Evaluating an EEG-based tool for assessing acute clinical and cognitive changes in adult outpatients with MDD treated with open-label, flexible-dose vortioxetine: A pilot study

Background: Identifying neurological biomarkers to aid with diagnoses and treatment effect evaluation of mood and cognitive symptoms in major depressive disorder (MDD) is an unmet need. This study explores the Brain Network Analytics (BNA) tool, which provides information on cortical patterns compared to a healthy normative group, for improving MDD management. Methods: BNA was used to extract event-related potentials (ERPs) from high-density EEG, and its clinical utility to assess the effects of vortioxetine on depression and cognition was evaluated. Twenty-five MDD subjects (20–65 years old) with cognitive dysfunction underwent an 8-week open-label treatment using vortioxetine. ERP data, generated during cognitive tasks, were collected at pre-treatment, two weeks and eight weeks into treatment. Correlations with MDD symptoms and cognitive functioning were investigated. Exploratory analyses assessed the differences in baseline and endpoint ERP characteristics between MDD subjects and matched controls (N = 41). Results: Compared to controls, MDD subjects exhibited increased baseline latencies of P200 and P3b ERP components, which normalized at treatment endpoint. P200 and P300 in the MDD group were correlated with clinical assessments, and indicated a pro-cognitive effect of vortioxetine independent of its antidepressant effect. Limitations: This study was limited by a small sample size and lack of a placebo condition. Conclusions: Our results suggest that the application of BNA can potentially support MDD diagnosis and monitor treatment efficacy across various symptom and functional domains. Further studies are warranted to explore the role of BNA in clinical research and practice.