35 outpatients with DSM-IV major depression under agomelatine treatment (25 or 50 mgs/day) were followed up for a minimum of two months. Two groups were identified, one under monotherapy with agomelatine (N=20)and the other (N=15) under combined treatment with another antidepressant or mood stabilizer. Hamilton Depression Rating Scale was administered at first fortnightly and then every month for at least two months. There was a mean reduction in HAM-D at endpoint of 9,7 units on both groups. A greater reduction (11,1 units) was found in the group under 50 mgs/day but he different was marginally statistically significant. Another interesting preliminary finding was that a better outcome was observed in monotherapy patients (- 11 units) in comparison with combined therapy patients (-8,4), a non-significant finding. The most common reported adverse event was headache (14,6%). Also, polytherapy was combined with an older patient age. Other interesting clinical observations are discussed in this ongoing open label study.