Safety and effectiveness of vortioxetine in patients with major depressive disorder in a real-life clinical setting in India: results from an interventional, flexible-dose study.

Publication date: Aug 07, 2024

Vortioxetine has demonstrated safety and efficacy in improving symptoms of major depressive disorder (MDD), including overall functioning in real-world settings. This is the first study in a real-life clinical setting in India to evaluate effectiveness and safety of vortioxetine in patients with MDD. This interventional, open-label study consisted of a 12-week treatment period with flexible doses of vortioxetine (5-20 mg/day) in adult patients (aged 18-65 years) with a confirmed MDD diagnosis. Effectiveness outcomes included change from baseline to week 12 in Patient Health Questionnaire-9 (PHQ-9) and Clinical Global Impression-Severity (CGI-S) scores, along with CGI-Improvement (CGI-I) scores at week 12, using a mixed model for repeated measures. Adverse events (AEs) were recorded for safety outcome assessments. Of 395 patients who received vortioxetine, 42. 3% were women mean age 38. 9 years; 322 patients completed the study. Significant improvement in depressive symptoms was observed in change from baseline to week 12 least squares (LS) mean (SE) PHQ-9 total score (-9. 36 [0. 276]; p

Concepts Keywords
20mg antidepressive agents
9years effectiveness
Depressive Major depressive disorder
Effectiveness PHQ-9
Vortioxetine real-life clinical setting
safety
vortioxetine

Semantics

Type Source Name
drug DRUGBANK Vortioxetine
disease MESH major depressive disorder

Original Article

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