Clinical trial NCT06507787: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Major Depressive Disorder
Keywords: Clinical Utility
Bipolar Disorder
Major Depressive Disorder
Lead sponsor: Alcediag
Sponsor class: INDUSTRY
Collaborators: name: BPIfrance
name: Synlab Holding Deutschland GmbH
name: GHU Paris Psychiatrie et Neurosciences
name: CH Erstein
name: AP-HP Corentin-Celton
name: Clinique Villa des Roses
name: Clinique Le clos Montaigne
name: Clinique Médicale de Ville d'Avray
name: EPSM 74
First posted: 2024-07-18
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 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 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

Primary outcomes:
measure: Improvement in depressive symptoms between inclusion and 15-16 weeks visit.
timeFrame: 4 months (from inclusion visit to 15-16 weeks visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Erstein
country: France
facility: CH Erstein
city: Issy-les-Moulineaux
country: France
facility: AP-HP Corentin Celton
city: La Roche-sur-Foron
country: France
facility: Etablissement Public de Santé Mentale (EPSM) 74
city: Lyon
country: France
facility: Clinique Villa des Roses
city: Montrond-les-Bains
country: France
facility: Clinique Le Clos Montaigne
city: Paris
country: France
facility: GHU Paris Psychiatrie et Neurosciences
city: Ville d'Avray
country: France
facility: Clinique Médicale de Ville d'Avray
Study officials:
References: