Blood biomarker plus questionnaire test to help diagnose 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
This trial will test whether a blood-based biomarker algorithm combined with the Mood Disorder Questionnaire (MDQ) can accurately identify adults with bipolar disorder who are currently experiencing a major depressive episode in primary care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 623 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT07031817 on ClinicalTrials.gov |
What this trial studies
Adults aged 18–65 presenting in primary care with a moderate to severe major depressive episode will provide a venous blood sample and complete standardized psychiatric questionnaires (including the MDQ and MINI). The investigational composite device uses a blood biomarker panel together with the MDQ score to generate a diagnostic output. Results from the device will be compared to a standardized psychiatric clinical evaluation to measure sensitivity, specificity, and overall clinical utility. Key exclusions include recent psychotropic medication use, known autoimmune disease, pregnancy or breastfeeding, schizophrenia, and unstable medical conditions.
Who should consider this trial
Good fit: Adults 18 to 65 of any gender who meet DSM-5 criteria for a current moderate to severe major depressive episode and are eligible for antidepressant treatment are the intended participants.
Not a fit: People who are pregnant or breastfeeding, have a known autoimmune disease, have schizophrenia, have recently taken psychotropic medications within the specified washout windows, or have unstable medical conditions are excluded and unlikely to benefit from this test.
Why it matters
Potential benefit: If successful, the test could help clinicians more quickly and accurately distinguish bipolar disorder from unipolar depression, reducing misdiagnosis and guiding appropriate treatment earlier.
How similar studies have performed: Early research combining blood biomarkers with clinical questionnaires has shown promising signals for distinguishing bipolar from unipolar depression, but these approaches remain novel and require larger clinical validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Montpellier
- CHU de Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Raoul BELZEAUX
- Email: raoul.belzeaux@chu-montpellier.fr
- Phone: +33 0467337913
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.