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RECRUITING

NCT07031817

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

623

Start Date

2025-09-30

Completion Date

2028-07-01

Last Updated

2025-10-07

Healthy Volunteers

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.

Inclusion Criteria : * 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. Non-Inclusion Criteria : * Patients under guardianship or trusteeship, * Patients with schizophrenia according to DSM-5 criteria, * Patients who have received psychotropic treatment in the 5 days prior to inclusion (or 21 days for fluoxetine or aripiprazole), with the exception of benzodiazepines and hydroxyzine at the doses and in compliance with the indications of the Marketing Authorisations, * Patients with an unstable physiological state or a serious and symptomatic medical condition in the opinion of the investigator, * Pregnant or breast-feeding patients, * Patients with a known autoimmune disease, in particular Crohn's disease or thyroiditis, or any other pathology which could, in the opinion of the investigator, modify the blood concentration of immune biomarkers, * Patients unable to give informed consent to participate in the study or who cannot be given informed information, * Patients not covered by a social security scheme, * Patients participating in another interventional study on the day of inclusion, * Patients under court protection, * Patients vaccinated less than 30 days ago, * Patients with difficulties reading, understanding or speaking French. Exclusion Criteria : * Participants will have the right to withdraw their consent at any time for any reason whatsoever without any prejudice to them, * The investigator may prematurely exclude a subject from the study, in agreement with the sponsor, if the subject presents one or more exclusion criteria, * Diagnosis of schizophrenia during follow-up or any other diagnosis that would lead to a change in the initial EDC diagnosis, * Any condition or situation which, in the opinion of the investigator, would be incompatible with the continuation of the study or which would lead to a bias in the management of the data.

Locations (1)

CHU de Montpellier

Montpellier, France