A Comparative Study of Efficacy and Safety of Agomelatine and Escitalopram in Major Depressive Disorder

Background: Major depressive disorder (MDD) is a mental disorder characterized by episodes of depressed mood, loss of interest or pleasure, feeling of guilt or low self-esteem, loss of energy, altered sleep patterns and difficulty in concentration. Objective: This study was carried out to compare the efficacy and safety of Agomelatine with Escitalopram in the treatment of major depressive disorder. Design and Setting: This is a prospective study conducted at Outpatient Department of Psychiatry, GSL Medical College & General hospital, Rajahmundry, India. Materials and Methods: Patients with newly diagnosed major depressive disorder (DSM-IV-TR) with minimum score of 20 in Hamilton depression rating scale were randomly assigned Agomelatine (25-50 mg/day) or Escitalopram (10-20 mg/day) for a period of 8 weeks. The main efficacy outcome considered was the mean change of HAM-D17 score from baseline to end of therapy. Secondary outcome measures were Clinical Global Impressions-improvement (CGI) and severity (CGI-S) rating scales. Statistical Analysis: Student t-test was used for comparing the groups and chi-square test was used for assessing the qualitative variables. For all statistical analysis p<0.05 was considered statistically significant. Results: The drugs under study effectively reduced depressive symptoms at all the time points. The percentage of responders at 8weeks (last post baseline value) was 65.38% with Agomelatine and 57.40% with Escitalopram. The difference between the drugs was statistically not significant in all evaluations (p>0.05). The mean CGI-S and CGI-I scores were decreased in both the groups (p<0.05) and there was no statistically significant difference between the groups at any assessment during the study period. Both the treatment groups showed favourable safety profile. Conclusion: The study results supported that Agomelatine is therapeutically similar to Escitalopram in terms of antidepressant effect.