Evaluation of the Impact of the EDIT-Bae Blood Test on Patients with Major Depressive Episode Clinical Utility and Economic Aspects

What this Trial Is About

Depression is a common mental disorder affecting a significant portion of the population and is linked to increased risks, including suicidal behavior. Major Depressive Episodes MDEs can occur in Major Depressive Disorder MDD or bipolar disorder BD, which affects about 2 of the global population. Bipolar disorder involves episodes of mania or hypomania alternating with depression, and its diagnosis is often delayed by around 7 years, increasing health risks. This research evaluates the clinical and economic impact of the EDIT-Bae blood test, which helps differentiate between bipolar disorder and major depression to improve patient management. The study compares two groups of patients experiencing moderate to severe MDEs one group where doctors use the EDIT-Bae test results to guide treatment, and a control group where the test is done but results are not shared until the study ends. EDIT-Bae involves a blood sample analyzed with advanced RNA sequencing and AI algorithms to support diagnosis. The study plans to recruit 450 patients over 24 months, with each participant involved for 6 months and attending 4 study visits. Participants will be assessed for improvement in depressive symptoms, measured between the start and approximately 15-16 weeks into the study. The research includes clinical evaluations and monitoring over the 6-month period. The study aims to track how the test impacts treatment decisions and patient outcomes, along with health economic effects, to better understand its role in managing bipolar and major depressive disorders.

Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects