Actively Recruiting
Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Disorder
Led by University Hospital, Montpellier · Updated on 2025-10-07
623
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Montpellier
Lead Sponsor
C
CH Béziers
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cis man, cis woman, trans man, trans woman or non-binary
- Aged 18 to 65 years old
- Meets the DSM-5 criteria for moderate to severe major depressive episode and is eligible for antidepressant treatment
You will not qualify if you...
- 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), except benzodiazepines and hydroxyzine as per approved doses
- Patients with unstable physiological state or serious medical condition as judged by the investigator
- Pregnant or breastfeeding patients
- Patients with known autoimmune disease (e.g., Crohn's disease, thyroiditis) or other conditions potentially altering immune biomarker blood levels
- Patients unable to give informed consent or receive information
- Patients not covered by social security
- Patients participating in another interventional study on inclusion day
- Patients under court protection
- Patients vaccinated less than 30 days ago
- Patients with difficulties reading, understanding, or speaking French
- Participants may withdraw consent anytime without prejudice
- Investigator may exclude subjects for new diagnosis (e.g., schizophrenia) or conditions incompatible with study continuation or data management bias
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHU de Montpellier
Montpellier, France, 34090
Actively Recruiting
Research Team
R
Raoul BELZEAUX
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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