Depressive Symptoms, Functional Status, and Cardiovascular Parameters in Patients with Major Depressive Disorder Undergoing Cardiac Rehabilitation While Treated with Vortioxetine: A Prospective Observational Study.

Background/

Objectives

Real-world evidence on the use of vortioxetine within cardiac rehabilitation (CR) programs among patients with major depressive disorder (MDD) remains limited. We aimed to describe the evolution of depressive symptoms, functional status, and selected cardiovascular and biometric parameters in patients with MDD undergoing CR while receiving vortioxetine in routine clinical practice.

Methods

This was a 12-week, prospective, observational study conducted at Clínica Colman (Cádiz, Spain) between July 2022 and July 2024. Adults diagnosed with MDD who were undergoing CR and receiving vortioxetine as part of routine care were included. Depressive symptoms (Hamilton Depression Rating Scale, HAM-D) and functional impairment (Sheehan Disability Scale, SDS) were assessed at baseline and at weeks 3, 7, and 12. Cardiovascular and biometric parameters were measured at baseline and at week 12. Repeated-measures ANOVA and paired t-tests were used for statistical analysis.

Results

Forty-nine patients were included (mean age 65.6 years; 41% women). Over the 12-week follow-up period, mean HAM-D and SDS scores decreased over time (both p < 0.001). Changes were also observed in VO2 max, body weight, body mass index, and waist circumference (all p < 0.05). Left ventricular ejection fraction, blood pressure, and QTc interval showed no relevant variation during follow-up. Mild adverse effects were reported in 6.1% of patients.

Conclusions

In patients with MDD and undergoing CR while receiving vortioxetine, longitudinal changes were observed in psychological, functional, and selected cardiovascular measures. These real-world data describe clinical trajectories within integrated rehabilitation settings and provide hypothesis-generating evidence for future controlled studies.