Effectiveness of Vortioxetine in Patients with Major Depressive Disorder in Real-World Clinical Practice: French Cohort Results from the Global RELIEVE Study

Abstract

Aim: Functional recovery is an important treatment goal in patients with major depressive disorder (MDD). The Real-Life Effectiveness of Vortioxetine in Depression (RELIEVE) study assessed the effectiveness of vortioxetine in patients with MDD receiving treatment in routine clinical care settings in France, Italy, Canada, and the United States. This paper presents the study data for the cohort enrolled in France.

Methods: RELIEVE was a 6-month, international, observational, prospective cohort study in outpatients initiating vortioxetine treatment for MDD at their physician's discretion (NCT03555136). Patients were assessed at routine clinic visits at study entry (baseline) and after 12 and 24 weeks of vortioxetine treatment. The primary study outcome was patient functioning, assessed by the Sheehan Disability Scale (SDS). Secondary outcomes included depression severity (assessed by the Patient Health Questionnaire [PHQ-9]), cognitive symptoms (assessed by the Perceived Deficits Questionnaire-Depression [PDQ-D-5]), and cognitive performance (Digit Symbol Substitution Test [DSST]). Changes from baseline to week 24 were assessed using mixed models for repeated measures, adjusted for relevant confounders. Adverse events spontaneously reported by the patient or observed by the investigator were recorded.

Results: Data are available for 184 patients in France (mean age, 50.2 years; 65.2% female). Overall, 67.9% of patients had at least one comorbidity and 46.2% reported current anxiety symptoms at baseline. Adjusted least-squares mean (standard error) change in SDS score from baseline to week 24 was -10.9 (0.6) points (P < 0.001). Respective changes for PHQ-9, PDQ-D-5 and DSST scores were -9.3 (0.5), -6.1 (0.4), and +6.9 (1.0) points (all P < 0.0001). Adverse events were reported by 29 patients (15.8%), most commonly nausea (11 patients, 6.0%).

Conclusion: Clinically relevant and sustained improvements in overall functioning, depressive symptoms, cognitive symptoms, and cognitive performance were observed in patients with MDD treated with vortioxetine for 6 months in routine clinical practice settings in France.

Keywords: effectiveness; major depressive disorder; patient functioning; real-world evidence; vortioxetine.