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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinique Villa des Roses
  Lyon, France Recruiting
• Clinique Le Clos Montaigne
  Montrond-les-Bains, France Recruiting
• GHU Paris Psychiatrie et Neurosciences
  Paris, France Recruiting
• 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

Study contacts

• Study coordinator: Mary Menhem, PharmD, MSc
• Email: mary.menhem@alcediag-alcen.com
• Phone: +33788970700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.