RecruitingNot ApplicableNCT07031817

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


Sponsor

University Hospital, Montpellier

Enrollment

623 participants

Start Date

Sep 30, 2025

Study Type

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a blood test combined with a mood questionnaire can help accurately diagnose bipolar disorder — a condition often mistaken for regular depression. **You may be eligible if...** - You are between 18 and 65 years old (any gender identity) - You have been diagnosed with moderate to severe depression and are eligible to start antidepressant treatment **You may NOT be eligible if...** - You are under guardianship or legal protection - You have been diagnosed with schizophrenia - You have taken certain psychiatric medications in the 5 days before the study (or 21 days for specific drugs like fluoxetine or aripiprazole) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTVenous 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.

OTHERStandardized 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.


Locations(1)

CHU de Montpellier

Montpellier, France

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NCT07031817


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