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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EDIT-B test, EDIT-B test (without giving result).
- Who it may be relevant to
- Registry conditions: Bipolar Disorder, Major Depressive Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Depression is one of the most common mental disorders, affecting nearly 10% of men and 20% of women worldwide. It is associated with a significant increase in mortality, mainly due to suicidal behavior. The Diagnostic and Statistical Manual of Mental Disorders (DSM) defines a Major Depressive Episode (MDE) by a combination of at least five different symptoms, with at least one depressed mood or loss of interest. MDEs can occur in isolation or as part of Major Depressive Disorder (MDD) or bipolar disorder (BD). Bipolar disorders affect 2% of the world's population and are defined by episodes of mania (Type I BD) or hypomania (Type II BD) alternating with episodes of depression and periods of remission. Depression occurring whether in the context of BD or MDD is defined with the same clinical criteria. However, the pharmacological treatments are different in the two groups. In particular, antidepressants prescribed without a thymoregulator in bipolar patients can lead to a worsening of the episode, favoring suicidal behavior or a manic turn. The average interval between the onset of BD symptoms and appropriate diagnosis is estimated to be approximately 7 years, which delays appropriate management and treatment and increases the risk of suicide. Biological markers able to differentiate between the different types of depression were lacking before the advent of EDIT-B®; one of the main objectives of this research is to measure the clinical impact of the use of EDIT-B® in the short and medium term on the management of patients with BD and major depression. The health economic aspect will also be considered. In total, 450 patients in two different groups (EDIT-B® group and control group) will be recruited over a study timeline of 24 months. Study participation is over 6 months with 4 visits.
Interventions
- Diagnostic test EDIT-B test
EDIT-B® is the first blood test for the differential diagnosis of bipolar disorder (BD) and major depression. It consists of a biological analysis (including targeted RNA sequencing) followed by a software interpretation thanks to an algorithm developed with AI. The test is CE marked, clinically validated on two independent cohorts and shows an excellent performance with a sensitivity and specificity of more than 80%. For performing the test, a blood sample of 2.5 ml will be drawn using PAXgene - Diagnostic test EDIT-B test (without giving result)
EDIT-B® is the first blood test for the differential diagnosis of bipolar disorder (BD) and major depression. It consists of a biological analysis (including targeted RNA sequencing) followed by a software interpretation thanks to an algorithm developed with AI. The test is CE marked, clinically validated on two independent cohorts and shows an excellent performance with a sensitivity and specificity of more than 80%. For performing the test, a blood sample of 2.5 ml will be drawn using PAXgene
Primary outcome measures
- Improvement in depressive symptoms between inclusion and 15-16 weeks visit. [Time frame: 4 months (from inclusion visit to 15-16 weeks visit)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 7 centers
- CH Erstein — Erstein
- AP-HP Corentin Celton — Issy-les-Moulineaux
- Etablissement Public de Santé Mentale (EPSM) 74 — La Roche-sur-Foron
- Clinique Villa des Roses — Lyon
- Clinique Le Clos Montaigne — Montrond-les-Bains
- GHU Paris Psychiatrie et Neurosciences — Paris
- Clinique Médicale de Ville d'Avray — Ville-d'Avray
Identifiers
NCT: NCT06507787 · SEM EDIT-B