NCT07031817 Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Disorder
| NCT ID | NCT07031817 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Bipolar Disorder (BD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 623 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 623 participants in total. It began in 2025-09-30 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07031817 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Bipolar Disorder (BD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07031817 currently recruiting?
Yes, NCT07031817 is actively recruiting participants. Contact the research team at raoul.belzeaux@chu-montpellier.fr for enrollment information.
Where is the NCT07031817 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT07031817 clinical trial?
NCT07031817 is sponsored by University Hospital, Montpellier. The trial plans to enroll 623 participants.
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