Status:
RECRUITING
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
Lead Sponsor:
Alcediag
Collaborating Sponsors:
BPIfrance
Synlab Holding Deutschland GmbH
Conditions:
Bipolar Disorder
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 behavio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06507787
Start Date
February 3 2025
End Date
May 1 2027
Last Update
February 18 2025
Active Locations (7)
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1
CH Erstein
Erstein, France
2
AP-HP Corentin Celton
Issy-les-Moulineaux, France
3
Etablissement Public de Santé Mentale (EPSM) 74
La Roche-sur-Foron, France
4
Clinique Villa des Roses
Lyon, France