Off-label drug use in children and adolescents treated with antidepressants and antipsychotics: results from a prospective multicenter trial.

IF 4.6 3区医学 Q1 PEDIATRICS

Child and Adolescent Psychiatry and Mental Health Pub Date : 2025-10-13 DOI:10.1186/s13034-025-00957-7

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

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引用次数: 0

Abstract

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.

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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

背景/目的：在儿童和青少年精神病学中，超说明书精神药理学药物的使用很普遍，但对其相关因素知之甚少。本研究旨在评估青少年在日常临床实践中超说明书使用抗抑郁药和抗精神病药的频率和决定因素。方法：在一项前瞻性临床研究（“TDM-VIGIL”）中，在三个德语国家的18个中心，系统地随访了4-18岁接受抗抑郁药和抗精神病药物常规治疗的儿童精神病患者。人口统计学、临床和药理学数据收集在一个基于在线的患者登记处；标签外使用按原因分类，包括年龄、适应症或每次治疗的持续时间。研究了标签外使用的相关因素包括性别、治疗环境、诊断和疾病严重程度。结果：在纳入的700例患者（平均年龄= 14.6岁，女孩= 67%）中，约67%的抗抑郁和抗精神病药物治疗是超说明书的。抗抑郁药有55.2%超说明书（年龄= 51.1%，无证适应症= 37.4%，年龄+适应症= 11.5%），抗精神病药有81.7%超说明书（年龄= 29.4%，无证适应症= 33.2%，年龄+适应症= 37.4%）。结论：在专门的儿童精神病学中心接受治疗的青少年中，超说明书使用抗抑郁药物甚至更多抗精神病药物的频率很高。由于青少年使用标签外抗抑郁药和抗精神病药的临床疗效和安全性研究尚不充分，我们的研究结果呼吁进一步的药物警戒研究和策略来提高药物安全性。

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来源期刊

Child and Adolescent Psychiatry and Mental Health PEDIATRICSPSYCHIATRY-PSYCHIATRY

CiteScore

7.00

自引率

3.60%

发文量

审稿时长

16 weeks

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.