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The Real-Life Effectiveness of Vortioxetine in Depression (RELIEVE) study was undertaken to demonstrate the effectiveness and safety of vortioxetine for the treatment of MDD in routine clinical practice.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>RELIEVE was a 24-week, observational, prospective cohort study in outpatients with MDD initiating treatment with vortioxetine at their physician's discretion in routine care settings in Canada, France, Italy, and the USA (NCT03555136). The primary study outcome was patient functioning assessed by the Sheehan Disability Scale (SDS). Secondary outcomes included depression severity [9-item Patient Health Questionnaire (PHQ-9)], cognitive symptoms [5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5)], and cognitive performance [Digit Symbol Substitution Test (DSST)]. Mixed models of repeated measures were used to assess change from baseline at week 24, adjusted for relevant confounders.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 737 patients were eligible for inclusion in the full analysis set. Most patients (73.7%) reported at least one comorbid medical condition, 56.0% had comorbid anxiety and 24.4% had comorbid generalized anxiety disorder. Improvement in least-squares (LS) mean SDS score from baseline to week 24 was 8.7 points. LS mean PHQ-9, PDQ-D-5 and DSST scores improved by 7.4, 4.6, and 6.2 points, respectively. Adverse events were observed in 21.2% of patients [most commonly, nausea (8.2% of patients)].<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>These results demonstrate the effectiveness and tolerability of vortioxetine for the treatment of MDD in a large and heterogeneous patient population representative of that encountered in routine clinical practice.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fpsyt.2022.824831","type":"journal-article","created":{"date-parts":[[2022,3,9]],"date-time":"2022-03-09T05:27:06Z","timestamp":1646803626000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":36,"title":["Effectiveness of Vortioxetine in Patients With Major Depressive Disorder in Real-World Clinical Practice: Results of the RELIEVE Study"],"prefix":"10.3389","volume":"13","author":[{"given":"Gregory W.","family":"Mattingly","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hongye","family":"Ren","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael Cronquist","family":"Christensen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin A.","family":"Katzman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mircea","family":"Polosan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenneth","family":"Simonsen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lene","family":"Hammer-Helmich","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2022,3,9]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"1789","DOI":"10.1016\/S0140-6736(18)32279-7","article-title":"Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017","volume":"392","year":"2018","journal-title":"Lancet."},{"key":"B2","first-page":"142","article-title":"Canadian Network for Mood and Anxiety Treatments (CANMAT) consensus recommendations for functional outcomes in major depressive disorder","volume":"27","author":"Lam","year":"2015","journal-title":"Ann Clin Psychiatry."},{"key":"B3","doi-asserted-by":"publisher","first-page":"160","DOI":"10.1177\/2040622316639769","article-title":"Patient-reported functioning in major depressive disorder","volume":"7","author":"IsHak","year":"2016","journal-title":"Ther Adv Chronic Dis."},{"key":"B4","doi-asserted-by":"publisher","first-page":"59","DOI":"10.1016\/j.jad.2013.05.048","article-title":"Predicting relapse in major depressive disorder using patient-reported outcomes of depressive symptom severity, functioning, and quality of life in the Individual Burden of Illness Index for Depression (IBI-D)","volume":"151","author":"IsHak","year":"2013","journal-title":"J Affect Disord."},{"key":"B5","doi-asserted-by":"publisher","first-page":"e1","DOI":"10.4088\/PCC.15r01926","article-title":"Functional recovery in major depressive disorder: focus on early optimized treatment","volume":"18","author":"Habert","year":"2016","journal-title":"Prim Care Companion CNS Disord."},{"key":"B6","doi-asserted-by":"publisher","first-page":"510","DOI":"10.1177\/0706743716659416","article-title":"Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 clinical guidelines for the management of adults with major depressive disorder: section 1. 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