Antidepressant and anxiolytic efficacy and tolerability of agomelatine in the treatment of depression after COVID-19 in daily clinical practice (non-interventional study TELESPHOR); [Антидепрессивная и противотревожная эффективность и переносимость агомелатина при лечении депрессии после перенесенного COVID-19 в повседневной клинической практике (неинтервенционное исследование TELESPHOR)]

Depression and anxiety are among the most common disorders observed in patients after COVID-19 coronavirus infection. Objective: to evaluate the antidepressant efficacy and tolerability of agomelatine in patients with a depressive episode (DE) after COVID-19 infection in everyday clinical practice. Material and methods. The multicenter observational study TELESPHOR included outpatients aged 18 to 65 years who developed DE (Hamilton Depression Rating Scale (HAMD-17) score of 8–24) within 3 months of the resolution of a laboratory-confirmed COVID-19 infection and started monotherapy with agomelatine. Patients were assessed at enrolment and subsequently at weeks 2, 4 and 8 of the observation period. The primary endpoint was the change in HAMD-17 scores by week 8 of the observation in patients taking agomelatine as an antidepressant. The main secondary outcome variables were the dynamics of scores for items 10 (psychic anxiety) and 11 (somatic anxiety) of the HAMD-17 scale, the proportion of responders and remitters (according to the HAMD-17 scale) and the impact on quality of life (QOL) according to the SF-36 questionnaire. The tolerability of agomelatine was assessed at each visit. Data from all patients who participated in the study and took agomelatine at least once were included in the efficacy and safety analysis. The final analysis included data from 103 patients, including 73 women (70.9%). Results. Treatment with agomelatine was associated with a significant improvement in depression severity: the mean HAMD-17 total score decreased statistically significantly at weeks 2, 4 and 8 from 16.3±4.7 at study inclusion to 13.7±4.5, 9.5±4.9 and 5.4±3.6 points – by 2.6±3.3, 6.7±5.3 and 10.9±4.9 points, respectively, compared to baseline (p<0.0001 for all time points). The average score for item 10 (psychic anxiety) and item 11 (somatic anxiety) of the HAMD-17 scale also decreased significantly from 1.4±0.9 and 1.3±0.8 at baseline to 0.5±0.6 and 0.6±0.6 points by the eighth week of observation (p<0.0001). The indicators of the scales for physical functioning and mental health of the SF-36 questionnaire improved significantly compared to the initial values – from 39.7±8.4 to 50.5±5.7 points (p<0.0001) and from 37.3±8.6 to 58.7±6.9 points (p<0.0001) respectively, by the eighth week. The proportion of responders was 81.4 %, the proportion of remitters was 71.6%. Agomelatine was well tolerated during the entire observation period. No adverse events were recorded that led to discontinuation of the drug. One patient showed inefficacy of the treatment, so he discontinued participation in the study. Conclusion. The treatment of patients with DE after COVID-19 with agomelatine is characterized by significant antidepressant and anxiolytic efficacy, improved QOL and good tolerability. © 2024 Ima-Press Publishing House. All rights reserved.