450
Participants
Start Date
February 3, 2025
Primary Completion Date
May 31, 2026
Study Completion Date
May 31, 2027
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."
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."
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
Lead Sponsor
BPIfrance
OTHER
Synlab Holding Deutschland GmbH
INDUSTRY
GHU Paris Psychiatrie et Neurosciences
UNKNOWN
CH Erstein
UNKNOWN
AP-HP Corentin-Celton
UNKNOWN
Clinique Villa des Roses
UNKNOWN
Clinique Le clos Montaigne
UNKNOWN
Clinique Médicale de Ville d'Avray
UNKNOWN
EPSM 74
UNKNOWN
Alcediag
INDUSTRY