Clinical trial NCT05603819: Clinical Validation Study for EDIT-B Test: an Aid for Differential Diagnosis of Bipolar Disorder, Based on RNA Editing Blood Biomarkers
Official title: Clinical Validation Study for EDIT-B Test: an Aid for Differential Diagnosis of Bipolar Disorder, Based on RNA Editing Blood Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Major Depressive Disorder
Lead sponsor: Alcediag
Sponsor class: INDUSTRY
Collaborators: name: Hospital Clinic of Barcelona
name: Fundacion Clinic per a la Recerca Biomédica
name: The Capital Region of Denmark
name: GHU Paris Psychiatry & Neurosciences
name: Parc Sanitari Sant Joan de Déu
name: Fundació Sant Joan de Déu
name: Synlab Italie
First posted: 2022-11-03
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with depression meeting the MDE criteria in DSM-5 using the MINI will be eligible for the study. They can be in- and out-patients for each clinical center.

Brief 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

Primary outcomes:
measure: Diagnostic performances of EDIT-B signatures on MDD vs. BD differentiation in patients with depression.
timeFrame: Specimen collection needed for evaluation of diagnostic performances: 1 day (= 1 visit).
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Capital Region of Denmark
city: Paris
country: France
facility: GHU Paris Psychiatrie & Neurosciences
city: Sant Boi De Llobregat
country: Spain
facility: Parc Sanitari Sant Joan de Déu
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Eduard Vieta
role: PRINCIPAL_INVESTIGATOR
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