ArticleChild and adolescent psychiatry and mental health2025
Off-label drug use in children and adolescents treated with antidepressants and antipsychotics: results from a prospective multicenter trial.
Article in Child and adolescent psychiatry and mental health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Thematic mapping of off-label prescription in psychiatry and its implications for bioethics, human rights, and clinical practice: a scoping review.Frontiers in psychiatry · 2026Pooled it
- Antipsychotic Treatment and Longitudinal Body Mass Index Trajectories in Youth with and Without Autism Spectrum Disorder.Journal of clinical medicine · 2026Article
Corrections and comments
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Authors and funding
27 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
objectivesOff-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.
methodsIn 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.
resultsAbout 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.
conclusionsThe 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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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.