Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects

Summary

Depression is one of the most common mental disorders, affecting nearly 10% of men and 20% of women worldwide. It is associated with a significant increase in mortality, mainly due to suicidal behavior. The Diagnostic and Statistical Manual of Mental Disorders (DSM) defines a Major Depressive Episode (MDE) by a combination of at least five different symptoms, with at least one depressed mood or loss of interest. MDEs can occur in isolation or as part of Major Depressive Disorder (MDD) or bipolar disorder (BD). Bipolar disorders affect 2% of the world's population and are defined by episodes of mania (Type I BD) or hypomania (Type II BD) alternating with episodes of depression and periods of remission.

Depression occurring whether in the context of BD or MDD is defined with the same clinical criteria. However, the pharmacological treatments are different in the two groups. In particular, antidepressants prescribed without a thymoregulator in bipolar patients can lead to a worsening of the episode, favoring suicidal behavior or a manic turn.

The average interval between the onset of BD symptoms and appropriate diagnosis is estimated to be approximately 7 years, which delays appropriate management and treatment and increases the risk of suicide.

Biological markers able to differentiate between the different types of depression were lacking before the advent of EDIT-B®; one of the main objectives of this research is to measure the clinical impact of the use of EDIT-B® in the short and medium term on the management of patients with BD and major depression. The health economic aspect will also be considered.

In total, 450 patients in two different groups (EDIT-B® group and control group) will be recruited over a study timeline of 24 months. Study participation is over 6 months with 4 visits.

Conditions

• Bipolar Disorder
• Major Depressive Disorder

Interventions

DIAGNOSTIC_TEST

EDIT-B test

EDIT-B® is the first blood test for the differential diagnosis of bipolar disorder (BD) and major depression. It consists of a biological analysis (including targeted RNA sequencing) followed by a software interpretation thanks to an algorithm developed with AI. The test is CE marked, clinically validated on two independent cohorts and shows an excellent performance with a sensitivity and specificity of more than 80%. For performing the test, a blood sample of 2.5 ml will be drawn using PAXgene™ Blood RNA tubes (Becton Dickinson, UK) according to the manufacturer's instructions. The objective of EDIT-B® is to reduce the time to diagnosis of BD, which is currently 7 years on average. This will improve the patient pathway, thanks to faster access to appropriate care - whether for unipolar or bipolar patients - with a major medical, social and financial impact.

DIAGNOSTIC_TEST

EDIT-B test (without giving result)

EDIT-B® is the first blood test for the differential diagnosis of bipolar disorder (BD) and major depression. It consists of a biological analysis (including targeted RNA sequencing) followed by a software interpretation thanks to an algorithm developed with AI. The test is CE marked, clinically validated on two independent cohorts and shows an excellent performance with a sensitivity and specificity of more than 80%. For performing the test, a blood sample of 2.5 ml will be drawn using PAXgene™ Blood RNA tubes (Becton Dickinson, UK) according to the manufacturer's instructions. THE RESULT OF THE TEST WILL NOT BE GIVEN TO THE PARTICIPANT BEFORE THE END OF THE STUDY. The objective of EDIT-B® is to reduce the time to diagnosis of BD, which is currently 7 years on average. This will improve the patient pathway, thanks to faster access to appropriate care - whether for unipolar or bipolar patients - with a major medical, social and financial impact.

Sponsors & Collaborators

• BPIfrance

  collaborator OTHER

• Synlab Holding Deutschland GmbH

  collaborator INDUSTRY

• GHU Paris Psychiatrie et Neurosciences

  collaborator UNKNOWN

• CH Erstein

  collaborator UNKNOWN

• AP-HP Corentin-Celton

  collaborator UNKNOWN

• Clinique Villa des Roses

  collaborator UNKNOWN

• Clinique Le clos Montaigne

  collaborator UNKNOWN

• Clinique Médicale de Ville d'Avray

  collaborator UNKNOWN

• EPSM 74

  collaborator UNKNOWN

• Alcediag

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-03

Primary Completion

2026-05-31

Completion

2027-05-31

Countries

• France

Study Locations