{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T02:37:56Z","timestamp":1793241476389,"version":"4.5.0"},"reference-count":55,"publisher":"Georg Thieme Verlag KG","issue":"05","license":[{"start":{"date-parts":[[2022,2,7]],"date-time":"2022-02-07T00:00:00Z","timestamp":1644192000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacopsychiatry"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Introduction Despite the growing evidence base for psychotropic drug\n                    treatment in pediatric patients, knowledge about the benefit-risk ratio in\n                    clinical practice remains limited. The \u2018Therapeutic Drug Monitoring\n                    (TDM)-VIGIL\u2019 study aimed to evaluate serious adverse drug reactions\n                    (ADRs) in children and adolescents treated with antidepressants and\/or\n                    antipsychotics in approved (\u2018on-label\u2019), and off-label use in\n                    clinical practice.<\/jats:p>\n                  <jats:p>Methods Psychiatric pediatric patients aged 6-18 years treated with\n                    antidepressants and\/or antipsychotics either on-label or off-label were\n                    prospectively followed between October 2014 and December 2018 within a\n                    multicenter trial. Follow-up included standardized assessments of response,\n                    serious ADRs and therapeutic drug monitoring.<\/jats:p>\n                  <jats:p>Results 710 youth (age=14.6\u00b12.2 years,\n                    female=66.6%) were observed for 5.5 months on average;\n                    76.3% received antidepressants, 47.5% antipsychotics, and\n                    25.2% both. Altogether, 55.2% of the treatment episodes with\n                    antidepressants and 80.7% with antipsychotics were off-label. Serious\n                    ADRs occurred in 8.3% (95%CI=6.4\u201310.6%)\n                    of patients, mainly being psychiatric adverse reactions (77.4%),\n                    predominantly suicidal ideation and behavior. The risk of serious ADRs was not\n                    significantly different between patients using psychotropics off-label and\n                    on-label (antidepressants: 8.1% vs. 11.3%, p=0.16;\n                    antipsychotics: 8.7% vs 7.5%, p=0.67). Serious ADRs\n                    occurred in 16.6% of patients who were suicidal at enrollment versus\n                    5.6% of patients who were not suicidal (relative risk 3.0,\n                    95%CI=1.9-4.9).<\/jats:p>\n                  <jats:p>Conclusion Off-label use of antidepressants and antipsychotics in youth\n                    was not a risk factor for the occurrence of serious ADRs in a closely monitored\n                    clinical setting. Results from large naturalistic trials like ours can\n                    contribute to bridging the gap between knowledge from randomized controlled\n                    trials and real-world clinical settings.<\/jats:p>","DOI":"10.1055\/a-1716-1856","type":"journal-article","created":{"date-parts":[[2022,2,7]],"date-time":"2022-02-07T19:01:37Z","timestamp":1644260497000},"page":"255-265","source":"Crossref","is-referenced-by-count":30,"title":["Serious Adverse Drug Reactions in Children and Adolescents Treated\n                    On- and Off-Label with Antidepressants and Antipsychotics in Clinical\n                    Practice"],"prefix":"10.1055","volume":"55","author":[{"given":"Karin M.","family":"Egberts","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and\n                    Psychotherapy, Center of Mental Health, University Hospital Wuerzburg,\n                    Wuerzburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manfred","family":"Gerlach","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and\n                    Psychotherapy, Center of Mental Health, University Hospital Wuerzburg,\n                    Wuerzburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christoph U.","family":"Correll","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Charit\u00e9\n                    Universit\u00e4tsmedizin Berlin, Berlin, Germany"},{"name":"The Zucker Hillside Hospital, Department of Psychiatry, Northwell\n                    Health, Glen Oaks, NY, USA"},{"name":"Donald and Barbara Zucker School of Medicine at\n                    Hofstra\/Northwell, Department of Psychiatry and Molecular Medicine,\n                    Hempstead, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul L.","family":"Plener","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry\/Psychotherapy,\n                    University Hospital Ulm, Ulm, Germany"},{"name":"Department of Child and Adolescent Psychiatry, Medical University\n                    Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uwe","family":"Malzahn","sequence":"additional","affiliation":[{"name":"Clinical Trial Center Wuerzburg, University Hospital Wuerzburg,\n                    Wuerzburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Heuschmann","sequence":"additional","affiliation":[{"name":"Clinical Trial Center Wuerzburg, University Hospital Wuerzburg,\n                    Wuerzburg, Germany"},{"name":"Institute of Clinical Epidemiology and Biometry, University of\n                    Wuerzburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Unterecker","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Psychosomatics and Psychotherapy, Center of\n                    Mental Health, University Hospital Wuerzburg, Wuerzburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maike","family":"Scherf-Clavel","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Psychosomatics and Psychotherapy, Center of\n                    Mental Health, University Hospital Wuerzburg, Wuerzburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans","family":"Rock","sequence":"additional","affiliation":[{"name":"Central Information Office, Department of Neurology, Philipps\n                    University of Marburg, Marburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gisela","family":"Antony","sequence":"additional","affiliation":[{"name":"Central Information Office, Department of Neurology, Philipps\n                    University of Marburg, Marburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wolfgang","family":"Briegel","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and\n                    Psychotherapy, Center of Mental Health, University Hospital Wuerzburg,\n                    Wuerzburg, Germany"},{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and\n                    Psychotherapy, Leopoldina Hospital, Schweinfurt, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Fleischhaker","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry and Psychotherapy,\n                    University Medical Center Freiburg, Freiburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"H\u00e4ge","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry and Psychotherapy,\n                    Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg\n                    University, Mannheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias","family":"Hellenschmidt","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychotherapy and\n                    Psychosomatic Medicine, Vivantes Clinic Berlin Neuk\u00f6lln, Berlin,\n                    Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harmut","family":"Imgart","sequence":"additional","affiliation":[{"name":"Parkland-Clinic, Clinic for Psychosomatics and Psychotherapy, Academic\n                    Teaching hospital for the University Gie\u00dfen, Bad Wildungen,\n                    Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Kaess","sequence":"additional","affiliation":[{"name":"Clinic for Child and Adolescent Psychiatry, Center for Psychosocial\n                    Medicine, University Hospital Heidelberg, Heidelberg, Germany"},{"name":"University Hospital of Child and Adolescent Psychiatry and\n                    Psychotherapy, University of Bern, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Karwautz","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Medical University\n                    Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"K\u00f6lch","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry and Psychotherapy,\n                    Brandenburg Medical School Brandenburg, Neuruppin, Germany"},{"name":"Department of Child and Adolescent Psychiatry, Neurology,\n                    Psychosomatics, and Psychotherapy, University Medical Center Rostock, Rostock,\n                    Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karl","family":"Reitzle","sequence":"additional","affiliation":[{"name":"Specialist practice and Medical Care Center for Child and Adolescent\n                    Psychiatry Munich, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias","family":"Renner","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and\n                    Psychotherapy, University Hospital of Psychiatry and Psychotherapy Tuebingen,\n                    Center of Mental Health Tuebingen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Su-Yin","family":"Reuter-Dang","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and\n                    Psychotherapy, Center of Mental Health, University Hospital Wuerzburg,\n                    Wuerzburg, Germany"},{"name":"Specialist practice and Medical Care Center for Child and Adolescent\n                    Psychiatry Munich, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Rexroth","sequence":"additional","affiliation":[{"name":"Clinic for Child and Adolescent Psychiatry, Psychosomatics and\n                    Psychotherapy at the Regensburg District Hospital, Medbo KU, University\n                    Hospital, Regensburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerd","family":"Schulte-K\u00f6rne","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and\n                    Psychotherapy, Ludwig-Maximilians-University (LMU) Hospital, Munich,\n                    Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank M.","family":"Theisen","sequence":"additional","affiliation":[{"name":"Herz-Jesu-Krankenhaus gGmbH, Department of Child and Adolescent\n                    Psychiatry and Psychotherapy, Fulda, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susanne","family":"Walitza","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry and Psychotherapy,\n                    University Hospital of Psychiatry Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christoph","family":"Wewetzer","sequence":"additional","affiliation":[{"name":"Kliniken der Stadt K\u00f6ln gGmbH, Clinic for Child and Adolescent\n                    Psychiatry Holweide, Children\u2019s Hospital Amsterdamer Stra\u00dfe,\n                    Cologne, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefanie","family":"Fekete","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and\n                    Psychotherapy, Center of Mental Health, University Hospital Wuerzburg,\n                    Wuerzburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Regina","family":"Taurines","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and\n                    Psychotherapy, Center of Mental Health, University Hospital Wuerzburg,\n                    Wuerzburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcel","family":"Romanos","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry, Psychosomatics and\n                    Psychotherapy, Center of Mental Health, University Hospital Wuerzburg,\n                    Wuerzburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2022,2,7]]},"reference":[{"key":"ref1","doi-asserted-by":"crossref","first-page":"1333","DOI":"10.1007\/s00228-019-02711-3","article-title":"Prescription prevalence of psychotropic drugs in children and adolescents: An\n                    analysis of international data","volume":"75","author":"D Piovani","year":"2019","journal-title":"Eur J Clin Pharmacol"},{"key":"ref2","doi-asserted-by":"crossref","first-page":"158","DOI":"10.1089\/cap.2017.0077","article-title":"National patterns of commonly prescribed psychotropic medications to young\n                    People","volume":"28","author":"R S Sultan","year":"2018","journal-title":"J Child Adolesc Psychopharmacol"},{"key":"ref3","doi-asserted-by":"crossref","first-page":"416","DOI":"10.1177\/0269881116636107","article-title":"BAP position 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Unmet needs\n                    in paediatric psychopharmacology: Present scenario and future perspectives","volume":"25","author":"A M Persico","year":"2015","journal-title":"Eur Neuropsychopharmacol"},{"key":"ref7","doi-asserted-by":"crossref","first-page":"176","DOI":"10.1186\/1756-0500-3-176","article-title":"Adverse drug reactions from psychotropic medicines in the paediatric population:\n                    Analysis of reports to the Danish Medicines Agency over a decade","volume":"3","author":"L Aagaard","year":"2010","journal-title":"BMC Res Notes"},{"key":"ref8","doi-asserted-by":"crossref","first-page":"629","DOI":"10.1016\/j.euroneuro.2009.04.008","article-title":"Antipsychotics in children and adolescents: Increasing use, evidence for\n                    efficacy and safety concerns","volume":"19","author":"B Vitiello","year":"2009","journal-title":"Eur Neuropsychopharmacol"},{"key":"ref9","doi-asserted-by":"crossref","first-page":"60","DOI":"10.1001\/jamapediatrics.2018.3227","article-title":"Duration of pediatric clinical trials submitted to the US Food and Drug\n                    Administration","volume":"173","author":"K O Zimmerman","year":"2019","journal-title":"JAMA Pediatr"},{"key":"ref10","doi-asserted-by":"crossref","first-page":"481","DOI":"10.1111\/j.1365-2125.2010.03682.x","article-title":"Information about adverse drug reactions reported in children: A qualitative\n                    review of empirical studies","volume":"70","author":"L Aagaard","year":"2010","journal-title":"Br J Clin Pharmacol"},{"key":"ref11","doi-asserted-by":"crossref","first-page":"1063","DOI":"10.1017\/S1461145712001265","article-title":"Polypharmacy with antidepressants in children and adolescents","volume":"17","author":"C M D\u00edaz-Caneja","year":"2014","journal-title":"Int J Neuropsychopharmacol"},{"key":"ref12","doi-asserted-by":"crossref","first-page":"469","DOI":"10.1176\/appi.ajp.159.3.469","article-title":"Are subjects in pharmacological treatment trials of depression representative of\n                    patients in routine clinical practice?","volume":"159","author":"M Zimmerman","year":"2002","journal-title":"Am J Psychiatry"},{"key":"ref13","doi-asserted-by":"crossref","first-page":"511","DOI":"10.1007\/s00787-013-0395-9","article-title":"Antidepressant drug use and off-label-prescribing in children and adolescents in\n                    Germany: Results from a large population-based cohort study","volume":"22","author":"M D\u00f6rks","year":"2013","journal-title":"Eur Child Adolesc Psychiatry"},{"key":"ref14","doi-asserted-by":"crossref","first-page":"500","DOI":"10.1097\/JCP.0000000000000559","article-title":"Off-label-prescription of psychopharmacological drugs in child and adolescent\n                    psychiatry","volume":"36","author":"J V Bra\u00fcner","year":"2016","journal-title":"J Clin Psychopharmacol"},{"key":"ref16","doi-asserted-by":"crossref","first-page":"806","DOI":"10.1089\/cap.2016.0202","article-title":"Extend and Risk of Antipsychotic Off-Label-Use in Children and Adolescents in\n                    Germany between 2004 and 2011","volume":"27","author":"C Schr\u00f6der","year":"2017","journal-title":"J Child and Adolesc Psychopharmacol"},{"key":"ref17","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1186\/1753-2000-2-24","article-title":"Off-label psychopharmacologic prescribing for children: History supports close\n                    clinical monitoring","volume":"2","author":"J M Zito","year":"2008","journal-title":"Child and Adolescent Psychiatry and Mental Health"},{"key":"ref18","first-page":"61","volume-title":"Special features of psychopharmacological therapy in children and adolescents.\n                    Gerlach M, Warnke A, Greenhill L, eds. 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