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.
Single group
Venous blood sample for measuring blood biomarkers related to bipolar disorder
Diagnostic testParticipants will undergo a venous blood draw for analysis by an investigational composite medical device designed to aid in the diagnosis of bipolar disorder. The device analyzes specific circulating biomarkers hypothesized to differ between patients with bipolar disorder and those with unipolar depression.
Standardized psychiatric assessment tools
Other interventionParticipants will complete validated psychiatric screening tools used as reference standards to evaluate bipolar disorder, including the Mood Disorder Questionnaire (MDQ). These tools will be used to compare their diagnostic output with that of the investigational blood test.
Sensitivity and specificity of the composite medical device, using the full clinical evaluation as a reference
To assess the sensitivity and specificity of a composite diagnostic device using a biomarker-based algorithm (IL-6, IL-10, IL-15, IL-27, CXCL10), combined with clinical data (age, depression severity via QIDS, psychotropic treatment), to identify bipolar disorder in primary care patients with a depressive episode. The algorithm, developed by the investigators, will be implemented in the eCRF and classify patients as bipolar, non-bipolar, or in a grey zone. The reference diagnosis will be established by an expert psychiatrist using the MINI interview and a full clinical evaluation, including medical history and patient records, following standardized procedures for optimal diagnostic accuracy.
Area under the curve
To determine the area under the curve (AUC) of the composite medical device for the diagnosis of bipolar disorder in patients presenting with a characterised depressive episode in primary care with a clinical assessment by an expert psychiatrist as reference.
Negative predictive value
To determine the negative predictive value (NPV) of the composite medical device for the diagnosis of bipolar disorder in patients presenting with a characterised depressive episode in primary care with a clinical assessment by an expert psychiatrist as reference.
Positive predictive value
To determine the positive predictive value (PPV) of the composite medical device for the diagnosis of bipolar disorder in patients presenting with a characterised depressive episode in primary care with a clinical assessment by an expert psychiatrist as reference.
Occurence of hypomanic symptoms
The occurrence of hypomanic symptoms will be determined by comparing the patient's responses to the MDQ at visit n°3 and visit n°5. Any positive response at visit n°5 to a question to which the response was negative at visit n°3 will indicate the occurrence of hypomanic symptoms between visit n°3 and visit n°5; if the number of hypomanic symptoms is greater at visit n°5 than at visit n°3, the patient will be classified in the 'new hypomanic symptoms' group.
Click on the lead sponsor to view all of their trials.
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
