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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CH Erstein
NOT_YET_RECRUITING
Erstein
AP-HP Corentin Celton
NOT_YET_RECRUITING
Issy-les-moulineaux
Etablissement Public de Santé Mentale (EPSM) 74
NOT_YET_RECRUITING
La Roche-sur-foron
Clinique Villa des Roses
RECRUITING
Lyon
Clinique Le Clos Montaigne
RECRUITING
Montrond-les-bains
GHU Paris Psychiatrie et Neurosciences
RECRUITING
Paris
Clinique Médicale de Ville d'Avray
NOT_YET_RECRUITING
Ville-d'avray
Contact Information
Primary
Diana Vetter
diana.vetter@alcediag-alcen.com
+33788970700
Backup
Benjamin Dubuc
benjamin.dubuc@alcediag-alcen.com
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2027-05
Participants
Target number of participants: 450
Treatments
Experimental: With EDIT-B test result
The investigator will have the EDIT-B® test result to guide the treatment strategy.
Placebo_comparator: Without EDIT-B test result
The investigator will not have the EDIT-B® test result, but EDIT-B® is still performed on participants in the beginning of the study.
Related Therapeutic Areas
Sponsors
Collaborators: GHU Paris Psychiatrie et Neurosciences, EPSM 74, Clinique Médicale de Ville d'Avray, Clinique Villa des Roses, Clinique Le clos Montaigne, BPIfrance, AP-HP Corentin-Celton, CH Erstein, Synlab Holding Deutschland GmbH
Leads: Alcediag

This content was sourced from clinicaltrials.gov