Major Depressive DisorderMESANTIDEPNCT06532604
Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder
A study testing Electroretinography (ERG) in people with Major Depressive Disorder, run by Centre Psychothérapique de Nancy at 1 site in France.
Trial summary
Major depressive disorder (MDD) is a frequent and particularly disabling disorder. The efficacy of current antidepressants is limited, with 50-60% of patients not achieving a sufficient response to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Electroretinography (ERG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of a current unipolar depressive episode according to DSM-V criteria
- Prescription of antidepressant treatment - SSRI or alpha-2 antagonist - by the psychiatrist or referring physician for the current depressive episode
- Age 18 or more
- Affiliation with a welfare scheme and native French speakers
- Complete information on the study received and written informed consent signed
Who cannot join
- Diagnosis of a progressive psychiatric disorder (except MDD and anxiety disorder) according to DSM-V criteria
- Seasonal character of the depression
- Current antidepressant treatment
- Recommended antidepressant treatment other than SSRI or alpha-2 antagonist
- High suicide risk
- Retinal or ophtalmologic pathology affecting visual acuity as assessed by the Monoyer scale.
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- History of head trauma, epilepsy or other neurological disorders
- Participation in another interventional study (including exclusion period)
- Intellectual disability leading to difficulty participating or impossibility or inability to understand the information provided on the study.
- Persons cited in Articles L. 1121-5 to L. 1121-8 of the French Public Health Code: pregnant women, parturient or breastfeeding mothers, persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under duress, persons admitted to a health or social establishment for other goals than research, minors, adults subject to a legal protection, adults who are unable to express their consent and who are not subject to a legal protection measure.
- Criteria incompatible with the use of the ERG device: open wound in an area covered or enveloped by the device; implantable medical device (e.g. pacemaker); user at high risk of contagion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Major depressive disorder (MDD) is a frequent and particularly disabling disorder. The efficacy of current antidepressants is limited, with 50-60% of patients not achieving a sufficient response to treatment. Indeed, to date, clinicians are unable to predict the therapeutic response a patient will obtain to a given molecule. This often results in several trials of a molecule until clinical efficacy is achieved, with a delay of several months of untreated disease. Achieving faster efficacy by targeting the right molecule for each patient in the 1st line of treatment would limit the morbidity and mortality induced by MDD, and its impact on quality of life. To achieve this goal rapidly, there is a need to identify markers for predicting and monitoring therapeutic response to antidepressants.
This is why the MESANTIDEP study aims to propose electroretinographic (ERG) biomarkers for predicting therapeutic response at 12 weeks for the two main therapeutic classes of antidepressants prescribed as 1st-line treatment for major depressive disorder: Selective Serotonin Reuptake Inhibitors (SSRIs) and alpha-2 adrenergic receptor antagonists (alpha-2 antagonists). Secondly, investigators will look for ERG biomarkers of therapeutic response at 6 weeks, and 12 weeks, for these two therapeutic classes of antidepressants.
For this purpose, patients diagnosed with MDD and requiring the initiation of an antidepressant - of the SSRI or alpha-2-antagonist class - will be included. At their inclusion visit, patients will not yet have started their antidepressant treatment and will undergo various tests. These include clinical questionnaires, sleep assessment questionnaires and three ERG tests (fERG, PERG and mfERG). Antidepressant treatment can be started by the patient the day after the inclusion visit. 6 and 12 weeks later, the patient undergoes the same tests as at the inclusion visit to monitor their therapeutic response to the prescribed antidepressant. The identification of electrophysiological markers predictive of therapeutic response to antidepressants is intended to help clinicians in the treatment of MDD patients. More rapid therapeutic intervention tailored to each patient will limit the functional impact, improve quality of life and reduce the morbidity and mortality associated with the disease. These electrophysiological ERG measurements are easy to perform. They are therefore accessible to all, and can be used, through a multimodal approach, in routine clinical practice.
- Conditions
- Major Depressive Disorder
- Being tested
- Electroretinography (ERG)
- Keywords
- Antidepressant, Electroretinography, Precision psychiatry, Selective Serotonin Reuptake Inhibitor, Alpha-2 adrenergic receptor antagonists, Retinal function
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroretinography (ERG)Device
Also called MonPackOneⓇ (Métrovision), RETevalⓇ (LKS technologie)
ERG are specifically carried out for research. They are performed in Nancy with the MonPackOne device developed by Metrovision for participants at center n°1, and in Paris with the RETeval device developed by LKS Technologie for participants at center n°2. Both devices comply with ISCEV standard and are CE marked. They enable the reccord of Pattern ERG, Flash ERG and Multifocal ERG using corneal and skin electrodes, or Sensor Strip skin electrodes only, for the Nancy and Paris centers respectively.
| Study group | Role | What they receive |
|---|---|---|
| SSRI treated patients | Experimental | MDD patients treated with Selective Serotonin Reuptake Inhibitors (SSRIs) the day after the inclusion visit. Receives: Device: Electroretinography (ERG) |
| Alpha-2 antagonists treated patients | Experimental | MDD patients treated with alpha-2 adrenergic receptor antagonists (alpha-2 antagonists) the day after the inclusion visit. Receives: Device: Electroretinography (ERG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ERG amplitudes at baseline
Modification of amplitude measured with flash, pattern and multifocal electroretinogram amplitude in microvolt
Measured: Baseline (D0)
ERG implicit times at baseline
Modification of implicit time measured with flash, pattern and multifocal electroretinogram implicit time in millisecond
Measured: Baseline (D0)
Montgomery Asberg Depression Rating Scale score differences between D0 and W12
A subject will be declared responder (decrease greater than or equal to 8 points between D0 and W12) or non-responder (score difference less than 8 points or increase between D0 and W12). We obtain binary data (responder/non-responder).
Measured: Baseline (D0) and 12 weeks after baseline (W12)
Secondary outcomes (9)
ERG amplitudes
Modification of amplitude measured with flash, pattern and multifocal electroretinogram amplitude in microvolt
Measured: Baseline (D0)
ERG amplitudes
Modification of amplitude measured with flash, pattern and multifocal electroretinogram amplitude in microvolt
Measured: 6 weeks after baseline (W6)
ERG amplitudes
Modification of amplitude measured with flash, pattern and multifocal electroretinogram amplitude in microvolt
Measured: 12 weeks after baseline (W12)
ERG implicit time
Modification of implicit time measured with flash, pattern and multifocal electroretinogram implicit time in millisecond
Measured: Baseline (D0)
ERG implicit time
Modification of implicit time measured with flash, pattern and multifocal electroretinogram implicit time in millisecond
Measured: 6 weeks after baseline (W6)
ERG implicit time
Modification of implicit time measured with flash, pattern and multifocal electroretinogram implicit time in millisecond
Measured: 12 weeks after baseline (W12)
Montgomery Asberg Depression Rating Scale (MADRS) score differences
A subject will be declared responder (decrease greater than or equal to 8 points between D0 and W12) or non-responder (score difference less than 8 points or increase between D0 and W12). We obtain binary data (responder/non-responder).
Measured: Baseline (D0) and 12 weeks after baseline (W12)
Montgomery Asberg Depression Rating Scale (MADRS) score differences
Differences in MADRS scores
Measured: Baseline (D0) and 6 weeks after baseline (W6)
Montgomery Asberg Depression Rating Scale (MADRS) score differences
Differences in MADRS scores
Measured: 6 weeks after baseline (W6) and 12 weeks after baseline (W12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- MESANTIDEP is a pilot, longitudinal, prospective and multicenter cohort study.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Psychothérapique de Nancy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Schwitzer Thomas, Pr, Principal investigator, Centre Psychothérapique de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532604
- Sponsor's protocol ID
- 2024-A00551-46
- Other IDs
- RIPH 2024-01
- Acronym
- MESANTIDEP
- Status last verified
- Mar 2026
- First submitted
- 29 Jul 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Deus M, Petit C, Moulard M, Cosker E, Mellouki Bendimred N, Albuisson E, Maruani J, Geoffroy PA, Schwitzer T. Exploring the ElectroRetinoGraphy as a biomarker for predicting and monitoring therapeutic response to antidepressants in major depressive disorder: study protocol for the MESANTIDEP trial. Front Psychiatry. 2025 Apr 25;16:1501166. doi: 10.3389/fpsyt.2025.1501166. eCollection 2025.
PubMed 40352365
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06532604
- Acronym / sponsor ID
- MESANTIDEP / 2024-A00551-46
- Conditions
- Major Depressive Disorder
- Keywords
- Antidepressant, Electroretinography, Precision psychiatry, Selective Serotonin Reuptake Inhibitor, Alpha-2 adrenergic receptor antagonists, Retinal function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Centre Psychothérapique de NancyUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 1 Aug 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.
Major depressive disorder (MDD) is a frequent and particularly disabling disorder. The efficacy of current antidepressants is limited, with 50-60% of patients not achieving a sufficient response to treatment. Indeed, to date, clinicians are unable to predict the therapeutic response a patient will obtain to a given molecule. This often results in several trials of a molecule until clinical efficacy is achieved, with a delay of several months of untreated disease. Achieving faster efficacy by targeting the right molecule for each patient in the 1st line of treatment would limit the morbidity and mortality induced by MDD, and its impact on quality of life. To achieve this goal rapidly, there is a need to identify markers for predicting and monitoring therapeutic response to antidepressants.
This is why the MESANTIDEP study aims to propose electroretinographic (ERG) biomarkers for predicting therapeutic response at 12 weeks for the two main therapeutic classes of antidepressants prescribed as 1st-line treatment for major depressive disorder: Selective Serotonin Reuptake Inhibitors (SSRIs) and alpha-2 adrenergic receptor antagonists (alpha-2 antagonists). Secondly, investigators will look for ERG biomarkers of therapeutic response at 6 weeks, and 12 weeks, for these two therapeutic classes of antidepressants.
For this purpose, patients diagnosed with MDD and requiring the initiation of an antidepressant - of the SSRI or alpha-2-antagonist class - will be included. At their inclusion visit, patients will not yet have started their antidepressant treatment and will undergo various tests. These include clinical questionnaires, sleep assessment questionnaires and three ERG tests (fERG, PERG and mfERG). Antidepressant treatment can be started by the patient the day after the inclusion visit. 6 and 12 weeks later, the patient undergoes the same tests as at the inclusion visit to monitor their therapeutic response to the prescribed antidepressant. The identification of electrophysiological markers predictive of therapeutic response to antidepressants is intended to help clinicians in the treatment of MDD patients. More rapid therapeutic intervention tailored to each patient will limit the functional impact, improve quality of life and reduce the morbidity and mortality associated with the disease. These electrophysiological ERG measurements are easy to perform. They are therefore accessible to all, and can be used, through a multimodal approach, in routine clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- MESANTIDEP is a pilot, longitudinal, prospective and multicenter cohort study.
| Arm | Type | Receives |
|---|---|---|
| SSRI treated patients | Experimental | Device: Electroretinography (ERG)MDD patients treated with Selective Serotonin Reuptake Inhibitors (SSRIs) the day after the inclusion visit. |
| Alpha-2 antagonists treated patients | Experimental | Device: Electroretinography (ERG)MDD patients treated with alpha-2 adrenergic receptor antagonists (alpha-2 antagonists) the day after the inclusion visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of a current unipolar depressive episode according to DSM-V criteria
- Prescription of antidepressant treatment - SSRI or alpha-2 antagonist - by the psychiatrist or referring physician for the current depressive episode
- Age 18 or more
- Affiliation with a welfare scheme and native French speakers
- Complete information on the study received and written informed consent signed
Key exclusion criteria (11 listed)
- Diagnosis of a progressive psychiatric disorder (except MDD and anxiety disorder) according to DSM-V criteria
- Seasonal character of the depression
- Current antidepressant treatment
- Recommended antidepressant treatment other than SSRI or alpha-2 antagonist
- High suicide risk
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 |
|---|---|---|
| Electroretinography (ERG)Also: MonPackOneⓇ (Métrovision), RETevalⓇ (LKS technologie)ERG are specifically carried out for research. They are performed in Nancy with the MonPackOne device developed by Metrovision for participants at center n°1, and in Paris with the RETeval device developed by LKS Technologie for participants at center n°2. Both devices comply with ISCEV standard and are CE marked. They enable the reccord of Pattern ERG, Flash ERG and Multifocal ERG using corneal and skin electrodes, or Sensor Strip skin electrodes only, for the Nancy and Paris centers respectively. | Device | Alpha-2 antagonists treated patients, SSRI treated patients |
Primary outcome
ERG amplitudes at baseline
Time frame: Baseline (D0)
Modification of amplitude measured with flash, pattern and multifocal electroretinogram amplitude in microvolt
ERG implicit times at baseline
Time frame: Baseline (D0)
Modification of implicit time measured with flash, pattern and multifocal electroretinogram implicit time in millisecond
Montgomery Asberg Depression Rating Scale score differences between D0 and W12
Time frame: Baseline (D0) and 12 weeks after baseline (W12)
A subject will be declared responder (decrease greater than or equal to 8 points between D0 and W12) or non-responder (score difference less than 8 points or increase between D0 and W12). We obtain binary data (responder/non-responder).
9 secondary outcomes
ERG amplitudes
Time frame: Baseline (D0)
ERG amplitudes
Time frame: 6 weeks after baseline (W6)
ERG amplitudes
Time frame: 12 weeks after baseline (W12)
ERG implicit time
Time frame: Baseline (D0)
ERG implicit time
Time frame: 6 weeks after baseline (W6)
ERG implicit time
Time frame: 12 weeks after baseline (W12)
Montgomery Asberg Depression Rating Scale (MADRS) score differences
Time frame: Baseline (D0) and 12 weeks after baseline (W12)
Montgomery Asberg Depression Rating Scale (MADRS) score differences
Time frame: Baseline (D0) and 6 weeks after baseline (W6)
Montgomery Asberg Depression Rating Scale (MADRS) score differences
Time frame: 6 weeks after baseline (W6) and 12 weeks after baseline (W12)
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 27 Mar 2026.
- Derived from this study: PubMed 40352365de Deus M, Petit C, Moulard M, Cosker E, Mellouki Bendimred N, Albuisson E, Maruani J, Geoffroy PA, Schwitzer T. Exploring the ElectroRetinoGraphy as a biomarker for predicting and monitoring therapeutic response to antidepressants in major depressive disorder: study protocol for the MESANTIDEP trial. Front Psychiatry. 2025 Apr 25;16:1501166. doi: 10.3389/fpsyt.2025.1501166. eCollection 2025.
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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.
Schwitzer Thomas, Pr principal investigator
Centre Psychothérapique de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroretinography (ERG) in people with Major Depressive Disorder, run by Centre Psychothérapique de Nancy at 1 site 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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 De DEUS MARIE (03 83 92 67 01, Marie.DEDEUS@cpn-laxou.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ERG amplitudes at baseline (time frame: Baseline (D0)). The study lists 3 primary outcomes in all. 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 NCT06532604, which also lists 1 linked publication.
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 27 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.