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Introduction <p>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.</p> Aim <p>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.</p> Methods and analysis <p>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&#xa0;°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.</p> Ethics and dissemination <p>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.</p> <p><i>Study registration</i>: This study has been registered on clinicaltrials.gov (NCT05603819). Registration date: 28-10-2022.</p>

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RNA editing-based biomarker blood test for the diagnosis of bipolar disorder: protocol of the EDIT-B study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年2月6日

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  • Andrea Miranda-Mendizabal,
  • Diana Vetter,
  • Juan Zambrano,
  • Jeff Zarp,
  • Victor Chavarría,
  • Anna Giménez-Palomo,
  • Meritxell Gonzalez-Campos,
  • Marc Valenti,
  • Lara Walczer Baldinazzo,
  • Sara Siddi,
  • Maurizio Ferrari,
  • Dinah Weissmann,
  • Chantal Henry,
  • Josep Maria Haro,
  • Lars Vedel Kessing,
  • Eduard Vieta

摘要

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.