Regina Taurines, Manfred Gerlach, Christoph U Correll, Paul L Plener, Uwe Malzahn, Peter Heuschmann, Maike Scherf-Clavel, Hans Rock, Wolfgang Briegel, Christian Fleischhaker, Alexander Häge, Tobias Hellenschmidt, Hartmut Imgart, Michael Kaess, Andreas Karwautz, Michael Kölch, Karl Reitzle, Tobias J Renner, Su-Yin Reuter-Dang, Christian Rexroth, Gerd Schulte-Körne, Frank Theisen, Elvira Tini, Christoph Wewetzer, Stefanie Fekete, Marcel Romanos, Karin M Egberts
{"title":"接受抗抑郁药和抗精神病药治疗的儿童和青少年的超说明书用药：来自一项前瞻性多中心试验的结果","authors":"Regina Taurines, Manfred Gerlach, Christoph U Correll, Paul L Plener, Uwe Malzahn, Peter Heuschmann, Maike Scherf-Clavel, Hans Rock, Wolfgang Briegel, Christian Fleischhaker, Alexander Häge, Tobias Hellenschmidt, Hartmut Imgart, Michael Kaess, Andreas Karwautz, Michael Kölch, Karl Reitzle, Tobias J Renner, Su-Yin Reuter-Dang, Christian Rexroth, Gerd Schulte-Körne, Frank Theisen, Elvira Tini, Christoph Wewetzer, Stefanie Fekete, Marcel Romanos, Karin M Egberts","doi":"10.1186/s13034-025-00957-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Background/objectives: </strong>Off-label psychopharmacologic medication use is widespread in child and adolescent psychiatry, but little is known about its associated factors. This study aimed to assess frequency and determinants of off-label use of antidepressants and antipsychotics in youths in daily clinical practice.</p><p><strong>Methods: </strong>In a prospective clinical study ('TDM-VIGIL') at 18 centers in three German-speaking countries, child psychiatric patients aged 4-18 years undergoing routine treatment with antidepressants and antipsychotics were systematically followed. Demographic, clinical and pharmacological data were collected in an online-based patient registry; off-label use was categorized by reasons, including age, indication or duration of treatment for each treatment episode. Examined correlates of off-label use included sex, treatment setting, diagnosis and illness severity.</p><p><strong>Results: </strong>About 67% of all antidepressant and antipsychotic treatment episodes in the 700 included patients (mean age = 14.6 years, girls = 67%) were off-label. For antidepressants, 55.2% were off-label (age = 51.1%, non-licensed indications = 37.4%, age + indication = 11.5%), for antipsychotics 81.7% were off-label (age = 29.4%, non-licensed indications = 33.2%, age + indication = 37.4%). Sex, age (< 12, ≥ 12 years) as well as illness severity were not associated with off-label use. In antidepressant treatment, 'depression' and 'obsessive compulsive disorder' diagnoses were associated with reduced and 'suicidality at admission' with increased off-label prescriptions. In antipsychotics, 'schizophrenia diagnoses' was linked to decreased, university hospital treatment to increased off-label use.</p><p><strong>Conclusions: </strong>The frequency of off-label use of antidepressants and even more of antipsychotics in youths treated at specialized child psychiatric centers is high. As the clinical efficacy and safety of off-label antidepressant and antipsychotic use in youth is under-researched, our results call for further pharmacovigilance studies and strategies to improve drug safety.</p>","PeriodicalId":9934,"journal":{"name":"Child and Adolescent Psychiatry and Mental Health","volume":"19 1","pages":"110"},"PeriodicalIF":4.6000,"publicationDate":"2025-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12519826/pdf/","citationCount":"0","resultStr":"{\"title\":\"Off-label drug use in children and adolescents treated with antidepressants and antipsychotics: results from a prospective multicenter trial.\",\"authors\":\"Regina Taurines, Manfred Gerlach, Christoph U Correll, Paul L Plener, Uwe Malzahn, Peter Heuschmann, Maike Scherf-Clavel, Hans Rock, Wolfgang Briegel, Christian Fleischhaker, Alexander Häge, Tobias Hellenschmidt, Hartmut Imgart, Michael Kaess, Andreas Karwautz, Michael Kölch, Karl Reitzle, Tobias J Renner, Su-Yin Reuter-Dang, Christian Rexroth, Gerd Schulte-Körne, Frank Theisen, Elvira Tini, Christoph Wewetzer, Stefanie Fekete, Marcel Romanos, Karin M Egberts\",\"doi\":\"10.1186/s13034-025-00957-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background/objectives: </strong>Off-label psychopharmacologic medication use is widespread in child and adolescent psychiatry, but little is known about its associated factors. This study aimed to assess frequency and determinants of off-label use of antidepressants and antipsychotics in youths in daily clinical practice.</p><p><strong>Methods: </strong>In a prospective clinical study ('TDM-VIGIL') at 18 centers in three German-speaking countries, child psychiatric patients aged 4-18 years undergoing routine treatment with antidepressants and antipsychotics were systematically followed. Demographic, clinical and pharmacological data were collected in an online-based patient registry; off-label use was categorized by reasons, including age, indication or duration of treatment for each treatment episode. Examined correlates of off-label use included sex, treatment setting, diagnosis and illness severity.</p><p><strong>Results: </strong>About 67% of all antidepressant and antipsychotic treatment episodes in the 700 included patients (mean age = 14.6 years, girls = 67%) were off-label. For antidepressants, 55.2% were off-label (age = 51.1%, non-licensed indications = 37.4%, age + indication = 11.5%), for antipsychotics 81.7% were off-label (age = 29.4%, non-licensed indications = 33.2%, age + indication = 37.4%). Sex, age (< 12, ≥ 12 years) as well as illness severity were not associated with off-label use. In antidepressant treatment, 'depression' and 'obsessive compulsive disorder' diagnoses were associated with reduced and 'suicidality at admission' with increased off-label prescriptions. In antipsychotics, 'schizophrenia diagnoses' was linked to decreased, university hospital treatment to increased off-label use.</p><p><strong>Conclusions: </strong>The frequency of off-label use of antidepressants and even more of antipsychotics in youths treated at specialized child psychiatric centers is high. As the clinical efficacy and safety of off-label antidepressant and antipsychotic use in youth is under-researched, our results call for further pharmacovigilance studies and strategies to improve drug safety.</p>\",\"PeriodicalId\":9934,\"journal\":{\"name\":\"Child and Adolescent Psychiatry and Mental Health\",\"volume\":\"19 1\",\"pages\":\"110\"},\"PeriodicalIF\":4.6000,\"publicationDate\":\"2025-10-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12519826/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Child and Adolescent Psychiatry and Mental Health\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s13034-025-00957-7\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PEDIATRICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Child and Adolescent Psychiatry and Mental Health","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13034-025-00957-7","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PEDIATRICS","Score":null,"Total":0}
Off-label drug use in children and adolescents treated with antidepressants and antipsychotics: results from a prospective multicenter trial.
Background/objectives: Off-label psychopharmacologic medication use is widespread in child and adolescent psychiatry, but little is known about its associated factors. This study aimed to assess frequency and determinants of off-label use of antidepressants and antipsychotics in youths in daily clinical practice.
Methods: In a prospective clinical study ('TDM-VIGIL') at 18 centers in three German-speaking countries, child psychiatric patients aged 4-18 years undergoing routine treatment with antidepressants and antipsychotics were systematically followed. Demographic, clinical and pharmacological data were collected in an online-based patient registry; off-label use was categorized by reasons, including age, indication or duration of treatment for each treatment episode. Examined correlates of off-label use included sex, treatment setting, diagnosis and illness severity.
Results: About 67% of all antidepressant and antipsychotic treatment episodes in the 700 included patients (mean age = 14.6 years, girls = 67%) were off-label. For antidepressants, 55.2% were off-label (age = 51.1%, non-licensed indications = 37.4%, age + indication = 11.5%), for antipsychotics 81.7% were off-label (age = 29.4%, non-licensed indications = 33.2%, age + indication = 37.4%). Sex, age (< 12, ≥ 12 years) as well as illness severity were not associated with off-label use. In antidepressant treatment, 'depression' and 'obsessive compulsive disorder' diagnoses were associated with reduced and 'suicidality at admission' with increased off-label prescriptions. In antipsychotics, 'schizophrenia diagnoses' was linked to decreased, university hospital treatment to increased off-label use.
Conclusions: The frequency of off-label use of antidepressants and even more of antipsychotics in youths treated at specialized child psychiatric centers is high. As the clinical efficacy and safety of off-label antidepressant and antipsychotic use in youth is under-researched, our results call for further pharmacovigilance studies and strategies to improve drug safety.
期刊介绍：
Child and Adolescent Psychiatry and Mental Health, the official journal of the International Association for Child and Adolescent Psychiatry and Allied Professions, is an open access, online journal that provides an international platform for rapid and comprehensive scientific communication on child and adolescent mental health across different cultural backgrounds. CAPMH serves as a scientifically rigorous and broadly open forum for both interdisciplinary and cross-cultural exchange of research information, involving psychiatrists, paediatricians, psychologists, neuroscientists, and allied disciplines. The journal focusses on improving the knowledge base for the diagnosis, prognosis and treatment of mental health conditions in children and adolescents, and aims to integrate basic science, clinical research and the practical implementation of research findings. In addition, aspects which are still underrepresented in the traditional journals such as neurobiology and neuropsychology of psychiatric disorders in childhood and adolescence are considered.
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