Table 1 EDIT-B study summary
Study title | Clinical validation study for EDIT-B test: an aid for differential diagnosis of bipolar disorder, based on RNA editing blood biomarkers |
Short title | EDIT-B |
Study participants | In- and out adult patients between 18 and 80Â years old diagnosed with bipolar disorder or major depressive disorder, and currently treated for an acute major depressive episode |
Study centres | 4 centres in 3 countries (Denmark, France, Spain) |
Start date | June 2022 |
Planned end date | December 2024 |
Ethics approval and registration number | France/BRC ID: 2021-A03062-39 Denmark/Journal-nr.: H-22010899 Spain (Hospital Clinic): Reg. HCB/2022/0042 Spain (Parc Sanitari Sant Joan de Déu): C.I. PS-05-22 ClinicalTrials.gov ID: NCT05603819 |
Study objectives and methods | The objective of this study is to estimate three EDIT-B signatures in term of their external validity. For this purpose, performance of the test will be estimated by calculating for each signature its sensitivity, specificity and its accuracy to predict the diagnosis of bipolar disorder. Area under the ROC curve of each signature will be calculated. Additionally, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio and odds ratio will be calculated |