The safety of agomelatine in standard medical practice in depressed patients: A 26‐week international multicentre cohort study.

Objective: The present observational cohort study documented the safety of agomelatine in current medical practice in out‐patients suffering from major depressive disorder. Method: The 6‐month evolution of agomelatine‐treated patients was assessed with a focus on safety (emergent adverse events, liver acceptability), severity of depression using the Clinical Global Impression Severity (CGI‐S) score, and functioning measured by the Sheehan Disability Scale (SDS). Results: A total of 8453 depressed patients from 761 centres in 6 countries were analysed (female: 67.7%; mean age: 49.1 ± 14.8 years). Adverse events reported were in accordance with the known safety profile of agomelatine. Cutaneous events were reported in 1.7% of the patients and increased hepatic transaminases values were reported in 0.9 % of the patients. The incidence of events related to suicide/self‐injury was 1.0%. Two completed suicides, not related to the study drug, were reported. CGI‐S total scores and SDS sub‐scores improved and numbers of days lost or underproductive decreased over the treatment period. Conclusions: In standard medical practice, agomelatine treatment was associated with a low incidence of side effects. No unexpected events were reported. A decrease in the severity of the depressive episode and improved functioning were observed. Trial registration name: Observational cohort study to evaluate the safety of agomelatine in standard medical practice in depressed patients. A prospective, observational (non‐interventional), international, multicentre cohort study. Trial registration number: ISRCTN53570733 [ABSTRACT FROM AUTHOR]