RNA editing-based biomarker blood test for the diagnosis of bipolar disorder: protocol of the EDIT-B study
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 lackin...
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| Format: | Article |
| Language: | English |
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BMC
2025-02-01
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| Series: | Annals of General Psychiatry |
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| Online Access: | https://doi.org/10.1186/s12991-024-00544-8 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Andrea Miranda-Mendizabal |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-7ff5ebefd1574c8bbb8ff765030c5e69 |
| institution | Kabale University |
| issn | 1744-859X |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Annals of General Psychiatry |
| spelling | doaj-art-7ff5ebefd1574c8bbb8ff765030c5e692025-02-09T12:48:55ZengBMCAnnals of General Psychiatry1744-859X2025-02-0124111310.1186/s12991-024-00544-8RNA editing-based biomarker blood test for the diagnosis of bipolar disorder: protocol of the EDIT-B studyAndrea Miranda-Mendizabal0Diana Vetter1Juan Zambrano2Jeff Zarp3Victor Chavarría4Anna Giménez-Palomo5Meritxell Gonzalez-Campos6Marc Valenti7Lara Walczer Baldinazzo8Sara Siddi9Maurizio Ferrari10Dinah Weissmann11Chantal Henry12Josep Maria Haro13Lars Vedel Kessing14Eduard Vieta15Impact and Prevention of Mental Disorders Research Group, Sant Joan de Déu Research InstitutALCEDIAG/Sys2Diag, CNRS UMR 9005GHU Psychiatrie & NeurosciencesCopenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre CopenhagenImpact and Prevention of Mental Disorders Research Group, Sant Joan de Déu Research InstitutMental Health Networking Biomedical Research Centre (CIBERSAM)Mental Health Networking Biomedical Research Centre (CIBERSAM)Mental Health Networking Biomedical Research Centre (CIBERSAM)Genetic Unit, SYNLAB ItaliaImpact and Prevention of Mental Disorders Research Group, Sant Joan de Déu Research InstitutIstituto di Ricovero e Cura a Carattere Scientifico (IRCCS), SYNLAB SDNALCEDIAG/Sys2Diag, CNRS UMR 9005GHU Psychiatrie & NeurosciencesImpact and Prevention of Mental Disorders Research Group, Sant Joan de Déu Research InstitutCopenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre CopenhagenMental Health Networking Biomedical Research Centre (CIBERSAM)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.https://doi.org/10.1186/s12991-024-00544-8Bipolar disorderRNA editingEpigeneticsDepression & mood disordersDiagnosisMachine learning |
| spellingShingle | 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 RNA editing-based biomarker blood test for the diagnosis of bipolar disorder: protocol of the EDIT-B study Annals of General Psychiatry Bipolar disorder RNA editing Epigenetics Depression & mood disorders Diagnosis Machine learning |
| title | RNA editing-based biomarker blood test for the diagnosis of bipolar disorder: protocol of the EDIT-B study |
| title_full | RNA editing-based biomarker blood test for the diagnosis of bipolar disorder: protocol of the EDIT-B study |
| title_fullStr | RNA editing-based biomarker blood test for the diagnosis of bipolar disorder: protocol of the EDIT-B study |
| title_full_unstemmed | RNA editing-based biomarker blood test for the diagnosis of bipolar disorder: protocol of the EDIT-B study |
| title_short | RNA editing-based biomarker blood test for the diagnosis of bipolar disorder: protocol of the EDIT-B study |
| title_sort | rna editing based biomarker blood test for the diagnosis of bipolar disorder protocol of the edit b study |
| topic | Bipolar disorder RNA editing Epigenetics Depression & mood disorders Diagnosis Machine learning |
| url | https://doi.org/10.1186/s12991-024-00544-8 |
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