Safety of antidepressant therapy in suicidal adolescents with depression: an observational risk factor analysis

Sobur V.V., Grass S.V., Basova A.Ya., Kondratyeva R.V., Shagovenko E.N., Chernetsova Yu.V., Korsakov I.N., Shevchenko Yu.S., Sychev D.A., Ivaschenko D.V.

1) G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents of the Moscow Healthcare Department, Moscow, Russia; 2) Russian Medical Academy of Continuous Professional Education, Moscow, Russia; 3) Petrovsky National Research Centre of Surgery, Moscow, Russia

Background: Depressive episodes (DE) are common among adolescents. They are often accompanied by suicidal tendencies and require safe treatment. Selective serotonin reuptake inhibitors (SSRIs) are the first-line therapy. However, their use in children is often off label, and safety data in real-world clinical practice and under polypharmacy remain limited.
Objective: To assess the frequency and structure of adverse drug reactions (ADRs) in adolescents with depressive episodes and suicidal tendencies receiving sertraline or fluvoxamine, and to identify ADR risk factors associated with polypharmacy.
Materials and methods: A prospective observational study was conducted in 173 patients (aged 12–17 years) with depressive syndrome and suicidal ideation/attempts hospitalized in a psychiatric hospital. Patients received sertraline (n=133) or fluvoxamine (n=40). ADRs were recorded on days 7, 21, and at week 8 using a standardized questionnaire. Concomitant therapy was documented. The study was approved by the local ethics committee.
Results: Overall, 88,4% of patients received additional therapy. The overall ADR profile was comparable between the groups, despite higher doses in the sertraline subgroup. Polypharmacy significantly increased ADRs: the addition of antipsychotics to fluvoxamine increased somatic and total ADRs; the addition of mood stabilizers to sertraline increased somatic ADRs; tranquilizers affected appetite differently depending on the SSRI.
Discussion: Our findings indicate that the choice of SSRI does not determine the ADR spectrum; polypharmacy is the leading risk factor. Tranquilizers may produce paradoxical effects on appetite. The rarity of dangerous drug interactions likely reflects clinicians’ caution.
Conclusion: Significant risk factors for ADRs are the addition of antipsychotics to fluvoxamine, the addition of mood stabilizers to sertraline, and the use of tranquilizers. The choice between sertraline and fluvoxamine per se does not affect the frequency or pattern of ADRs. These results emphasize the need for careful monitoring of patients on combination therapy.

For citations: Sobur V.V., Grass S.V., Basova A.Ya., Kondratyeva R.V., Shagovenko E.N., Chernetsova Yu.V., Korsakov I.N., Shevchenko Yu.S., Sychev D.A., Ivaschenko D.V. Safety of antidepressant therapy in suicidal adolescents with depression: an observational risk factor analysis. Pharmateca. 2026;33(7):88-97. (In Russ.). DOI: https://dx.doi.org/10.18565/pharmateca.2026.7.88-97

Authors’ contribution: V.V. Sobur – patient recruitment, maintenance of research documentation, data analysis, preparation and editing of the manuscript. S.V. Grass – patient recruitment, clinical assessment of patients, contribution to the preparation of the text. A.Ya. Basova – contribution to the preparation of the text, methodological support. R.V. Kondratyeva – patient recruitment, collection of primary data, maintenance of research documentation. E.N. Shagovenko – patient recruitment, collection of primary data, maintenance of research documentation. Yu.V. Chernetsova – patient recruitment, collection of primary data, maintenance of research documentation. I.N. Korsakov – statistical analysis, data visualization. Yu.S. Shevchenko – contribution to the preparation of the text, methodological support. D.A. Sychev – contribution to the development of the research concept. D.V. Ivaschenko – research concept and design, scientific supervision, final editing of the manuscript.
All authors have approved the final version of the article and are responsible for its content.
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: The study was approved by the local ethics committee of the G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents of the Moscow Healthcare Department (Protocol No. 2/23 dated May 17, 2023).
Patient Consent for Publication: All patients 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

Vitaliy V. Sobur, Junior Researcher, Child Psychiatrist, G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents of the Moscow Healthcare Department, Moscow, Russia; vitalijsobur@gmail.com, ORCID: https://orcid.org/0000-0002-3162-2115, eLibrary SPIN: 6064-7550, AuthorID: 1231830 (corresponding author)
Sergey V. Grass, Child Psychiatrist, G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents of the Moscow Healthcare Department, Moscow, Russia; grasss1987@gmail.com, ORCID: https://orcid.org/0009-0007-3327-5130, eLibrary SPIN: 3759-9880, AuthorID: 1311835
Anna Ya. Basova, Cand. Sci. (Med.), Deputy Director for Research, G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents of the Moscow Healthcare Department, Moscow, Russia; anna@alienist.ru, ORCID: https://orcid.org/0000-0002-5001-8554, eLibrary SPIN: 3290-5781, AuthorID: 689319
Rimma V. Kondratyeva, Child Psychiatrist, G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents of the Moscow Healthcare Department, Moscow, Russia; ORCID: https://orcid.org/0000-0002-9576-8447
Evgeniya N. Shagovenko, Head of Department, Child Psychiatrist, G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents of the Moscow Healthcare Department, Moscow, Russia; ORCID: https://orcid.org/0009-0002-9016-5521
Yulia V. Chernetsova, Head of Department, Child Psychiatrist, G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents of the Moscow Healthcare Department, Moscow, Russia; ORCID: https://orcid.org/0009-0001-0631-4997
Ivan N. Korsakov, Cand. Sci. (Med.), Petrovsky National Research Centre of Surgery, Moscow, Russia; ivan@korsakov.su, ORCID:
https://orcid.org/0009-0006-2521-7275, eLibrary SPIN: 6109-6951, AuthorID: 738470
Yuri S. Shevchenko, Dr. Sci. (Med.), Professor, Acting Head of the Department of Child Psychiatry and Psychotherapy, Russian Medical Academy of Continuous Professional Education, Moscow, Russia; europsy@mail.ru, ORCID: https://orcid.org/0000-0001-9871-8704, eLibrary SPIN: 2430-1912, AuthorID: 587038
Dmitry A. Sychev, Dr. Sci. (Med.), Professor, Professor of the Russian Academy of Sciences, Academician of the Russian Academy of Sciences, Russian Medical Academy of Continuous Professional Education, Moscow; Petrovsky National Research Centre of Surgery, Moscow, Russia; dmitry.alex.sychev@gmail.com, ORCID: https://orcid.org/0000-0002-4496-3680, eLibrary SPIN: 4525-7556, AuthorID: 562856
Dmitry V. Ivaschenko, Dr. Sci. (Med.), Associate Professor, Chief Researcher, G.E. Sukhareva Scientific and Practical Center for Mental Health of Children and Adolescents of the Moscow Healthcare Department, Moscow; Petrovsky National Research Centre of Surgery, Moscow, Russia; dvi1991@yandex.ru, ORCID: https://orcid.org/0000-0002-2295-7167, eLibrary SPIN: 9435-7794, AuthorID: 688603

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