Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Disorder
Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Disorder in Patients With a Characterized Depressive Episode in Primary Care
University Hospital, Montpellier
623 participants
Sep 30, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
Participants 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.
Participants 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.
Locations(1)
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NCT07031817