Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Disorder
Recruiting
N/A
Interventional Study
Bipolar Disorder (BD)
Major Depressive Episode (MDE)
Primary Care
Major Depression
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 623 (estimated)
- Sponsor
- University Hospital, Montpellier · Other
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About This Trial
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 diagnost…
Trial Locations
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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,
*…
Contacts