Sertraline for the Treatment of Major Depressive Disorder in the US: Effectiveness and Acceptability in Real-World Practice

Abstract

Background: Major depressive disorder (MDD) is a serious mental illness and leading cause of disability. MDD is highly comorbid with physical illnesses such as cardiovascular disease (CVD) and diabetes mellitus (DM). Sertraline, a selective serotonin reuptake inhibitor, is proven effective and well-tolerated in clinical trials, and is recommended among first-line treatment options for MDD. Methods: This study explored the effectiveness and acceptability of sertraline in real-world clinical practice, utilizing electronic health record-derived, de-identified data from NeuroBlu Data in the USA. All-cause sertraline discontinuation was the main outcome, with change in Clinical Global Impressions Severity (CGI-S) serving as a secondary outcome. Results: All-cause discontinuation was assessed in 2948 patients treated with sertraline for MDD (702 comorbid with CVD and 280 with DM). The cumulative discontinuation rates at 2- and 3-month follow-up time points were 16.9% and 24.8%, respectively. No significant differences were observed between males and females or those with and without CVD or DM. Change in CGI-S was assessed in 713 patients who had data for one or more follow-up assessments conducted between 2 to 24 months after sertraline prescription. About 9% to 17% of patients demonstrated clinically substantial improvement in CGI-S (decrease by ≥2) across follow-up time points, while 74% to 88% showed little or no change. A sensitivity analysis showed clinically meaningful improvement in CGI-S (decrease by ≥1) in 19% to 36% of patients, with 54% to 69% showing no change. Patients with greater illness severity at baseline were more likely to experience improvement. Conclusion: This study demonstrates that all-cause discontinuation rates in routine practice were consistent with clinical trials indicating comparable sertraline treatment acceptability. The findings add to the body of evidence on real-world effectiveness and clinical utility of sertraline in patients with MDD with or without comorbid chronic medical illnesses like CVD and DM.