Noninterventional, Retrospective, Prospective, Longitudinal Cohort Study to Assess Antidepressant Treatment Patterns and Outcomes in Individuals With Major Depressive Disorder

Background: Real-world data on antidepressant (AD) treatment for major depressive disorder (MDD) in clinical practice are limited for all ADs including vortioxetine.
Methods: This 2-phase, noninterventional, retrospective, prospective, longitudinal US-based study aims to compare demographics, treatment patterns, and outcomes of patients with MDD treated with vortioxetine and other ADs. Phase 1 included 10,931 individuals aged ≥18 years from the general population after a 3-year follow-up interval. Phase 2, currently underway, aims to enroll up to 1000 participants with previously diagnosed MDD (n=500 treated with vortioxetine and n=500 with other ADs). Ad-Infer EVAL (hybrid AI expert system) will be used to conduct web-based interviews to collect data at baseline (initial interview) and 3 months (follow-up). Demographic, medical, and psychiatric data will be collected at baseline. Medication history (eg, AD treatment patterns), clinical characteristics (including symptoms of depression), clinical outcomes (ie, response and remission rates, tolerability), and other relevant data (eg, HRQoL) will be assessed during follow-up.
Results: In phase 1, the 12-month MDD prevalence was 9.5% at the initial interview and 12.1% at follow-up. During the initial interview, 52.2% reported AD treatment in the previous month, of whom 43.4% reported achieving full remission by follow-up; norepinephrine-dopamine reuptake inhibitors had the highest remission rate (61.7%). Estimated phase 2 completion is targeted for September 2024.
Conclusions: This study will provide real-world data on patient experience with MDD, including characterization of people with MDD from the general population and their burden of illness with vortioxetine compared with other ADs using the Ad-Infer EVAL system.