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

Christoph U Correll,1– 6 Pradeep Purushottamahanti,7 Kannan Subramaniam,8 Bituparna Bayan,9 Joseph P Cook,10 Emily OC Palmer,11 Joannas Yeow,12 Nadia Lipunova11 1Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, USA; 2Department of Psychiatry and Molecular Medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA; 3Center for Psychiatric Neuroscience, Feinstein Institute for Medical Research, Manhasset, NY, USA; 4Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin, Germany; 5German Center for Mental Health (DZPG), Partner Site Berlin, Berlin, Germany; 6Einstein Center for Population Diversity (ECPD), Berlin, Germany; 7Global Medical Affairs, Viatris Inc., Bangalore, India; 8Global Medical Affairs, Viatris Inc., Auckland, New Zealand; 9Real World Data and Analytics, Viatris Inc., Bangalore, India; 10Real World Data and Analytics, Viatris Inc., Canonsburg, PA, USA; 11Real World Evidence, Holmusk Technologies Inc., London, UK; 12Real World Evidence, Holmusk Technologies Inc., Singapore, SingaporeCorrespondence: Christoph U Correll, Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Campus Virchow, Augustenburger Platz 1, Berlin, 13353, Germany, Tel +49/30-450-566202, Fax +49/30-450-566921, Email christoph.correll@charite.deBackground: 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.Plain Language Summary: 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.Keywords: antidepressants, Clinical Global Impression – Severity, major depressive disorder, real-world evidence, sertraline, United States