Abstract

Background: Depression is common yet under-reported disorder in the real-world setting. Although antidepressants have demonstrated superiority over placebo in clinical trials, many patients elicit a suboptimal response or relapse. Moreover, real-world data in the Indian population are limited.

Aim and Objective: This study aims to assess and compare the efficacy and safety of escitalopram in patients with newly diagnosed depression (NDD) versus relapse in India.

Materials and Methods: This is an ongoing real-world observational study of escitalopram in patients with NDD or relapse in India. Primary endpoint was change in mean Hamilton Depression Rating Scale (HAM-D 17) scores from baseline to week 8. Secondary endpoints included assessment of response/remission rates, Clinical Global Impression (CGI) scores, quality of life, suicidal tendency, and safety.

Results: Data for the first 50 patients demonstrated a significant reduction in HAM-D 17 scores at week 8 (P < 0.001); patients with NDD (n = 38) elicited significantly higher improvement compared with relapsed patients (n = 12) (P < 0.001). Although patients with NDD had significantly poorer CGI (P < 0.001) and quality of life (anxiety/depression subscale) (P < 0.05) scores at baseline, an improvement was observed in both scales with no significant difference between the groups at week 8. Suicidal tendency reduced from 83.3% to 0%. No new safety concerns were observed in the study.

Conclusion: Escitalopram demonstrated efficacy and was well tolerated in both, NDD and relapsed patients in the real-world setting in India, with better results achieved by NDD patients. However, more studies are required to confirm the difference across the groups.

Key words: Depression; India; Major Depressive Disorder; Observational Study; Real World; Relapse