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.
Keywords: Clinical Global Impression – Severity; United States; antidepressants; major depressive disorder; real-world evidence; sertraline.
Major depressive disorder (MDD) is a serious health condition affecting many people worldwide. People with MDD often have other health problems such as heart disease and diabetes. Sertraline is a commonly used treatment for MDD, which may be prescribed in the presence of these other health issues. This study used the medical records of about 3000 adults with MDD living in the US to explore whether they benefitted from treatment with sertraline. The main way this was measured was using “all-cause discontinuation rate”. This looks at how many people stopped taking sertraline for any reason and is considered a measure of how well the medicine worked and how it was tolerated. Most people continued taking sertraline during the study period, with 17% of people stopping it after 2 months; a further 8% had stopped it at 3 months. People with MDD and other illnesses like heart disease or diabetes were just as likely to keep taking sertraline as those without. The overall severity of depressive illness was not high in most people studied when they started taking sertraline and only small changes were observed with treatment. Patients with more severe illness were more likely to improve when treated with sertraline. Overall, patients with MDD in this study responded to treatment with sertraline. However, when studies use data from medical records that have been collected for other reasons, more studies are needed to confirm the results.
© 2026 Correll et al.