Widespread Off-Label Use of Antidepressants and Antipsychotics in Children and Adolescents

Strategic Insights -

Widespread off-label use of antidepressants and antipsychotics in children and adolescents has been a longstanding concern in the medical community. A recent study conducted at the University Hospital of Wuerzburg in Germany has shed light on the prevalence and factors associated with this practice. The study, published in the journal Child and Adolescent Psychiatry and Mental Health, found that nearly two-thirds of all antidepressant and antipsychotic treatment episodes in children and adolescents were off-label.

Key Takeaways:

  • Nearly 67% of all antidepressant and antipsychotic treatment episodes in the 700 included patients were off-label.
  • For antidepressants, 55.2% were off-label, with age (51.1%), non-licensed indications (37.4%), and age + indication (11.5%) being the primary reasons.
  • For antipsychotics, 81.7% were off-label, with age (29.4%), non-licensed indications (33.2%), and age + indication (37.4%) being the primary reasons.
  • The study found that sex, treatment setting, diagnosis, and illness severity were significant correlates of off-label use.
  • The clinical efficacy and safety of off-label antidepressant and antipsychotic use in youth is under-researched, with the study calling for further pharmacovigilance studies and strategies to improve drug safety.

Statistics:

  • 67% of all antidepressant and antipsychotic treatment episodes were off-label (Source: Child and Adolescent Psychiatry and Mental Health, 2025)
  • 55.2% of antidepressants were off-label, with age (51.1%), non-licensed indications (37.4%), and age + indication (11.5%) being the primary reasons (Source: Child and Adolescent Psychiatry and Mental Health, 2025)
  • 81.7% of antipsychotics were off-label, with age (29.4%), non-licensed indications (33.2%), and age + indication (37.4%) being the primary reasons (Source: Child and Adolescent Psychiatry and Mental Health, 2025)
  • 700 patients were included in the study, with a mean age of 14.6 years and 67% being female (Source: Child and Adolescent Psychiatry and Mental Health, 2025)

Sources:

  • Child and Adolescent Psychiatry and Mental Health, 2025; 19(1):110
  • University Hospital of Wuerzburg
  • Regina Taurines, Dept. of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg, Margarete-Hoeppel-Platz 1, 97080, Wuerzburg, Germany
  • BioMed Central - www.biomedcentral.com/
  • Child and Adolescent Psychiatry and Mental Health - www.capmh.com