Bipolar DisorderSEM 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
A study testing EDIT-B test and EDIT-B test (without giving result) in people with Bipolar Disorder and Major Depressive Disorder, run by Alcediag at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Major Depressive Disorder
- What is being tested?
- EDIT-B test and EDIT-B test (without giving result)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 7 sitesFrance
- Study dates
- 3 Feb 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Benjamin Dubuc contact
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
CH Erstein
Erstein
Geraldine Pfleger, Dr, +33 3 90 64 21 46, geraldine.pfleger@ch-erstein.fr
Geraldine Pfleger, Dr
- Not yet recruiting
AP-HP Corentin Celton
Issy-les-Moulineaux
Nicolas Hoertel, Pr, +33 1 58 00 44 21, nicolas.hoertel@aphp.fr
Nicolas Hoertel, Pr
- Not yet recruiting
Etablissement Public de Santé Mentale (EPSM) 74
La Roche-sur-Foron
Rocco De Filippis, Pr, +33 749121443, defilippis-r@ch-epsm74.fr
Rocco De Filippis, Pr
- Recruiting
Clinique Villa des Roses
Lyon
Pascal Frilloux, Dr, +33 4 78 15 00 00, pascal.frilloux-ext@inicea.fr
Pascal Frilloux, Dr
- Recruiting
Clinique Le Clos Montaigne
Montrond-les-Bains
Christophe Aimo, Dr, +33 4 77 36 01 00, christophe.aimo@inicea.fr
Christophe Aimo, Dr
- Recruiting
GHU Paris Psychiatrie et Neurosciences
Paris
Juan Zambrano, +33145658153, juan.zambrano@ghu-paris.fr
Chantal Henry, Pr
- Not yet recruiting
Clinique Médicale de Ville d'Avray
Ville-d'Avray
Jérôme Dischamps, +33147094314, jdischamps@wanadoo.fr
Jérôme Dischamps
About this study
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.
Read more
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.
- Conditions
- Bipolar Disorder, Major Depressive Disorder
- Being tested
- EDIT-B test, EDIT-B test (without giving result)
- Keywords
- Clinical Utility, Bipolar Disorder, Major Depressive Disorder
- 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-B testDiagnostic test
EDIT-B® is the first blood test for the differential diagnosis of bipolar disorder (BD) and major depression. It consists of a biological analysis (including targeted RNA sequencing) followed by a software interpretation thanks to an algorithm developed with AI. The test is CE marked, clinically validated on two independent cohorts and shows an excellent performance with a sensitivity and specificity of more than 80%.
For performing the test, a blood sample of 2.5 ml will be drawn using PAXgene™ Blood RNA tubes (Becton Dickinson, UK) according to the manufacturer's instructions.
The objective of EDIT-B® is to reduce the time to diagnosis of BD, which is currently 7 years on average. This will improve the patient pathway, thanks to faster access to appropriate care - whether for unipolar or bipolar patients - with a major medical, social and financial impact.
EDIT-B test (without giving result)Diagnostic test
EDIT-B® is the first blood test for the differential diagnosis of bipolar disorder (BD) and major depression. It consists of a biological analysis (including targeted RNA sequencing) followed by a software interpretation thanks to an algorithm developed with AI. The test is CE marked, clinically validated on two independent cohorts and shows an excellent performance with a sensitivity and specificity of more than 80%.
For performing the test, a blood sample of 2.5 ml will be drawn using PAXgene™ Blood RNA tubes (Becton Dickinson, UK) according to the manufacturer's instructions. THE RESULT OF THE TEST WILL NOT BE GIVEN TO THE PARTICIPANT BEFORE THE END OF THE STUDY.
The objective of EDIT-B® is to reduce the time to diagnosis of BD, which is currently 7 years on average. This will improve the patient pathway, thanks to faster access to appropriate care - whether for unipolar or bipolar patients - with a major medical, social and financial impact.
| Study group | Role | What they receive |
|---|---|---|
| With EDIT-B test result | Experimental | The investigator will have the EDIT-B® test result to guide the treatment strategy. Receives: Diagnostic Test: EDIT-B test |
| Without EDIT-B test result | Placebo 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. Receives: Diagnostic Test: EDIT-B test (without giving result) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in depressive symptoms between inclusion and 15-16 weeks visit.
Clinically meaningful improvement at week 15-16 in depressive symptoms, defined as a 6-point or greater reduction in MADRS total score from baseline, without a manic switch, defined as an increase in the YMRS total score above 11 from baseline, measured using a composite endpoint.
Measured: 4 months (from inclusion visit to 15-16 weeks visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start3 Feb 2025
- Primary completionApr 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alcediag
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507787
- Sponsor's protocol ID
- SEM EDIT-B
- Acronym
- SEM EDIT-B
- Status last verified
- Nov 2026
- First submitted
- 12 Jul 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06507787
- Acronym / sponsor ID
- SEM EDIT-B / SEM EDIT-B
- Conditions
- Bipolar Disorder, Major Depressive Disorder
- Keywords
- Clinical Utility, Bipolar Disorder, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- AlcediagIndustry (pharma, biotech, devices)
- 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
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 18 Jul 2024 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With EDIT-B test result | Experimental | Diagnostic Test: EDIT-B testThe investigator will have the EDIT-B® test result to guide the treatment strategy. |
| Without EDIT-B test result | Placebo comparator | Diagnostic Test: EDIT-B test (without giving result)The investigator will not have the EDIT-B® test result, but EDIT-B® is still performed on participants in the beginning of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
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-B testEDIT-B® is the first blood test for the differential diagnosis of bipolar disorder (BD) and major depression. It consists of a biological analysis (including targeted RNA sequencing) followed by a software interpretation thanks to an algorithm developed with AI. The test is CE marked, clinically validated on two independent cohorts and shows an excellent performance with a sensitivity and specificity of more than 80%. For performing the test, a blood sample of 2.5 ml will be drawn using PAXgene™ Blood RNA tubes (Becton Dickinson, UK) according to the manufacturer's instructions. The objective of EDIT-B® is to reduce the time to diagnosis of BD, which is currently 7 years on average. This will improve the patient pathway, thanks to faster access to appropriate care - whether for unipolar or bipolar patients - with a major medical, social and financial impact. | Diagnostic test | With EDIT-B test result |
| EDIT-B test (without giving result)EDIT-B® is the first blood test for the differential diagnosis of bipolar disorder (BD) and major depression. It consists of a biological analysis (including targeted RNA sequencing) followed by a software interpretation thanks to an algorithm developed with AI. The test is CE marked, clinically validated on two independent cohorts and shows an excellent performance with a sensitivity and specificity of more than 80%. For performing the test, a blood sample of 2.5 ml will be drawn using PAXgene™ Blood RNA tubes (Becton Dickinson, UK) according to the manufacturer's instructions. THE RESULT OF THE TEST WILL NOT BE GIVEN TO THE PARTICIPANT BEFORE THE END OF THE STUDY. The objective of EDIT-B® is to reduce the time to diagnosis of BD, which is currently 7 years on average. This will improve the patient pathway, thanks to faster access to appropriate care - whether for unipolar or bipolar patients - with a major medical, social and financial impact. | Diagnostic test | Without EDIT-B test result |
Primary outcome
Improvement in depressive symptoms between inclusion and 15-16 weeks visit.
Time frame: 4 months (from inclusion visit to 15-16 weeks visit)
Clinically meaningful improvement at week 15-16 in depressive symptoms, defined as a 6-point or greater reduction in MADRS total score from baseline, without a manic switch, defined as an increase in the YMRS total score above 11 from baseline, measured using a composite endpoint.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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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.
Benjamin Dubuc contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDIT-B test and EDIT-B test (without giving result) in people with Bipolar Disorder and Major Depressive Disorder, run by Alcediag at 7 sites in France.
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 14 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Menhem, PharmD, MSc (+33788970700, mary.menhem@alcediag-alcen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in depressive symptoms between inclusion and 15-16 weeks visit. (time frame: 4 months (from inclusion visit to 15-16 weeks visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.