Abstract
BackgroundRandomized controlled clinical trials have shown vortioxetine to be efficacious and well tolerated for the treatment of major depressive disorder (MDD). 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.MethodsRELIEVE 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.ResultsA 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)].ConclusionsThese 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.
Highlights
Depression is a debilitating psychiatric condition and a leading cause of disability, affecting more than 264 million people worldwide [1]
Numerous studies have shown a significant association between cognitive symptoms and functioning in Major depressive disorder (MDD), which appears to be independent of the severity of mood symptoms [14–18]
This study aimed to provide novel insights into the effectiveness of vortioxetine by focusing on the patient’s own assessment of their functioning in daily life and the improvement experienced during treatment with vortioxetine using a validated and easy-to-use scale that is widely used for the assessment of overall functioning in patients with MDD
Summary
Depression is a debilitating psychiatric condition and a leading cause of disability, affecting more than 264 million people worldwide [1]. Major depressive disorder (MDD) is associated with significant impairments in psychosocial functioning [2, 3]. MDD is a multidimensional disorder that is associated with a wide range of emotional, physical, and cognitive symptoms. Data from the Sequenced Treatment Alternatives to Relieve Depression (STAR∗D) study suggest that individual symptoms differ in terms of their impact on functioning in patients with MDD, with sad mood, concentration problems, fatigue, and loss of interest (anhedonia) found to have the greatest impact [9]. Numerous studies have shown a significant association between cognitive symptoms and functioning in MDD, which appears to be independent of the severity of mood symptoms [14–18]. Randomized controlled clinical trials have shown vortioxetine to be efficacious and well tolerated for the treatment of major depressive disorder (MDD). 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
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