Agomelatine, a melatonergic agonist and 5-HT_2c-antagonist, has demonstrated antidepressant efficacy and safety in clinical trials.

Metaanalysis of non-interventional-studies of agomelatine-treatment in depression to evaluate tolerability and antidepressant effectiveness of agomelatine under routine conditions in a large patient-population in Germany.

Pooled data-analysis from 4 non-interventional-studies (2009-2013). 9601 outpatients aged>18 years were observed by 2770 psychiatrists and general practitioners in Germany. Analysis was performed after 12 weeks (W12) and after 24/52 weeks (W24/W52) of treatment with agomelatine 25-50mg once daily. Antidepressant effectiveness was evaluated by Clinical-Global-Impression-Severity/Improvement (CGI-S/I). Liver-function-tests (LFT) were documented as available, ADRs at every visit.

Baseline CGI-S mean-value (4.7) improved over 12/24/52 weeks of treatment with agomelatine (to 3.0/2.8/2.6), corresponding improvement in 81%/82%/87% of patients. According to CGI-I, 24.3% responded (CGI-I≤2) after 2 weeks, 63.0% (W6), 87.7% (W12), 79.3% (W24) and 81.7% (W52). 34.5% of patients were classified as remitters (CGI-S=1 or 2) after 12 weeks, 38.1% (W24) and 47.5% (W52). Adverse drug reactions (mainly headache, nausea, dizziness) were reported for 5.32% (W12), 0.49% (W12-W24) and 0.99% (W24-M12) of patients, sADR in 0.2%/0.05%/0%. 49 patients (0.5%) had ALT/AST>3ULN (W0-W13), thereof 19 patients with preexisting transaminase-elevations at baseline. One patient with reversible hepatitis was documented (W10-W17), treatment was stopped. All other patients were without clinical symptoms. Mean weight (76.9 vs 77.0kg) and BMI (26.4 vs 26.5) remained unchanged.

This metaanalysis documents good tolerability of agomelatine and antidepressant effectiveness in a large population of unselected patients in German daily practice over 3, 6 and 12 months.