Venous blood sample for measuring blood biomarkers related to bipolar disorderStandardized psychiatric assessment tools
Venous blood sample for measuring blood biomarkers related to bipolar disorder: Participants will undergo a venous blood draw for analysis by an investigational composite medical device designed to aid in the diagnosis of bipolar disorder. The device analyzes specific circulating biomarkers hypothesized to differ between patients with bipolar disorder and those with unipolar depression.
Standardized psychiatric assessment tools: Participants will complete validated psychiatric screening tools used as reference standards to evaluate bipolar disorder, including the Mood Disorder Questionnaire (MDQ). These tools will be used to compare their diagnostic output with that of the investigational blood test.
Study 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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Sensitivity and specificity of the composite medical device, using the full clinical evaluation as a reference — Through study completion, an 8 weeks follow-up for each patient To assess the sensitivity and specificity of a composite diagnostic device using a biomarker-based algorithm (IL-6, IL-10, IL-15, IL-27, CXCL10), combined with clinical data (age, depression severity via QIDS, psychotropic treatment), to identify bipolar disorder in primary care patients with a depressive episode. The algorithm, developed by the investigators, will be implemented in the eCRF and classify patients as bipolar, non-bipolar, or in a grey zone. The reference diagnosis will be established by an expert psychiatrist using the MINI interview and a full clinical evaluation, including medical history and patient records, following standardized procedures for optimal diagnostic accuracy.
Trial sites (1)
Facility
City
Region
Status
CHU de Montpellier
Montpellier
France
Recruiting
More University Hospital, Montpellier trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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