The antidepressant efficacy and tolerance of agomelatine, MT1/MT2 agonist and 5-HT2C antagonist, has been proven in clinical trials. Non interventional studies give the opportunity to evaluate these properties in real life.

To evaluate the efficacy and tolerance of agomelatine in depressed outpatients in Switzerland.

Non-interventional study in 934 depressed (51.2% severely) patients given 25–50 mg agomelatine for 12 and 24 weeks. Main endpoints were change in MADRS score, and response (≥50% reduction in total score) and remission (MADRS ≤12) rates. CGI was also assessed. Reported adverse drug reactions, sexual dysfunction, and weight changes were recorded. Liver function tests were performed according to the summary of product characteristics.

MADRS total score decreased significantly (P < 0.0001) from baseline (29.5 ± 8.9) to weeks 12 (12.8 ± 9.6) and 24 (9.7 ± 8.6). Responder rate was 66.8% and 78.3% and remission rate 54.2% and 70.2% at weeks 12 and 24, respectively. Results corroborated by CGI scores, were similar for severely depressed patients. Early improvers (MADRS ≥ 20% reduction after 2 weeks; 461 patients) had the highest responder and remission rates. Agomelatine was well tolerated and no relevant weight changes or deleterious sexual function was reported. Ten patients had ALT/AST>3ULN, thereof 2 without baseline and one with elevated baseline. Most physicians rated the efficacy and tolerance of agomelatine as “good or very good”.

Long-term agomelatine treatment improved mood symptoms of depressed patients with high levels of response and remission and a favorable tolerance profile.

The authors have not supplied their declaration of competing interest.