Early effect on general interest, and short-term antidepressant efficacy and safety of agomelatine (25-50 mg/day) and escitalopram (10-20 mg/day) in outpatients with Major Depressive Disorder. A 12-week randomised double-blind comparative study

- Agomelatine is associated with an improved general interest of outpatients.
- This antidepressant relieves depressive symptoms and functional impairment.
- The good tolerability of this treatment is confirmed over 12 weeks.

BackgroundA double-blind, randomized, study was conducted in 29 centers in Romania to evaluate the effect of agomelatine 25-50 mg/day (n=144 patients) on general interest, overall clinical efficacy, and functionality in comparison with escitalopram 10-20 mg/day (n=143 patients) in out-patients diagnosed with moderate to severe Major Depressive Disorder (MDD).MethodsThe primary endpoint of the study was the score difference between agomelatine and escitalopram were assessed on the item 13 of the Quick Inventory of Depressive Symptomatology (16-Item) Self-Report (QIDS-SR16) over the first week period. Secondary measures include the primary criterion on the 12-week period, the within-group evolution over 12 weeks of the 17-item Hamilton Depression Scale (HAM-D17) total score, CGI severity of illness (CGI-S) and CGI-I scores, and functionality by using the self-rated Sheehan Disability Scale (SDS).ResultsAfter one week, the mean General Interest score showed no statistically significant difference between treatments. Over 12 weeks, patients felt more and more interested in other people and activities than before having taken medication. Both agomelatine and escitalopram improved depressive symptoms and symptom-related functional impairment of patients. Both agomelatine and escitalopram were well-tolerated by patients.LimitationsThe strength of our results would benefit from additional data from trials using a similar design and other active comparators.ConclusionThere was no difference in week 1 changes of interest between agomelatine and escitalopram. The relatively good tolerability of agomelatine and escitalopram is confirmed.