TY - JOUR
T1 - RNA editing-based biomarker blood test for the diagnosis of bipolar disorder
T2 - protocol of the EDIT-B study
AU - Miranda-Mendizabal, Andrea
AU - Vetter, Diana
AU - Zambrano, Juan
AU - Zarp, Jeff
AU - Chavarría, Victor
AU - Giménez-Palomo, Anna
AU - Gonzalez-Campos, Meritxell
AU - Valenti, Marc
AU - Baldinazzo, Lara Walczer
AU - Siddi, Sara
AU - Ferrari, Maurizio
AU - Weissmann, Dinah
AU - Henry, Chantal
AU - Haro, Josep Maria
AU - Kessing, Lars Vedel
AU - Vieta, Eduard
N1 - © 2025. The Author(s).
PY - 2025
Y1 - 2025
N2 - INTRODUCTION: Misdiagnosis of bipolar disorder (BD) can lead to ineffective treatment, increased risk of manic episodes, and increased severity. Objective diagnostic tests or precise tools to diagnose BD and distinguish it from major depressive disorder (MDD) in depressed patients are lacking.AIM: To assess the external diagnostic validity of a blood-based test using an RNA epigenetic signature for the differential diagnosis of BD versus MDD in patients with depression.METHODS AND ANALYSIS: Multicentre cross-sectional study including an adult sample of inpatients or outpatients diagnosed with BD or MDD, currently treated for a major depressive episode. A structured diagnostic interview based on validated scales will be conducted. Sociodemographic variables, clinical history, toxic consumption, current treatment and quality of life will be assessed. Blood samples will be obtained and stored at -80 °C until RNA sequencing analysis. The EDIT-B is a blood-based test that combines RNA editing biomarkers and individual data (e.g., age, sex, and tobacco consumption). The clinical validation performance of the EDIT-B will be evaluated using the area under the curve, sensitivity, specificity, positive and negative predictive values, and likelihood ratios.ETHICS AND DISSEMINATION: The principles of the Declaration of Helsinki 2013, precision psychiatry research and good clinical practice will be followed. The Research Ethics Committees of the participating centres approved the study. Participants will receive an information sheet and must sign the informed consent before the interview. Participants' data will be pseudonymized at the research sites. Any publication will use fully anonymized data. Publications with the final study results will be disseminated in international peer-reviewed journals and presented at international conferences.STUDY REGISTRATION: This study has been registered on clinicaltrials.gov (NCT05603819). Registration date: 28-10-2022.
AB - INTRODUCTION: Misdiagnosis of bipolar disorder (BD) can lead to ineffective treatment, increased risk of manic episodes, and increased severity. Objective diagnostic tests or precise tools to diagnose BD and distinguish it from major depressive disorder (MDD) in depressed patients are lacking.AIM: To assess the external diagnostic validity of a blood-based test using an RNA epigenetic signature for the differential diagnosis of BD versus MDD in patients with depression.METHODS AND ANALYSIS: Multicentre cross-sectional study including an adult sample of inpatients or outpatients diagnosed with BD or MDD, currently treated for a major depressive episode. A structured diagnostic interview based on validated scales will be conducted. Sociodemographic variables, clinical history, toxic consumption, current treatment and quality of life will be assessed. Blood samples will be obtained and stored at -80 °C until RNA sequencing analysis. The EDIT-B is a blood-based test that combines RNA editing biomarkers and individual data (e.g., age, sex, and tobacco consumption). The clinical validation performance of the EDIT-B will be evaluated using the area under the curve, sensitivity, specificity, positive and negative predictive values, and likelihood ratios.ETHICS AND DISSEMINATION: The principles of the Declaration of Helsinki 2013, precision psychiatry research and good clinical practice will be followed. The Research Ethics Committees of the participating centres approved the study. Participants will receive an information sheet and must sign the informed consent before the interview. Participants' data will be pseudonymized at the research sites. Any publication will use fully anonymized data. Publications with the final study results will be disseminated in international peer-reviewed journals and presented at international conferences.STUDY REGISTRATION: This study has been registered on clinicaltrials.gov (NCT05603819). Registration date: 28-10-2022.
U2 - 10.1186/s12991-024-00544-8
DO - 10.1186/s12991-024-00544-8
M3 - Journal article
C2 - 39915772
VL - 24
JO - Annals of General Psychiatry
JF - Annals of General Psychiatry
SN - 1744-859X
M1 - 7
ER -