The effectiveness and tolerability of agomelatine in the treatment of
depression after COVID-19 infection in Russian daily clinical practice
(TELESPHOR study)
Abstract
Aim: Affective disorders such as depression and anxiety are one
of the most prevalent symptoms observed in patients following
coronavirus disease 2019 (COVID-19). The aim of the TELESPHOR study was
to evaluate the antidepressant effectiveness and tolerability of
agomelatine therapy in daily clinical practice in patients with major
depressive episodes (MDE) post-COVID-19. Methods: This
multicenter, observational study enrolled outpatients aged 18-65 years
who experienced an MDE (17 item Hamilton Rating Scale for Depression
[HAMD-17] total score of 8-24) within 3 months of laboratory
confirmed SARS-CoV-2 infection and who had initiated treatment with
agomelatine. Study visits occurred at weeks 2, 4 and 8. The primary
outcome was the antidepressant effectiveness of agomelatine assessed by
change in HAMD-17 total score at week 8. Secondary outcomes included
changes in HAMD-17 item 10 (anxiety psychic) and item 11 (anxiety
somatic), the proportion of responders (≥50% decrease in baseline
HAMD-17) and remitters (HAMD-17 score ≤7 at week 8), and impact on
quality of life (QoL) (Short Form Survey [SF-36] questionnaire).
Tolerability was assessed at each study visit. Results: The
full analysis set comprised 103 patients of whom 73 (70.9%) were women.
Median age was 45 years, and in the past 3 months 81 (78.6%) had
experienced mild and 22 (21.4%) moderate COVID-19. The mean time from
onset of infection to study inclusion was 2.1±0.7 months. At study
entry, 55 (53.4%) had mild and 48 (46.6%) had moderate MDE.
Agomelatine was associated with a significant improvement in depression
severity with decreases in mean total HAMD-17 score compared with
baseline of 2.6±3.3, 6.7±5.3, and 10.9±4.9 at weeks 2, 4, and 8,
respectively (P<0.0001 for all). Significant reductions in
anxiety psychic and anxiety somatic were also observed. Mental and
physical components of SF-36 were significantly improved compared with
baseline (P<0.0001). The proportion of responders was 81.4%
and the proportion of remitters was 71.6%. Agomelatine was well
tolerated over the 8-week follow-up. Conclusion: Treatment with
agomelatine was associated with rapid and significant antidepressive and
anxiolytic effectiveness, improved QoL, and good tolerability in the
treatment of patients with an MDE after COVID-19.