The goal of this interventional clinical trial is to assess the diagnostic performance of a composite diagnostic medical devise based on blood-based in vitro diagnostic device and Mood Disorder Questionnaire (MDQ) in identifying bipolar disorder among adult patients presenting with a current major depressive episode in primary care. The study will compare the results of the medical device diagnostic test to those of standardized psychiatric clinical evaluation, to evaluate its sensitivity, specificity, and overall clinical utility.
The main research questions are :
* Can the investigational medical device accurately distinguish bipolar disorder from unipolar depression ? * How does its diagnostic accuracy compare with validated psychiatric questionnaires commonly used in clinical practice ?
Participants will :
* Provide a blood sample for biomarker analysis using the investigational diagnostic device. * Complete a few validated psychiatric assessment tools (e.g., MDQ, MINI). * Share sociodemographic and clinical data relevant to psychiatric evaluation.
Cis man, cis woman, trans man, trans woman or non-binary,
Aged 18 to 65 years old,
Meets the DSM-5 criteria for the diagnosis of moderate to severe EDC and is eligible for antidepressant treatment.
Patients under guardianship or trusteeship,
Participants will have the right to withdraw their consent at any time for any reason whatsoever without any prejudice to them,
The investigator may prematurely exclude a subject from the study, in agreement with the sponsor, if the subject presents one or more exclusion criteria,
Diagnosis of schizophrenia during follow-up or any other diagnosis that would lead to a change in the initial EDC diagnosis,
Any condition or situation which, in the opinion of the investigator, would be incompatible with the continuation of the study or which would lead to a bias in the management of the data.
University Hospital, Montpellier
Lead sponsor
CH Béziers
Collaborator
Centre Hospitalier Universitaire de Nīmes
Collaborator
Assistance Publique Hopitaux De Marseille
Collaborator
University Hospital, Toulouse
Collaborator
Nantes University Hospital
Collaborator
USSAP Carcassonne
Collaborator
Ajaccio Hospital Center
Collaborator
CH TOULON
Collaborator
CH Thuir
Collaborator
CH Montauban
Collaborator
Centre de Ressources Biologiques de Montpellier
Collaborator
Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie
Collaborator