Clinical Validation Study for EDIT-B Test: an Aid for Differential Diagnosis of Bipolar Disorder, Based on RNA Editing Blood Biomarkers
NCT ID: NCT05603819
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
418 participants
OBSERVATIONAL
2022-06-29
2024-09-30
Brief Summary
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In a first clinical discovery study, a panel of RNA biomarkers in the blood of patients with a major depressive episode (MDE) has been identified, allowing to differentiate bipolar disorder from MDD (unipolar depression). These biomarkers are based on RNA modifications, namely RNA editing, that could be identified using molecular biology, NGS and artificial intelligence. This panel constitutes EDIT-B test, which is based on Alcediag's proprietary and patented biomarkers and algorithms.
The present study aims to validate the biomarker signatures proposed by Alcediag by measuring the association between the modifications of the RNA editing and major depressive disorder/ bipolar disorder diagnosis, in patients with a MDE in real-life setting pilot centres.
Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Bipolar disorder
Patients with depression suffering from bipolar disorder.
EDIT-B
To perform EDIT-B test, questionnaires and 2x0.5 mL whole blood are collected from each patient.
Major depressive disorder
Patients with depression suffering from major depressive disorder.
EDIT-B
To perform EDIT-B test, questionnaires and 2x0.5 mL whole blood are collected from each patient.
Interventions
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EDIT-B
To perform EDIT-B test, questionnaires and 2x0.5 mL whole blood are collected from each patient.
Eligibility Criteria
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Inclusion Criteria
2. Male or female ≥ 18 and ≤ 80 years of age at inclusion.
3. MADRS ≥ 20
4. In- and out-patients can be recruited.
5. Diagnosed with MDE with the MINI for DSM-5
6. Currently treated for the MDE
7. Diagnosed with MDD or BD with the MINI for DSM-5.
8. For patients with BD: at least one manic or hypomanic episode
9. For patients with MDD: at least one MDE
Exclusion Criteria
2. YMRS \> 12
3. Pregnant women
4. Unipolar or bipolar depression secondary to major central nervous system affections, including infections in the brain, tumours of the brain, stroke, Alzheimer's disease, Parkinson's disease, Multiple sclerosis, other major brain affections
5. Schizo-affective patients
Abbrevations:
BD Bipolar Disorder DSM-5 Diagnostic and Statistical Manual of Mental disorders 5 MADRS Montgomery-Asberg Depression Rating Scale MDD Major Depressive Disorder MDE Major Depressive Episode MINI Mini-International Neuropsychiatric Interview YMRS Young Mania Rating Scale
18 Years
80 Years
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Fundacion Clinic per a la Recerca Biomédica
OTHER
Region Capital Denmark
OTHER
GHU Paris Psychiatry & Neurosciences
OTHER
Parc Sanitari Sant Joan de Déu
OTHER
Fundació Sant Joan de Déu
OTHER
Synlab Italie
UNKNOWN
Alcediag
INDUSTRY
Responsible Party
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Principal Investigators
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Eduard Vieta
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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The Capital Region of Denmark
Copenhagen, , Denmark
GHU Paris Psychiatrie & Neurosciences
Paris, , France
Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Countries
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References
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Other Identifiers
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EDIT-B
Identifier Type: -
Identifier Source: org_study_id