← Eichor
Study identifier: NCT07031817 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Disorder

Condition: Bipolar Disorder (BD) · Major Depressive Episode (MDE) · Primary Care  ·  Sponsor: University Hospital, Montpellier

PhaseNA
Planned participants623
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Raoul BELZEAUX  ·  +33 0467337913  ·  raoul.belzeaux@chu-montpellier.fr

Always discuss trial participation with your own doctor first.

Locations (1)

CHU de MontpellierMontpellier, FranceRecruiting

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT07031817