Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2151-9480","authenticated-orcid":false,"given":"Tobias J.","family":"Renner","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health Tuebingen, University Hospital of Psychiatry and Psychotherapy Tuebingen, 72076 Tuebingen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Rexroth","sequence":"additional","affiliation":[{"name":"Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy at the Regensburg District Hospital, Medbo KU, University Hospital Regensburg, 93053 Regensburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerd","family":"Schulte-K\u00f6rne","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Ludwig-Maximilians-University (LMU) Hospital, 80097 Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank","family":"Theisen","sequence":"additional","affiliation":[{"name":"Herz-Jesu-Krankenhaus gGmbH, Department of Child and Adolescent Psychiatry and Psychotherapy, 36037 Fulda, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susanne","family":"Walitza","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry and Psychotherapy, University Hospital of Psychiatry Zurich, 8032 Zurich, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christoph","family":"Wewetzer","sequence":"additional","affiliation":[{"name":"Kliniken der Stadt K\u00f6ln gGmbH, Clinic for Child and Adolescent Psychiatry Holweide, Children\u2019s Hospital Amsterdamer Stra\u00dfe, 50825 Cologne, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6786-9702","authenticated-orcid":false,"given":"Franca","family":"Keicher","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital Wuerzburg, 97080 Wuerzburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan","family":"Unterecker","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany"},{"name":"Department of Psychiatry and Psychotherapy, Social Foundation Bamberg\/Michelsberg Clinic, 96047 Bamberg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4026-3561","authenticated-orcid":false,"given":"Sebastian","family":"Walther","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7628-8299","authenticated-orcid":false,"given":"Marcel","family":"Romanos","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital Wuerzburg, 97080 Wuerzburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0270-0954","authenticated-orcid":false,"given":"Karin M.","family":"Egberts","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital Wuerzburg, 97080 Wuerzburg, Germany"},{"name":"Department of Child and Adolescent Psychiatry, GGZ Reinier van Arkel, 5211 LJ \u2018s-Hertogenbosch, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Timo","family":"Vloet","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital Wuerzburg, 97080 Wuerzburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8704-1424","authenticated-orcid":false,"given":"Regina","family":"Taurines","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital Wuerzburg, 97080 Wuerzburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,7,30]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"447","DOI":"10.31887\/DCNS.2016.18.4\/ncutler","article-title":"Sex differences in the psychopharmacological treatment of depression","volume":"18","author":"Sramek","year":"2016","journal-title":"Dialogues Clin. 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