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New treatment option for Bipolar Disorder (BD)
Official title Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Disorder
ClinicalTrials.gov ID: NCT07031817
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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-
- Patients under guardianship or trusteeship,
- Patients with schizophrenia according to DSM-5 criteria,
You likely can't join if
- 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...
- 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...
See the full eligibility 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-
- 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...
- 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 treatment 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.