Clinical Validation Study for EDIT-B Test: an Aid for Differential Diagnosis of Bipolar Disorder, Based on RNA Editing Blood Biomarkers

Recruiting

• Conditions: Bipolar Disorder; Major Depressive Disorder

• Registration Number: NCT05603819
• Lead Sponsor: Alcediag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-28
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 436

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Signed informed consent.<br><br> 2. Male or female = 18 and = 80 years of age at inclusion.<br><br> 3. MADRS = 20<br><br> 4. In- and out-patients can be recruited.<br><br> 5. Diagnosed with MDE with the MINI for DSM-5<br><br> 6. Currently treated for the MDE<br><br> 7. Diagnosed with MDD or BD with the MINI for DSM-5.<br><br> 8. For patients with BD: at least one manic or hypomanic episode<br><br> 9. For patients with MDD: at least one MDE<br><br>Exclusion Criteria:<br><br> 1. MDD patients with first degree family history of bipolar disorder<br><br> 2. YMRS > 12<br><br> 3. Pregnant women<br><br> 4. Unipolar or bipolar depression secondary to major central nervous system affections,<br> including infections in the brain, tumours of the brain, stroke, Alzheimer's<br> disease, Parkinson's disease, Multiple sclerosis, other major brain affections<br><br> 5. Schizo-affective patients<br><br>Abbrevations:<br><br>BD Bipolar Disorder DSM-5 Diagnostic and Statistical Manual of Mental disorders 5 MADRS<br>Montgomery-Asberg Depression Rating Scale MDD Major Depressive Disorder MDE Major<br>Depressive Episode MINI Mini-International Neuropsychiatric Interview YMRS Young Mania<br>Rating Scale

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic performances of EDIT-B signatures on MDD vs. BD differentiation in patients with depression.