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

IF 3.6 3区医学 Q1 PSYCHIATRY

Annals of General Psychiatry Pub Date : 2025-02-06 DOI:10.1186/s12991-024-00544-8

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

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引用次数: 0

Abstract

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.

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基于RNA编辑的双相情感障碍诊断生物标志物血液检测：EDIT-B研究方案

导读：双相情感障碍（BD）的误诊会导致治疗无效，增加躁狂发作的风险，并增加严重程度。缺乏客观的诊断测试或精确的工具来诊断抑郁症患者的双相障碍并将其与重度抑郁症（MDD）区分开来。目的：评估使用RNA表观遗传标记的基于血液的测试对抑郁症患者BD与MDD的鉴别诊断的外部诊断有效性。方法和分析：多中心横断面研究，包括诊断为双相障碍或重度抑郁症的住院或门诊成年患者样本，目前正在接受重度抑郁症发作治疗。将进行基于有效量表的结构化诊断访谈。将评估社会人口学变量、临床病史、毒性消费、当前治疗和生活质量。采集血样并保存在-80°C，直至RNA测序分析。EDIT-B是一种基于血液的检测，结合了RNA编辑生物标志物和个人数据（如年龄、性别和烟草消费）。将使用曲线下面积、敏感性、特异性、阳性和阴性预测值以及似然比来评估EDIT-B的临床验证性能。伦理和传播：遵循2013年赫尔辛基宣言、精确精神病学研究和良好临床实践的原则。参与中心的研究伦理委员会批准了这项研究。参与者将收到一份信息表，并必须在访谈前签署知情同意书。参与者的数据将在研究现场被假名化。任何出版物都将使用完全匿名的数据。载有最后研究结果的出版物将在国际同行评议的期刊上散发，并在国际会议上发表。研究注册：本研究已在clinicaltrials.gov （NCT05603819）上注册。报名日期：2022年10月28日。

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来源期刊

Annals of General Psychiatry PSYCHIATRY-

CiteScore

6.60

自引率

2.70%

发文量

审稿时长

>12 weeks

期刊介绍： Annals of General Psychiatry considers manuscripts on all aspects of psychiatry, including neuroscience and psychological medicine. Both basic and clinical neuroscience contributions are encouraged. Annals of General Psychiatry emphasizes a biopsychosocial approach to illness and health and strongly supports and follows the principles of evidence-based medicine. As an open access journal, Annals of General Psychiatry facilitates the worldwide distribution of high quality psychiatry and mental health research. The journal considers submissions on a wide range of topics including, but not limited to, psychopharmacology, forensic psychiatry, psychotic disorders, psychiatric genetics, and mood and anxiety disorders.