Abstract
BACKGROUND: 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.