Blood biomarker plus questionnaire test to help diagnose bipolar disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU de Montpellier
  Montpellier, France Recruiting

Study contacts

• Study coordinator: Raoul BELZEAUX
• Email: raoul.belzeaux@chu-montpellier.fr
• Phone: +33 0467337913

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.