Assessment of the prognostic value of clinical factors for the development of adverse reactions to antipsychotics in children and adolescents with behavioral disorders: an observational study

Aysin F.R., Che M.D., Roshchina E.A., Sychev D.A., Ivashchenko D.V.

1) G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents, Moscow Healthcare Department, Moscow, Russia; 2) World-Class Genomic Research Center “Center for Predictive Genetics, Pharmacogenetics, and Personalized Therapy,” B.V. Petrovsky National Research Center of Surgery (Ministry of Science and Higher Education of the Russian Federation), Moscow, Russia; 3) Russian Medical Academy of Continuous Professional Education, Moscow, Russia

Background: Antipsychotics (APs) are used to manage behavioral disorders in children and adolescents, but their use is associated with a risk of adverse drug reactions (ADRs). Data on differences in the ADR profile between children and adolescents, as well as on clinical and demographic risk factors, remain limited.
Objective: To investigate clinical and demographic risk factors for antipsychotic-induced ADRs in children and adolescents with behavioral disorders.
Material and methods. A prospective observational study was conducted in male inpatients admitted to a psychiatric hospital in 2023–2024. Two age groups were examined: children (7–12 years) and adolescents (13–17 years) with behavioral disorders as indications for AP treatment. Safety was assessed on days 5, 10, and 14 using the UKU Side Effect Rating Scale (UKU SERS), Simpson–Angus Scale (SAS), and Barnes Akathisia Rating Scale (BARS). Statistical analysis was performed in R 4.4.3 using Fisher’s exact test, Wilcoxon test, Pearson’s χ²-test, McNemar’s test, and logistic and linear regression models.
Results: The study included 120 male patients: 61 children and 59 adolescents. In the total sample, significant differences in UKU scores were found over time (p<0.001): the total UKU score on day 14 (0) differed significantly from that on day 5 (1; p<0.001) and day 10 (1; p=0.004). On day 14, children had higher total UKU scores than adolescents (1 vs 0; p=0.024). Concomitant antidepressant or anxiolytic therapy and antipsychotic duplication also influenced UKU scores. Asthenia was more frequent in children than in adolescents on day 10 (8.6% vs 1.1%; p=0.032) and day 14 (11.9% vs 2.5%; p=0.016). Regression analysis did not identify any statistically significant models.
Conclusions: Among male patients, adolescents showed rapid adaptation to ADRs, unlike children. The main risk factors for ADRs in children with behavioral disorders were antipsychotic duplication and concomitant use of antidepressants and anxiolytics.

For citations: Aysin F.R., Che M.D., Roshchina E.A., Sychev D.A., Ivashchenko D.V.  of the prognostic value of clinical factors for the development of adverse reactions to antipsychotics in children and adolescents with behavioral disorders: an observational study. Pharmateca. 2026;33(7):72-79. (In Russ.). DOI: https://dx.doi.org/10.18565/pharmateca.2026.7.72-79

Authors’ contribution: F.R. Aysin – study design, data collection, manuscript drafting, data analysis, data visualization. M.D. Che, E.A. Roshchina – data collection. D.A. Sychev – study design, editing the final manuscript. D.V. Ivashchenko – study design, manuscript drafting, editing the final manuscript.
Conflicts of interest: The authors confirm that they have no conflicts of interest to declare.
Funding: The study was conducted without any sponsorship.
Ethical Approval: Approval: The study design was approved by the local ethics committee of the G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents (Moscow Healthcare Department) (Protocol No. 2/23 dated May 17, 2023).
Patient Consent for Publication: All patients or their legal representatives provided informed consent for the publication of their data.
Authors’ Data Sharing Statement: The data supporting the findings of this study are available upon request from the corresponding author after approval from the principal investigator.

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About the Authors

Farid R. Aysin, Clinical Pharmacologist, G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents, Moscow, Russia; aysinf@yandex.ru, ORCID: https://orcid.org/0000-0003-1145-1600 (corresponding author)
Mikhail D. Che, Psychiatrist, G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents, Moscow, Russia; ORCID: https://orcid.org/0009-0007-3949-5329
Ekaterina A. Roshchina, Psychiatrist, G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents, Moscow, Russia; ORCID: https://orcid.org/0009-0001-3589-058X
Dmitry A. Sychev, Dr. Sci. (Med.), Professor, Professor of the Russian Academy of Sciences, Academician of the Russian Academy of Sciences; World-Class Genomic Research Center «Center for Predictive Genetics, Pharmacogenetics, and Personalized Therapy,» Petrovsky National Research Center of Surgery (Ministry of Science and Higher Education of the Russian Federation); Head of the Russian Medical Academy of Continuous Professional Education (Head of the Academic Department of Clinical Pharmacology and Therapy named after Academician B.E. Votchal; Chief Specialist in Clinical Pharmacology), Moscow, Russia; ORCID: https://orcid.org/0000-0002-4496-3680
Dmitry V. Ivashchenko, Dr. Sci. (Med.), Associate Professor, Chief Researcher, G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents, Moscow, Russia; ORCID: https://orcid.org/0000-0002-2295-7167

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