EFFICACY AND SAFETY OF AGOMELATINE IN TREATMENT OF MAJOR DEPRESSIVE DISORDER: A PILOT STUDY

Back ground: Agomelatine is a novel antidepressant which acts through a combination of agonistic actions at MT₁ and MT₂ subtypes of  Mela­tonergic receptors and antagonistic actions at 5-HT2_C subtype of serotonergic receptors. Objective: The study was carried out to evaluate the efficacy and safety of Agomelatine in the treatment of Major depressive disorder. Method: A prospective study  was conducted at outpatient department of Psychiatry, GSL Medical College & General hospital Rajahmundry, 76 outpatients between 18 to 65 yrs of age of either sex, who met DSM-IV-TR criteria for major depressive disorder and had a minimum depression score of  20 on HAM-D17 were assigned to 8weeks of treatment with Agomelatine (25-50 mg/day). The main efficacy outcome measured was HAM-D17 total score (change from baseline to last post-baseline assessment of 8 weeks). Secondary outcome measures were assessed on Clinical Global Impression- severity (CGI-S) and Clinical Global Impression–improvement (CGI-I) scales. Results: The study results showed that Agomelatine was effective in Major depressive disorder. HAM-D17 score reduced effectively from baseline to end of week 8 (p<0.05). The percentage of responders and remitters at end of week 8 were 56.57% and 26.31% respectively. The mean CGI-S and CGI-I scores improved from baseline to end of week 8 (P<0.05). Conclusion: Agomelatine as a novel agent with a unique pharmacological profile, showed good efficacy in reducing the symptoms of Major depressive disorder.