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

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medical test that combines a simple blood test with a mood questionnaire to help doctors tell the difference between bipolar disorder and regular depression in adults who are currently experiencing a major depressive episode. The goal is to see if this combined test can accurately identify bipolar disorder compared to the usual psychiatric evaluations that doctors use. This could make it easier and quicker to diagnose bipolar disorder, which often gets missed because its symptoms can look like regular depression.

Adults aged 18 to 65 who are experiencing moderate to severe depression and are about to start antidepressant treatment may be eligible to participate. If you join the study, you will provide a blood sample for the new test, complete some mood questionnaires, and share some basic personal and medical information. The study is not yet recruiting, and certain people, such as those with schizophrenia, pregnant or breastfeeding individuals, or those with certain medical conditions, won’t be eligible. Participants can leave the study at any time. This research aims to improve how bipolar disorder is diagnosed in primary care, potentially leading to better and more personalized treatment.

Gender

ALL

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.