All studies
RecruitingNAINTERVENTIONAL

Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects

This study is investigating a new blood test called EDIT-B®. It's designed to help doctors figure out if someone experiencing a depressive episode has major depressive disorder or bipolar disorder. This is really important because while both conditions involve feeling depressed, they need different treatments. For people with bipolar disorder, using the wrong medication can sometimes make things worse. Currently, it can take many years to correctly diagnose bipolar disorder, which means people might not get the right help they need and could be at higher risk of harm. This study aims to see if the EDIT-B® test can speed up this diagnosis, improve patient care, and understand the economic benefits. We will involve 450 people over two years, with each person taking part for about six months.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Alcediag
Enrolment target
450
Start
03 Feb 2025
Estimated completion
01 May 2027

What is this study about?

Feeling low and depressed is a very common experience, affecting many people in the UK. Sometimes these feelings are part of Major Depressive Disorder, and sometimes they are part of Bipolar Disorder. Both conditions involve periods of depression, but Bipolar Disorder also includes periods of feeling extremely high or energetic. Diagnosing these two conditions correctly is really important because the treatments are quite different. Using antidepressants alone for someone with bipolar disorder can sometimes make their condition worse or even lead to harmful thoughts.

Unfortunately, it often takes a long time, sometimes many years, for someone with bipolar disorder to get the correct diagnosis. This delay can mean they don't get the most effective treatment for their condition and can face more difficulties, including a higher risk of self-harm. Doctors look for specific signs and symptoms to make a diagnosis, but it can still be tricky to tell the difference, especially when someone is only experiencing depression at the time.

This study is looking into a new blood test called EDIT-B®. The aim is to see if this test can help doctors quickly and accurately distinguish between Major Depressive Disorder and Bipolar Disorder when someone is going through a depressive episode. By getting a quicker and more accurate diagnosis, patients could receive the right treatment sooner, which could significantly improve their health and well-being. The study will also look at how this test might benefit the healthcare system as a whole.

Key takeaways

  • The study tests a new blood test (EDIT-B®) for depression.
  • It aims to help doctors tell major depression from bipolar disorder.
  • This is crucial for getting the right treatment and preventing harm.
  • Each participant will be involved for about six months.
  • The study also looks at the overall benefits to healthcare.

Who may be eligible?

To join this study, you need to be experiencing a moderate to severe depressive episode. You should be between 18 and 65 years old and have health insurance. Crucially, the doctors involved must be unsure whether your depression is part of major depressive disorder or bipolar disorder.

They will be especially interested if you have had three or more depressive episodes before, have experienced unusual thoughts during depression, have a family member with bipolar disorder, had your first depressive episode before age 25, or if other treatments haven't worked well for you.

You cannot join if you already have a definite diagnosis of bipolar disorder, are taking certain medications for mood, have a severe physical illness that could affect the study, have certain brain conditions, or are pregnant. We are also not looking for people whose depression is clearly linked to schizophrenia or autism.

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.

  1. Are you experiencing a moderate to severe depressive episode right now?
  2. Are you between 18 and 65 years old?
  3. Are your doctors unsure if your depression is major depressive disorder or bipolar disorder?
  4. Have you *not* had a confirmed diagnosis of bipolar disorder already?
  5. Are you *not* pregnant or taking certain mood-stabilising medications?
Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will last for about six months. During this time, you will have four visits to the study clinic. These visits will allow the study team to check on your progress and carry out any necessary assessments. You won't be given any new medications as part of the study itself, but your doctors will continue to manage your usual depression treatment. The main thing we're looking at is how the EDIT-B® blood test might influence your diagnosis and care.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the EDIT-B® test might help your doctor get a clearer understanding of your condition sooner, leading to more appropriate treatment. As this is still a research study, we don't know for certain what the benefits will be for every individual. The main risk involves having a blood test, which can cause a little discomfort or bruising. You can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (7)

  • CH Erstein
    Verified postcode
    Erstein, France· Not yet recruiting
  • AP-HP Corentin Celton
    Verified postcode
    Issy-les-Moulineaux, France· Not yet recruiting
  • Etablissement Public de Santé Mentale (EPSM) 74
    Verified postcode
    La Roche-sur-Foron, France· Not yet recruiting
  • Clinique Villa des Roses
    Verified postcode
    Lyon, France· Recruiting
  • Clinique Le Clos Montaigne
    Verified postcode
    Montrond-les-Bains, France· Recruiting
  • GHU Paris Psychiatrie et Neurosciences
    Verified postcode
    Paris, France· Recruiting
  • Clinique Médicale de Ville d'Avray
    Verified postcode
    Ville-d'Avray, France· Not yet recruiting

Common questions

What is the main goal of this study?

The goal is to see if a new blood test, EDIT-B®, can help doctors quickly tell the difference between major depression and bipolar disorder.

Why is it important to tell the difference between these types of depression?

They need different treatments. Getting the wrong treatment for bipolar disorder can sometimes make things worse.

What will I have to do if I join?

You'll have a blood test and attend about four study visits over six months. Your doctors will continue to manage your usual care.

Will I get the results of the EDIT-B® test?

One group in the study will have the test result shared with their doctor, and another group will not, to see the difference it makes.

What if I change my mind after joining?

You are free to leave the study at any time, and it won't affect your medical care.

How to find out more

Diana Vetter

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

Interested in taking part?

Register your interest

Share your details and the research team for "Evaluation of the Impact of the EDIT-B® Blood Test on the He…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.