Agomelatine is a melatonergic agonist and 5-HT_2C antagonist with demonstrated antidepressant efficacy in clinical trials. The aim of the non-interventional study VIVALDI was to examine the antidepressant efficacy and tolerability of agomelatine in depressed patients in daily practice.

3317 outpatients aged >18 years with first or recurrent depressive episodes were observed by 665 German psychiatrists over 12 weeks. Patients were treated with agomelatine 25–50mg once daily at bedtime. Antidepressant efficacy was evaluated by the svMADRS (short version MADRS) and CGI scales, effects on sleep and daily activity by a patient questionnaire (CircScreen).

At inclusion, patients showed moderate to severe depression (svMADRS: 0=30.6), demonstrating an steady and marked clinical improvement during the 12 weeks of agomelatine treatment (svMADRS: 0=12.8). The responder rate (≥50% reduction of svMADRS) rose steadily from 12.3% (2 weeks) to 42.7% (6 weeks) and 65.8% (12 weeks). After 3 months, 54.8% of patients were in remission (svMADRS ≤12). On the CGI scale, 22.8% of patients responded (CGI-I ≤2) after 2 weeks and 72.4% after 12 weeks of treatment with agomelatine. Decrease in repeated and early morning awakenings, and increase daily activities were observed after 12 weeks in 81.5%, 82% and 56.6% of patients, respectively. The tolerability of agomelatine was good.

The antidepressant efficacy of agomelatine on depressive symptoms and daytime activities, as well as its tolerability observed in controlled trials were confirmed by the results of the non-interventional study VIVALDI.