Agomelatine is an innovative antidepressant, an MT1, MT2 receptor agonist and a 5-HT2C antagonist now registered in more than 80 countries and is being investigated in noninterventional studies to assess its efficacy and tolerability in daily practice.

Real-world cohorts of outpatients (naïve, with recurrent or severe depression, after switch, or in add-on conditions) were involved in these studies.

In Germany, the VIVALDI study (1) confirmed over a 12-month period the antidepressant efficacy of agomelatine and its improvement of sleep-wake rhythms in 605 depressed patients, as was observed after 3 months, and thus showed convergence with the data observed in controlled studies.

In the prospective French D-Change study, which involved more than 2700 depressed patients, previously treated (switch population) or not with an antidepressant (naïve population), the severity of symptoms was similarly reduced after just 2 weeks in the total population and both subpopulations (2). The results confirmed the clinical benefit of agomelatine in naïve and switch depressed patients. A Slovakian open 8-week study in 111 outpatients also confirmed the antidepressant efficacy of agomelatine as well as improvement of functionality from week 1 and onwards.

The noninterventional trials, conducted in real daily practice conditions, ie, representing the heterogeneous depressed population with severe symptoms and symptoms of anxiety, confirmed the antidepressant efficacy and good tolerability profile of agomelatine. Taken together, the converging data observed both in randomized clinical trials and in prospective trials make agomelatine the treatment of choice for a large spectrum of depressed patients.