ArticlePharmacopsychiatry2022
Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice.
Article in Pharmacopsychiatry, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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Who cites it
19 citing papers in PubMed, 28 citations in OpenAlex.
- Therapeutic drug monitoring in children and adolescents treated with quetiapine for different psychiatric disorders: results of the TDM-VIGIL pharmacovigilance study.Journal of neural transmission (Vienna, Austria : 1996) · 2026Article
- Serum concentrations of selective serotonin reuptake inhibitors and atypical antipsychotics in children and adolescents: data from routine clinical care.Journal of neural transmission (Vienna, Austria : 1996) · 2026Article
- Antipsychotic off-label use in the 21st century: An enduring public health concern.Dialogues in clinical neuroscience · 2025Review
- Off-label drug use in children and adolescents treated with antidepressants and antipsychotics: results from a prospective multicenter trial.Child and adolescent psychiatry and mental health · 2025Article
- External validation of a therapeutic window for risperidone in children with autism spectrum disorder.British journal of clinical pharmacology · 2025Article
- Pharmacogenetic Testing of Children and Adolescents with Mental Health Conditions: Real-World Experiences.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Sex-Specific Differences in Antidepressant and Antipsychotic Treatment Outcomes and Serum Levels in Children and Adolescents.Pharmaceutics · 2025Article
- Therapeutic drug monitoring in children and adolescents with schizophrenia-spectrum, affective, behavioural, tic and other psychiatric disorders treated with aripiprazole: results of the TDM-VIGIL pharmacovigilance study.Journal of neural transmission (Vienna, Austria : 1996) · 2025Article
- Serum Concentration-Dose Relationship and Modulation Factors in Children and Adolescents Treated with Fluvoxamine.Pharmaceutics · 2024Article
- Adverse Drug Reactions Among Hospitalized Psychiatric Patients, Prevalence, Severity, Preventability, and Opportunities for Intervention.Oman medical journal · 2024Article
- Prevalence of use of on-label and off-label psychotropics in the Greek pediatric population.Frontiers in pharmacology · 2024Article
- Therapeutic Drug Monitoring in Children and Adolescents: Findings on Fluoxetine from the TDM-VIGIL Trial.Pharmaceutics · 2023Article
- [Particularities and problems of psychopharmacology in childhood and adolescence].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2023Review
- Value of a web-based pediatric drug information system to prevent serious adverse drug reactions in child and adolescent psychiatry.Journal of neural transmission (Vienna, Austria : 1996) · 2023Article
- The prevalence of off-label use and supratherapeutic blood levels of outpatient psychotropic medication in suicidal adolescents.Frontiers in psychiatry · 2023Article
- Serious Adverse Drug Reactions to Antipsychotics in Minors with Multiple Disabilities: Preventability and Potential Cost Savings by Therapeutic Drug Monitoring.Pharmacopsychiatry · 2023Article
- A Mobile App Leveraging Citizenship Engagement to Perform Anonymized Longitudinal Studies in the Context of COVID-19 Adverse Drug Reaction Monitoring: Development and Usability Study.JMIR human factors · 2022Article
- Therapeutic drug monitoring in children and adolescents with schizophrenia and other psychotic disorders using risperidone.Journal of neural transmission (Vienna, Austria : 1996) · 2022Article
- Protective Effect of Schisandrin on CORT-Induced PC12 Depression Cell Model by Inhibiting Cell Apoptosis In Vitro.Applied bionics and biomechanics · 2022Article
Corrections and comments
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Authors and funding
29 authors at 18 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionDespite the growing evidence base for psychotropic drug treatment in pediatric patients, knowledge about the benefit-risk ratio in clinical practice remains limited. The 'Therapeutic Drug Monitoring (TDM)-VIGIL' study aimed to evaluate serious adverse drug reactions (ADRs) in children and adolescents treated with antidepressants and/or antipsychotics in approved ('on-label'), and off-label use in clinical practice.
methodsPsychiatric pediatric patients aged 6-18 years treated with antidepressants and/or antipsychotics either on-label or off-label were prospectively followed between October 2014 and December 2018 within a multicenter trial. Follow-up included standardized assessments of response, serious ADRs and therapeutic drug monitoring.
results710 youth (age=14.6±2.2 years, female=66.6%) were observed for 5.5 months on average; 76.3% received antidepressants, 47.5% antipsychotics, and 25.2% both. Altogether, 55.2% of the treatment episodes with antidepressants and 80.7% with antipsychotics were off-label. Serious ADRs occurred in 8.3% (95%CI=6.4-10.6%) of patients, mainly being psychiatric adverse reactions (77.4%), predominantly suicidal ideation and behavior. The risk of serious ADRs was not significantly different between patients using psychotropics off-label and on-label (antidepressants: 8.1% vs. 11.3%, p=0.16; antipsychotics: 8.7% vs 7.5%, p=0.67). Serious ADRs occurred in 16.6% of patients who were suicidal at enrollment versus 5.6% of patients who were not suicidal (relative risk 3.0, 95%CI=1.9-4.9).
conclusionOff-label use of antidepressants and antipsychotics in youth was not a risk factor for the occurrence of serious ADRs in a closely monitored clinical setting. Results from large naturalistic trials like ours can contribute to bridging the gap between knowledge from randomized controlled trials and real-world clinical settings.
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