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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU de Montpellier
RECRUITING
Montpellier
Contact Information
Primary
Raoul BELZEAUX
raoul.belzeaux@chu-montpellier.fr
+33 0467337913
Time Frame
Start Date: 2025-09-30
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 623
Treatments
Experimental: Diagnostic Evaluation Arm
Participants in this arm will undergo the full diagnostic procedure under investigation. This includes :~* A blood sample collected for analysis by the investigational in vitro diagnostic device targeting biomarkers associated with bipolar disorder,~* Completion of validated psychiatric questionnaires, including the Mood Disorder Questionnaire (MDQ), used as clinical reference standards,~* Collection of sociodemographic and clinical data relevant to the psychiatric profile. This arm does not involve any therapeutic intervention. The objective is to evaluate the diagnostic concordance between the blood test and psychiatric screening tools.
Related Therapeutic Areas
Sponsors
Collaborators: CH TOULON, CH Béziers, CH Thuir, Assistance Publique Hopitaux De Marseille, University Hospital, Toulouse, Centre Hospitalier Universitaire de Nīmes, Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie, USSAP Carcassonne, Nantes University Hospital, CH Montauban, Ajaccio Hospital Center, Centre de Ressources Biologiques de Montpellier
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov