Real World Comparative Study to Assess the Efficacy and Safety of Antidepressant Therapies for Treatment of Patients With Major Depressive Disorder in India

Abstract

Introduction newlineMajor depressive disorder (MDD) is one of the leading causes of non-fatal disease burden in newlineIndia. Limited clinical data on antidepressants indicates the need for more real-world evidence. newlineThis study compared the efficacy and safety of Escitalopram, Sertraline, and Amitriptyline in newlinepatients with MDD. Additionally, a subset analysis was performed to compare patient newlineoutcomes of concurrent medications (polytherapy) versus monotherapy. newlineMethods newlineThis observational study was conducted at Lokmanya Tilak Municipal Medical College and newlineGeneral Hospital, Mumbai, India, from May 2021 to April 2023. Patients of all ages with newlineMDD, having Hamilton Depression Rating Scale-17 (HAM-D 17) scores and#8805;15 or Clinical newlineGlobal Impression-Severity of illness (CGI-S) score and#8805;3, were included if prescribed one of newlinethree study drugs. Primary endpoint was change in HAM-D 17 scores from baseline to Week newline8. Additionally, subset analysis compared HAM-D scores of polytherapy versus monotherapy. newlineEthical approval and informed consent were obtained per guidelines. newlineResults newlineOverall, 268 patients were enrolled in the study (Escitalopram [n=101]; Sertraline [n=87]; newlineAmitriptyline [n=80]). Although HAM-D 17 scores reduced over time in each cohort, the newlinechange from baseline for Escitalopram was significantly higher than Sertraline (plt0.005) and newlineAmitriptyline cohorts (plt0.005). At Week 8, Clinical Global Impression, European Quality of newlineLife Five Dimension Five Level-health states, visual analogue scale, and Columbia-Suicide newlineSeverity Rating Scale (C-SSRS) scores in the Escitalopram cohort were significantly lower newlinethan Sertraline (plt0.005 each) and Amitriptyline cohorts (plt0.005 each). Adverse events were newlinereported by 245 (91.4%) patients during the study. In the subset analysis, polytherapy (n=91) newlineelicited significantly higher reductions in HAM-D scores than monotherapy (n=177) at all time newlinepoints (plt0.005). C-SSRS scores were significantly lower in the polytherapy group at Week 8 newline(p=0.011). newlineConclusion newlineEscitalopram demonstrated