SEM EDIT-BNCT06507787

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

StatusRecruiting

PhaseNot applicable

SponsorAlcediag

Primary completionApr 2028 (estimated)

At risk: Primary completion moved at least 1 year 10 months later.

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 2, 2026 Primary completion pushed from May 2026 to Apr 2028 Show 4 more changesShow less
- Study completion pushed from May 2027 to Jun 2028
- Eligibility criteria expanded, about 20 words
- Site details revised at 1 of 7 sites
- Collaborators: details revised at 1 of 9 entries
Notable Feb 14, 2025 Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
- Start date changed from estimate of Sep 2024 to Feb 3, 2025
- Primary endpoint revised
- Study sites: 0 to 7
- Primary completion date: Aug 2026 to May 2026
- Study completion date: Aug 2026 to May 2027
- Collaborators: 2 to 9
Jul 17, 2024 Study First Submitted

Notable: the plan changed

Endpoints

Primary

Improvement in depressive symptoms between inclusion and 15-16 weeks visit.

Timeframe: 4 months (from inclusion visit to 15-16 weeks visit)

Arms and interventions

With EDIT-B test resultExperimental

The investigator will have the EDIT-B® test result to guide the treatment strategy.

Without EDIT-B test resultPlacebo comparator

The investigator will not have the EDIT-B® test result, but EDIT-B® is still performed on participants in the beginning of the study.

Diagnostic tests: EDIT-B test, EDIT-B test (without giving result)

Sites

7 sites in 1 country

About this trial

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.

Trial details

Enrollment: 450 participants (estimated)
Started: Feb 3, 2025
Study completion: Jun 2028 (estimated)
Eligibility: 18 to 65, all sexes, no healthy volunteers
Design: Interventional, randomized, open label, diagnostic
Conditions: Bipolar Disorder, Major Depressive Disorder
Collaborators: BPIfrance, Synlab Holding Deutschland GmbH, GHU Paris Psychiatrie et Neurosciences, CH Erstein, AP-HP Corentin-Celton, Clinique Villa des Roses, Clinique Le clos Montaigne, Clinique Médicale de Ville d'Avray, EPSM 74
First posted: Jul 18, 2024
Registry updated: Nov 3, 2026
Last verified: Nov 2026

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