Evaluating the EDIT-B Blood Test for Patients with Major Depression

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 testing a new blood test to see if it can help doctors better understand and treat people aged 18 to 65 who are dealing with major depression.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Alcediag (Industry-sponsored)
• Locations: 7 sites (Erstein and 6 other locations)
• Trial ID: NCT06507787 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of the EDIT-B blood test on the health status of patients experiencing a major depressive episode (MDE). It aims to determine the clinical utility and economic aspects of the test, particularly in differentiating between major depressive disorder and bipolar disorder. Patients aged 18 to 65 with moderate to severe MDE will be included, and the study will assess the effectiveness of the EDIT-B test in guiding treatment decisions. The study is designed to improve the management of depression by providing clearer diagnostic insights.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 experiencing a moderate to severe major depressive episode with potential bipolar disorder indicators.

Not a fit: Patients with a well-established diagnosis of bipolar disorder or those whose depression is linked to schizophrenia or autism spectrum disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses and tailored treatments for patients with major depressive episodes.

How similar studies have performed: Other studies have shown promise in using blood tests for diagnosing mental health conditions, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Patients with a MDE, moderate to severe (DSM V criteria and MADRS score ≥19)
* Age between 18 and 65 years, gender indifferent
* Benefitting from health insurance coverage
* Having signed an informed consent and agreed to follow the study protocol to completion
* Patients for whom there is doubt regarding a bipolar disorder diagnosis, and/or presenting one or more of the following criteria:

  * More than 3 episodes of MDE in personal medical history
  * Psychotic symptoms
  * Family history of bipolar disorder
  * Onset of the first MDE before the age of 25
  * Atypical symptoms or mixed features during depressive episodes
  * Addiction
  * Personal history of suicide attempts
  * Resistance to antidepressants
  * Postpartum depression within 6 months of birth

Exclusion Criteria:

* Depression in the context of schizophrenia or autism spectrum disorder
* Patient with a well-established diagnosis of bipolar disorder
* Patients who is already receiving a mood stabilizer
* Severe somatic diseases that may interfere with the follow-up or associated with treatments at risk of secondary manic decompensation
* Neurodegenerative diseases
* Pregnant women

Where this trial is running

Erstein and 6 other locations

• CH Erstein — Erstein, France (Not_yet_recruiting)
• AP-HP Corentin Celton — Issy-les-Moulineaux, France (Not_yet_recruiting)
• Etablissement Public de Santé Mentale (EPSM) 74 — La Roche-sur-Foron, France (Not_yet_recruiting)
• Clinique Villa des Roses — Lyon, France (Recruiting)
• Clinique Le Clos Montaigne — Montrond-les-Bains, France (Recruiting)
• GHU Paris Psychiatrie et Neurosciences — Paris, France (Recruiting)
• Clinique Médicale de Ville d'Avray — Ville-d'Avray, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Diana Vetter

Conditions Bipolar Disorder; Major Depressive Disorder; Clinical Utility