Bipolar DisorderEDIT-BNCT05603819
Clinical Validation Study for EDIT-B Test: an Aid for Differential Diagnosis of Bipolar Disorder, Based on RNA Editing Blood Biomarkers
An observational study of Bipolar Disorder and Major Depressive Disorder, run by Alcediag at 4 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bipolar Disorder, Major Depressive Disorder
- What is being tested?
- EDIT-B
- Type of treatment
- Medical device
- How many people
- 418 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 29 Jun 2022to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with depression meeting the MDE criteria in DSM-5 using the MINI will be eligible for the study. They can be in- and out-patients for each clinical center.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- MDD patients with first degree family history of bipolar disorder
- YMRS > 12
- Pregnant women
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Spain2 sites
Hospital Clínic de Barcelona
Barcelona, 08036
Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, 08830
About this study
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.
- Conditions
- Bipolar Disorder, Major Depressive Disorder
- Being tested
- EDIT-B
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDIT-BDevice
To perform EDIT-B test, questionnaires and 2x0.5 mL whole blood are collected from each patient.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar disorder | Patients with depression suffering from bipolar disorder. Receives: Device: EDIT-B | |
| Major depressive disorder | Patients with depression suffering from major depressive disorder. Receives: Device: EDIT-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performances of EDIT-B signatures on MDD vs. BD differentiation in patients with depression.
The objective of this study is to estimate three EDIT-B signatures in term of their external validity. For this purpose, performances of the tests will be estimated by calculating for each signature its Sensitivity (i.e. the probability that a test will indicate 'bipolar disorders' among those with this disease), Specificity (i.e. the fraction of those without bipolar disorders who will have a negative test result) and its Accuracy to predict the diagnosis of bipolar disorders. In addition, Area under the ROC curves of each EDIT-B signature will be calculated.
The categorisation of the type of disorder (MDD vs. BD) by experts will be based on the MINI considered as the gold standard for diagnosis.
The performances of the tested signatures will be compared on a two-by-two basis by comparing sensitivities and specificity , using the methods based on Mac Nemar test proposed by Hawass. AUC-ROC of the 3 signatures will also be compared by DeLong method.
Measured: Specimen collection needed for evaluation of diagnostic performances: 1 day (= 1 visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start29 Jun 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcediag
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Clinic of Barcelona, Fundacion Clinic per a la Recerca Biomédica, Region Capital Denmark, GHU Paris Psychiatry & Neurosciences, Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, Synlab Italie
- Responsible party
- Sponsor
- Investigators
- Eduard Vieta, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603819
- Sponsor's protocol ID
- EDIT-B
- Acronym
- EDIT-B
- Status last verified
- Dec 2024
- First submitted
- 28 Oct 2022
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salvetat N, Checa-Robles FJ, Patel V, Cayzac C, Dubuc B, Chimienti F, Abraham JD, Dupre P, Vetter D, Mereuze S, Lang JP, Kupfer DJ, Courtet P, Weissmann D. A game changer for bipolar disorder diagnosis using RNA editing-based biomarkers. Transl Psychiatry. 2022 May 4;12(1):182. doi: 10.1038/s41398-022-01938-6.
PubMed 35504874Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.
PubMed 444788Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
PubMed 9881538Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978 Nov;133:429-35. doi: 10.1192/bjp.133.5.429.
PubMed 728692Kim SH, Kim HJ, Lee SI, Jo MW. Comparing the psychometric properties of the EQ-5D-3L and EQ-5D-5L in cancer patients in Korea. Qual Life Res. 2012 Aug;21(6):1065-73. doi: 10.1007/s11136-011-0018-1. Epub 2011 Sep 23.
PubMed 21947656Hawass NE. Comparing the sensitivities and specificities of two diagnostic procedures performed on the same group of patients. Br J Radiol. 1997 Apr;70(832):360-6. doi: 10.1259/bjr.70.832.9166071.
PubMed 9166071DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.
PubMed 3203132Buderer NM. Statistical methodology: I. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity. Acad Emerg Med. 1996 Sep;3(9):895-900. doi: 10.1111/j.1553-2712.1996.tb03538.x.
PubMed 8870764Merikangas KR, Jin R, He JP, Kessler RC, Lee S, Sampson NA, Viana MC, Andrade LH, Hu C, Karam EG, Ladea M, Medina-Mora ME, Ono Y, Posada-Villa J, Sagar R, Wells JE, Zarkov Z. Prevalence and correlates of bipolar spectrum disorder in the world mental health survey initiative. Arch Gen Psychiatry. 2011 Mar;68(3):241-51. doi: 10.1001/archgenpsychiatry.2011.12.
PubMed 21383262Carvalho AF, Solmi M, Sanches M, Machado MO, Stubbs B, Ajnakina O, Sherman C, Sun YR, Liu CS, Brunoni AR, Pigato G, Fernandes BS, Bortolato B, Husain MI, Dragioti E, Firth J, Cosco TD, Maes M, Berk M, Lanctot KL, Vieta E, Pizzagalli DA, Smith L, Fusar-Poli P, Kurdyak PA, Fornaro M, Rehm J, Herrmann N. Evidence-based umbrella review of 162 peripheral biomarkers for major mental disorders. Transl Psychiatry. 2020 May 18;10(1):152. doi: 10.1038/s41398-020-0835-5.
PubMed 32424116Carvalho AF, Firth J, Vieta E. Bipolar Disorder. N Engl J Med. 2020 Jul 2;383(1):58-66. doi: 10.1056/NEJMra1906193. No abstract available.
PubMed 32609982Fiedorowicz JG, He J, Merikangas KR. The association between mood and anxiety disorders with vascular diseases and risk factors in a nationally representative sample. J Psychosom Res. 2011 Feb;70(2):145-54. doi: 10.1016/j.jpsychores.2010.07.010. Epub 2010 Sep 18.
PubMed 21262417Pan JX, Xia JJ, Deng FL, Liang WW, Wu J, Yin BM, Dong MX, Chen JJ, Ye F, Wang HY, Zheng P, Xie P. Diagnosis of major depressive disorder based on changes in multiple plasma neurotransmitters: a targeted metabolomics study. Transl Psychiatry. 2018 Jul 10;8(1):130. doi: 10.1038/s41398-018-0183-x.
PubMed 29991685Kessing LV. Course and cognitive outcome in major affective disorder. Dan Med J. 2015 Nov;62(11):B5160.
PubMed 26522485Giridharan VV, Sayana P, Pinjari OF, Ahmad N, da Rosa MI, Quevedo J, Barichello T. Postmortem evidence of brain inflammatory markers in bipolar disorder: a systematic review. Mol Psychiatry. 2020 Jan;25(1):94-113. doi: 10.1038/s41380-019-0448-7. Epub 2019 Jun 27.
PubMed 31249382
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation Study for EDIT-B Test: an Aid for Differential Diagnosis of Bipolar Disorder, Based on RNA Editing Blood Biomarkers
- ClinicalTrials.gov ID
- NCT05603819
- Acronym / sponsor ID
- EDIT-B / EDIT-B
- Conditions
- Bipolar Disorder, Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- AlcediagIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Clinic of Barcelona, Fundacion Clinic per a la Recerca Biomédica, Region Capital Denmark, GHU Paris Psychiatry & Neurosciences, Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, Synlab Italie
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar disorder | – | Device: EDIT-BPatients with depression suffering from bipolar disorder. |
| Major depressive disorder | – | Device: EDIT-BPatients with depression suffering from major depressive disorder. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with depression meeting the MDE criteria in DSM-5 using the MINI will be eligible for the study. They can be in- and out-patients for each clinical center.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- MDD patients with first degree family history of bipolar disorder
- YMRS > 12
- Pregnant women
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDIT-BTo perform EDIT-B test, questionnaires and 2x0.5 mL whole blood are collected from each patient. | Device | Bipolar disorder, Major depressive disorder |
Primary outcome
Diagnostic performances of EDIT-B signatures on MDD vs. BD differentiation in patients with depression.
Time frame: Specimen collection needed for evaluation of diagnostic performances: 1 day (= 1 visit).
The objective of this study is to estimate three EDIT-B signatures in term of their external validity. For this purpose, performances of the tests will be estimated by calculating for each signature its Sensitivity (i.e. the probability that a test will indicate 'bipolar disorders' among those with this disease), Specificity (i.e. the fraction of those without bipolar disorders who will have a negative test result) and its Accuracy to predict the diagnosis of bipolar disorders. In addition, Area under the ROC curves of each EDIT-B signature will be calculated. The categorisation of the type of disorder (MDD vs. BD) by experts will be based on the MINI considered as the gold standard for diagnosis. The performances of the tested signatures will be compared on a two-by-two basis by comparing sensitivities and specificity , using the methods based on Mac Nemar test proposed by Hawass. AUC-ROC of the 3 signatures will also be compared by DeLong method.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Background: PubMed 35504874Salvetat N, Checa-Robles FJ, Patel V, Cayzac C, Dubuc B, Chimienti F, Abraham JD, Dupre P, Vetter D, Mereuze S, Lang JP, Kupfer DJ, Courtet P, Weissmann D. A game changer for bipolar disorder diagnosis using RNA editing-based biomarkers. Transl Psychiatry. 2022 May 4;12(1):182. doi: 10.1038/s41398-022-01938-6.
- Background: PubMed 444788Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.
- Background: PubMed 9881538Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
- Background: PubMed 728692Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978 Nov;133:429-35. doi: 10.1192/bjp.133.5.429.
- Background: PubMed 21947656Kim SH, Kim HJ, Lee SI, Jo MW. Comparing the psychometric properties of the EQ-5D-3L and EQ-5D-5L in cancer patients in Korea. Qual Life Res. 2012 Aug;21(6):1065-73. doi: 10.1007/s11136-011-0018-1. Epub 2011 Sep 23.
- Background: PubMed 9166071Hawass NE. Comparing the sensitivities and specificities of two diagnostic procedures performed on the same group of patients. Br J Radiol. 1997 Apr;70(832):360-6. doi: 10.1259/bjr.70.832.9166071.
- Background: PubMed 3203132DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.
- Background: PubMed 8870764Buderer NM. Statistical methodology: I. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity. Acad Emerg Med. 1996 Sep;3(9):895-900. doi: 10.1111/j.1553-2712.1996.tb03538.x.
- Background: PubMed 21383262Merikangas KR, Jin R, He JP, Kessler RC, Lee S, Sampson NA, Viana MC, Andrade LH, Hu C, Karam EG, Ladea M, Medina-Mora ME, Ono Y, Posada-Villa J, Sagar R, Wells JE, Zarkov Z. Prevalence and correlates of bipolar spectrum disorder in the world mental health survey initiative. Arch Gen Psychiatry. 2011 Mar;68(3):241-51. doi: 10.1001/archgenpsychiatry.2011.12.
- Background: PubMed 32424116Carvalho AF, Solmi M, Sanches M, Machado MO, Stubbs B, Ajnakina O, Sherman C, Sun YR, Liu CS, Brunoni AR, Pigato G, Fernandes BS, Bortolato B, Husain MI, Dragioti E, Firth J, Cosco TD, Maes M, Berk M, Lanctot KL, Vieta E, Pizzagalli DA, Smith L, Fusar-Poli P, Kurdyak PA, Fornaro M, Rehm J, Herrmann N. Evidence-based umbrella review of 162 peripheral biomarkers for major mental disorders. Transl Psychiatry. 2020 May 18;10(1):152. doi: 10.1038/s41398-020-0835-5.
- Background: PubMed 32609982Carvalho AF, Firth J, Vieta E. Bipolar Disorder. N Engl J Med. 2020 Jul 2;383(1):58-66. doi: 10.1056/NEJMra1906193. No abstract available.
- Background: PubMed 21262417Fiedorowicz JG, He J, Merikangas KR. The association between mood and anxiety disorders with vascular diseases and risk factors in a nationally representative sample. J Psychosom Res. 2011 Feb;70(2):145-54. doi: 10.1016/j.jpsychores.2010.07.010. Epub 2010 Sep 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduard Vieta principal investigator
Hospital Clinic of Barcelona
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Major Depressive Disorder, run by Alcediag at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Denmark, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performances of EDIT-B signatures on MDD vs. BD differentiation in patients with depression. (time frame: Specimen collection needed for evaluation of diagnostic performances: 1 day (= 1 visit).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05603819, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.