Blood test may end misdiagnosis of bipolar disorder
NCT ID NCT07031817
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new tool that combines a blood test with a questionnaire to help primary care doctors correctly identify bipolar disorder in people who are currently experiencing depression. The goal is to see if this tool can accurately tell the difference between bipolar disorder and regular depression. About 623 adults with moderate to severe depression will provide a blood sample and answer questions, and their results will be compared to a full psychiatric evaluation.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 623 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Montpellier
RECRUITINGMontpellier, 34090, France
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