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

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.

Conditions

• Bipolar Disorder (BD)
• Major Depressive Episode (MDE)
• Primary Care
• Major Depression

Interventions

DIAGNOSTIC_TEST

Venous blood sample for measuring blood biomarkers related to bipolar disorder

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.

OTHER

Standardized psychiatric assessment tools

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.

Sponsors & Collaborators

• CH Béziers

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Nīmes

  collaborator OTHER

• Assistance Publique Hopitaux De Marseille

  collaborator OTHER

• University Hospital, Toulouse

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• USSAP Carcassonne

  collaborator UNKNOWN

• Ajaccio Hospital Center

  collaborator OTHER

• CH TOULON

  collaborator UNKNOWN

• CH Thuir

  collaborator UNKNOWN

• CH Montauban

  collaborator UNKNOWN

• Centre de Ressources Biologiques de Montpellier

  collaborator UNKNOWN

• Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie

  collaborator OTHER

• University Hospital, Montpellier

  lead OTHER

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-30

Primary Completion

2027-10-01

Completion

2028-07-01

Countries

• France

Study Locations