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

NARecruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

February 3, 2025

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2027

Conditions
Bipolar DisorderMajor 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."

Trial Locations (7)

Unknown

NOT_YET_RECRUITING

CH Erstein, Erstein

NOT_YET_RECRUITING

AP-HP Corentin Celton, Issy-les-Moulineaux

NOT_YET_RECRUITING

Etablissement Public de Santé Mentale (EPSM) 74, La Roche-sur-Foron

RECRUITING

Clinique Villa des Roses, Lyon

RECRUITING

Clinique Le Clos Montaigne, Montrond-les-Bains

RECRUITING

GHU Paris Psychiatrie et Neurosciences, Paris

NOT_YET_RECRUITING

Clinique Médicale de Ville d'Avray, Ville-d'Avray

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

BPIfrance

OTHER

collaborator

Synlab Holding Deutschland GmbH

INDUSTRY

collaborator

GHU Paris Psychiatrie et Neurosciences

UNKNOWN

collaborator

CH Erstein

UNKNOWN

collaborator

AP-HP Corentin-Celton

UNKNOWN

collaborator

Clinique Villa des Roses

UNKNOWN

collaborator

Clinique Le clos Montaigne

UNKNOWN

collaborator

Clinique Médicale de Ville d'Avray

UNKNOWN

collaborator

EPSM 74

UNKNOWN

lead

Alcediag

INDUSTRY