Agomelatine is the first melatonergic antidepressant working as MT1/MT2-agonist and 5-HT2c-antagonist.

Aim of VIVALDI Follow-up was to examine agomelatine-treatment over one year under routine conditions. to evaluate the antidepressant effectiveness and tolerability of agomelatine as well as its effects on sleep-wake-rhythms in depressed patients over one year in daily practice.

Optional 9-months-follow-up of the 3-months non-interventional-study VIVALDI. 605 outpatients were observed by 208 psychiatrists over 12 months in Germany and treated with agomelatine 25–50 mg once daily at bedtime. Antidepressant effectiveness was evaluated by svMADRS (short version MADRS) and CGI scales, effects on sleep and daily activity by a patient questionnaire (CircScreen).

At inclusion, patients had a moderate to severe depression (svMADRS total score 30.6), which improved markedly during the 12 months treatment with agomelatine (svMADRS total Score 9.8). the responder rate (≥50% reduction of svMADRS) rose steadily from 15.3% (2 weeks) to 69.7% (12 weeks) and 75.7% (12 months). 59.6% and 69.8% of patients were in remission (svMADRS ≤12) after 3 and 12 months, respectively. the CGI-S-Score improved from 4.7 to 2.6 after 12 months-treatment with agomelatine. Improvements in falling asleep and daily activities as well as decrease in repeated awakenings were observed after 12 months by 83.6%, 57% and 87.0% of patients, respectively. Adverse drug reactions (mainly headache, dizziness) were reported by only 4.3% of patients.

Antidepressant effectiveness and good tolerability of agomelatine as well as its marked improvement of sleep-wake-rhythms observed in controlled studies were confirmed by this observational trial in daily psychiatric practice over 12 months.