EFFICACY AND SAFETY OF AGOMELATINE IN TREATMENT OF MAJOR DEPRESSIVE DISORDER: A PILOT STUDYAbstract
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-HT2C 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.
Srikrishna Nukala *, Ravi Babu Komaram , Jayasree Palla and Murthy KSN
Department of Psychiatry, GITAM Institute of Medical Sciences and Research, Visakhapatnam, Andhra Pradesh, India
02 April, 2016
09 May, 2016
31 May, 2016
01 August 2016