RecruitingNAINTERVENTIONAL

Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Disorder

This study aims to make diagnosing bipolar disorder easier and more accurate for adults experiencing a major depressive episode. Researchers are testing a new method that combines a simple blood test with a well-known questionnaire. The goal is to see if this new approach can reliably tell bipolar disorder apart from other forms of depression, especially in settings like your GP surgery. Currently, it can be tricky to get a correct diagnosis because the symptoms often look similar to other types of depression. By comparing the new method's results with opinions from mental health specialists, the study hopes to find a quicker and better way to help people get the right diagnosis and treatment sooner.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Montpellier

Enrolment target

623

Start

30 Sep 2025

Estimated completion

01 Jul 2028

Bipolar Disorder (BD)Major Depressive Episode (MDE)Primary Care Major Depression

What is this study about?

Imagine you're feeling very down, and you visit your doctor. It can sometimes be hard for doctors to tell if these low feelings are part of bipolar disorder or another type of depression, as the symptoms can be very similar. This study is looking for a better way to make that diagnosis.

Researchers are testing a new tool that combines two things: a blood test that looks for specific markers in your blood, and a questionnaire you fill out about your mood. The main idea is to see if this combination can more accurately identify bipolar disorder in adults who are currently feeling very depressed, especially when they first visit their local GP surgery. This could potentially lead to faster and more accurate diagnoses, meaning people get the right support sooner.

Why is this so important? Bipolar disorder affects many people, and getting the wrong diagnosis can mean getting treatment that isn't quite right, which might not help as much as it should. This study aims to find out if this new test can reliably tell the difference between bipolar disorder and what's called 'unipolar depression'. They will compare how well this new test works against the methods mental health experts usually use. If successful, this new tool could make a big difference in how bipolar disorder is identified.

Key takeaways

This study is testing a new blood test and questionnaire to improve bipolar disorder diagnosis.
It aims to help doctors tell the difference between bipolar disorder and other types of depression.
Participants will give a blood sample and complete mood questionnaires.
The goal is quicker and more accurate diagnoses for future patients.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old. You should currently be experiencing a moderate to severe episode of depression, which means you're feeling very low and might be eligible for antidepressant treatment.

There are also some reasons why you couldn't join. For example, if you're under legal guardianship, have been diagnosed with schizophrenia, or have recently taken certain medications (apart from some anxiety medications). You also can't take part if you have a serious ongoing health condition, are pregnant or breastfeeding, have certain autoimmune diseases (like Crohn's disease or thyroid problems), or if you can't give your informed agreement to be in the study.

Other reasons you might not be able to join include being involved in another study at the same time, having received a vaccine in the last 30 days, or if you have difficulty reading, understanding, or speaking French. The research team will review all this information to see if the study is a good fit for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Are you currently experiencing a moderate to severe depressive episode?
Do you not have a diagnosis of schizophrenia?
Are you not pregnant or breastfeeding?
Have you not received a vaccine in the last 30 days?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, here's what you can expect:

* **Blood Sample:** You will be asked to provide a blood sample. This sample will be specially analysed using the new diagnostic device the researchers are testing. * **Questionnaires:** You'll complete a few questionnaires about your mood and feelings. These are standard tools used to understand symptoms, like the Mood Disorder Questionnaire (MDQ). * **Information Sharing:** You'll be asked to share some general information about yourself, such as your age, background, and medical history, that helps the researchers understand your health picture.

There isn't any medication involved specifically for the study. The study focuses on diagnosis, not treatment. The exact number of visits isn't specified, but it primarily involves an initial assessment collection. You'll have the right to leave the study at any time.

Potential risks and benefits

Taking part in this study has potential benefits, though not directly for your current treatment. You would be contributing to scientific knowledge that could lead to earlier and more accurate diagnoses of bipolar disorder for others in the future. The risks involved are generally low, mainly related to the blood draw (like slight bruising or discomfort) and the time spent completing questionnaires. There's no new medication involved in the study itself. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CHU de Montpellier
Verified postcode
Montpellier, France· Recruiting

Common questions

What is bipolar disorder?

Bipolar disorder is a mental health condition where people experience significant mood changes, including periods of feeling very high or irritable (mania or hypomania) and periods of feeling very low (depression).

Why is it hard to diagnose bipolar disorder?

It can be tricky because the depressive periods often look very similar to other types of depression, and people might not report their 'high' moods to their doctor.

What is this 'new device' exactly?

It's a combination of a blood test that looks for specific 'markers' in your blood and a standard questionnaire about your mood, designed to help distinguish bipolar disorder from other depression.

Will this study change my current treatment?

No, this study is about diagnosis, not treatment. Any treatment decisions will still be made by you and your doctor, based on your individual needs.

How long will I be in the study?

The study focuses on an initial assessment to collect blood and questionnaire data. The total duration isn't specified, but it's not a long-term treatment trial.

How to find out more

Raoul BELZEAUX

raoul.belzeaux@chu-montpellier.fr +33 0467337913 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.