Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: EDIT-B test for Bipolar Disorder

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.

Official registry: https://clinicaltrials.gov/study/NCT06507787 · Alcediag · enrollment listed as 450

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are EDIT-B test, or EDIT-B test (without giving result). The registry lists allocation as randomized. Depression is one of the most common mental disorders, affecting nearly 10% of men and 20% of women worldwide.

They plan to enroll about 450 people at 7 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

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

Interventions: EDIT-B test, EDIT-B test (without giving result)

Primary outcome (registry wording): Improvement in depressive symptoms between inclusion and 15-16 weeks visit.

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • 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
  • 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
  • Family history of bipolar disorder
  • Onset of the first MDE before the age of 25

Public study contact (from the registry)

Mary Menhem, PharmD, MSc

+33788970700

mary.menhem@alcediag-alcen.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

7 listed

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FAQ about this NCT record

Is NCT06507787 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06507787?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06507787?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary