Vortioxetine in the Treatment of Major Depressive Disorder Among Working Patients in Routine Clinical Practice: An Analysis of a Post-Marketing Surveillance Study in South Korea

Abstract

Seok Woo Moon,1 Jee Wook Kim,2 Do Hoon Kim,3,4 Michael Adair,5 Daniel Oudin Åström,6 Elin Heldbo Reines,5 Minah Lee,7 Gayoung Kim7 1Department of Psychiatry and Research Institute of Medical Science, Konkuk University School of Medicine, Chungju, South Korea; 2Department of Neuropsychiatry, Hallym University Dongtan Sacred Heart Hospital, Dongtan, Korea; 3Department of Psychiatry, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Korea; 4Mind-Neuromodulation Laboratory, College of Medicine, Hallym University, Chuncheon, Korea; 5Department of MSC Vortioxetine & Established Products, H. Lundbeck A/S, Valby, Denmark; 6Department of Real-World Evidence & Epidemiology, H. Lundbeck A/S, Valby, Denmark; 7Department of RA&MA, Lundbeck Korea Co., Ltd., Seoul, KoreaCorrespondence: Seok Woo Moon, Department of Psychiatry and Research Institute of Medical Science, Konkuk University School of Medicine, 82 Gugwon-daero, Chungju-si, Chungcheongbuk-do, 27376, South Korea, Tel [phone], Email [email protected]: Patients with major depressive disorder (MDD) experience depressive symptoms such as anhedonia as well as cognitive dysfunction which can subsequently impair their work performance.Purpose: To assess the effectiveness and safety of vortioxetine in working patients with MDD in South Korea.Patients and Methods: This was a subgroup analysis of a prospective, multicenter, non-interventional, non-comparative post-marketing surveillance (PMS) study. Vortioxetine-naïve patients aged > 18 years who were administered with vortioxetine were followed for up to 24± 2 weeks. Working patients were defined as those who were working or studying full- (≥ 6 hours/day) or part-time (< 6 hours/day) at baseline. Effectiveness and adverse events (AEs), assessed by both clinician and patient-reported measured, were analyzed.Results: A total of 1082 working patients (mean age: 39.56 years) were included in the subgroup analysis. Clinically significant improvements in depressive symptoms, including anhedonia, were observed over the 24 weeks of follow-up, with mean scores for the total Montgomery-Asberg Depression Rating Scale (MADRS) and anhedonia subscale both significantly decreasing from baseline by mean±standard deviation (SD) of 9.73± 9.08 and 5.37± 5.24 points, respectively, at 24 weeks (both p< 0.001 vs baseline). The vast majority of patients (80.01%) treated with vortioxetine also showed improvements in mental health symptoms over the 24 weeks, measured using the Clinical Global Impression – Improvement (CGI-I) scores. Significant improvements in cognitive symptoms were also observed over the study period, measured by the Korean Version of the Perceived Deficits Questionnaire-Depression as well as Digit Symbol Substitution Test (all p< 0.0001 from baseline at Visits 2 and 3). Vortioxetine was well tolerated in working patients, with the respective rates of any AEs and serious AEs being 18.67% and 1.20%.Conclusion: Working patients treated with vortioxetine had improvements in their depressive symptoms (including anhedonia), cognitive function and performance. Vortioxetine was found to be well tolerated in this study.Keywords: major depressive disorder, non-interventional, post-marketing surveillance, South Korea, vortioxetine, work performance

Keywords

• major depressive disorder
• non-interventional
• post-marketing surveillance
• south korea
• vortioxetine
• work performance