NCT05603819Completed
Clinical Validation Study for EDIT-B Test: an Aid for Differential Diagnosis of Bipolar Disorder, Based on RNA Editing Blood Biomarkers
Source: ClinicalTrials.gov · Last updated 17 Dec 2024
Brief summary (registry, in English)
Differentiation between major depressive disorder (MDD) and bipolar disorder (BD) as soon as possible in the patient journey represents a major clinical issue. When the patient is in a depressive phase, the symptoms are similar between the two pathologies and the current clinical scales fail in distinguishing them. Physicians often report this difficulty and as a consequence, the mean time from onset to bipolar disorder diagnosis is currently 7.5 years. These diagnostic delays and misdiagnosis lead to damaging consequences for patients and their loved ones: worsening of symptoms, comorbidities, suicide risk and inadequate care resulting in severe impairment in social and occupational functioning. Faced with these high expectations for accurate diagnostic methods for an earlier management of psychiatric patients, the combination of relevant clinical features and biomarkers could stand for a solution, leading to a personalised approach in patients with mood disorders. In a first clinical discovery study, a panel of RNA biomarkers in the blood of patients with a major depressive episode (MDE) has been identified, allowing to differentiate bipolar disorder from MDD (unipolar depression). These biomarkers are based on RNA modifications, namely RNA editing, that could be identified using molecular biology, NGS and artificial intelligence. This panel constitutes EDIT-B test, which is based on Alcediag's proprietary and patented biomarkers and algorithms. The present study aims to validate the biomarker signatures proposed by Alcediag by measuring the association between the modifications of the RNA editing and major depressive disorder/ bipolar disorder diagnosis, in patients with a MDE in real-life setting pilot centres.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 418 (actual)
- First submitted
- 28 Oct 2022
- Start date
- 29 Jun 2022
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Alcediag
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT05603819
What you commit to
- Study type: Observational
- Participants enrolled: 418
- From 29 Jun 2022 to the primary completion date, 30 Sept 2024
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- MDD patients with first degree family history of bipolar disorder
- Unipolar or bipolar depression secondary to major central nervous system affections, including infections in the brain, tumours of the brain, stroke, Alzheimer's disease, Parkinson's disease, Multiple sclerosis, other major brain affections
- Schizo-affective patients
- Abbrevations:
- BD Bipolar Disorder DSM-5 Diagnostic and Statistical Manual of Mental disorders 5 MADRS Montgomery-Asberg Depression Rating Scale MDD Major Depressive Disorder MDE Major Depressive Episode MINI Mini-International Neuropsychiatric Interview YMRS Young Mania Rating Scale
Other
- YMRS \> 12
- Pregnant women
Who the study is looking for
- Signed informed consent.
- Male or female ≥ 18 and ≤ 80 years of age at inclusion.
- MADRS ≥ 20
- In- and out-patients can be recruited.
- Diagnosed with MDE with the MINI for DSM-5
- Currently treated for the MDE
- Diagnosed with MDD or BD with the MINI for DSM-5.
- For patients with BD: at least one manic or hypomanic episode
- For patients with MDD: at least one MDE
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Capital Region of Denmark Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Parc Sanitari Sant Joan de Déu Coordinator of this site? Confirm its status | Sant Boi de Llobregat | Spain | Unknown status |
| GHU Paris Psychiatrie & Neurosciences Coordinator of this site? Confirm its status | Paris | France | Unknown status |
Related publications
- EDIT-B consortium: an external pan-European validation of an innovative machine learning-based test for bipolar disorder diagnosis.BMJ Ment Health · 2026 · PMID 42833865
This page is information, not medical advice. Discuss any trial with your doctor.