Clinical Validation Study for EDIT-B Test: an Aid for Differential Diagnosis of Bipolar Disorder, Based on RNA Editing Blood Biomarkers
Trial ID: NCT05603819
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2022-06-29
Completion date: 2024-09-30
Sponsor: Alcediag
Collaborators: Hospital Clinic of Barcelona; Fundacion Clinic per a la Recerca Biomédica; Region Capital Denmark; GHU Paris Psychiatry & Neurosciences; Parc Sanitari Sant Joan de Déu; Fundació Sant Joan de Déu; Synlab Italie
Conditions: Bipolar Disorder; Major Depressive Disorder
Interventions: EDIT-B
Locations: The Capital Region of Denmark; GHU Paris Psychiatrie & Neurosciences; Parc Sanitari Sant Joan de Déu; Hospital Clínic de Barcelona
Countries: Denmark; France; Spain; Spain
Enrollment: 418
Age range: 18 Years - 80 Years
Sex: ALL

Summary:
Differentiation between major depressive disorder (MDD) and bipolar disorder (BD) as soon as possible in the patient journey represents a major clinical issue. When the patient is in a depressive phase, the symptoms are similar between the two pathologies and the current clinical scales fail in distinguishing them. Physicians often report this difficulty and as a consequence, the mean time from onset to bipolar disorder diagnosis is currently 7.5 years. These diagnostic delays and misdiagnosis lead to damaging consequences for patients and their loved ones: worsening of symptoms, comorbidities, suicide risk and inadequate care resulting in severe impairment in social and occupational functioning. Faced with these high expectations for accurate diagnostic methods for an earlier management of psychiatric patients, the combination of relevant clinical features and biomarkers could stand for a solution, leading to a personalised approach in patients with mood disorders.

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.

Eligibility criteria:
Inclusion Criteria:

1. Signed informed consent.
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:

1. MDD patients with first degree family history of bipolar disorder
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

Outcomes:
Diagnostic performances of EDIT-B signatures on MDD vs. BD differentiation in patients with depression.