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NCT Number: NCT06532604

Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Psychothérapique de Nancy

Laxou, Nancy, 54520, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

Electroretinography (ERG)

Device

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.

Other names: MonPackOneⓇ (Métrovision), RETevalⓇ (LKS technologie)

Primary outcomes

  1. ERG amplitudes at baseline

    Time frame: Baseline (D0)

    Modification of amplitude measured with flash, pattern and multifocal electroretinogram amplitude in microvolt

  2. ERG implicit times at baseline

    Time frame: Baseline (D0)

    Modification of implicit time measured with flash, pattern and multifocal electroretinogram implicit time in millisecond

  3. 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).

Secondary outcomes

  1. ERG amplitudes

    Time frame: Baseline (D0)

    Modification of amplitude measured with flash, pattern and multifocal electroretinogram amplitude in microvolt

  2. ERG amplitudes

    Time frame: 6 weeks after baseline (W6)

    Modification of amplitude measured with flash, pattern and multifocal electroretinogram amplitude in microvolt

  3. ERG amplitudes

    Time frame: 12 weeks after baseline (W12)

    Modification of amplitude measured with flash, pattern and multifocal electroretinogram amplitude in microvolt

  4. ERG implicit time

    Time frame: Baseline (D0)

    Modification of implicit time measured with flash, pattern and multifocal electroretinogram implicit time in millisecond

  5. ERG implicit time

    Time frame: 6 weeks after baseline (W6)

    Modification of implicit time measured with flash, pattern and multifocal electroretinogram implicit time in millisecond

  6. ERG implicit time

    Time frame: 12 weeks after baseline (W12)

    Modification of implicit time measured with flash, pattern and multifocal electroretinogram implicit time in millisecond

  7. Montgomery Asberg Depression Rating Scale (MADRS) score differences

    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).

  8. Montgomery Asberg Depression Rating Scale (MADRS) score differences

    Time frame: Baseline (D0) and 6 weeks after baseline (W6)

    Differences in MADRS scores

  9. Montgomery Asberg Depression Rating Scale (MADRS) score differences

    Time frame: 6 weeks after baseline (W6) and 12 weeks after baseline (W12)

    Differences in MADRS scores

Other outcomes

  1. Alcohol Use DIsorders Test (AUDIT)

    Time frame: Baseline (D0)

    A questionnaire rating consumption of alcoholic drinks

  2. Fagerström test

    Time frame: Baseline (D0)

    A questionnaire rating cigarette consumption

  3. Montgomery-Asberg Depression Rating Scale (MADRS) self

    Time frame: Baseline (D0)

    An auto-rating scale measuring depressive symptoms

  4. Montgomery-Asberg Depression Rating Scale (MADRS) self

    Time frame: 6 weeks after baseline (W6)

    An auto-rating scale measuring depressive symptoms

  5. Montgomery-Asberg Depression Rating Scale (MADRS) self

    Time frame: 12 weeks after baseline (W12)

    An auto-rating scale measuring depressive symptoms

  6. Hamilton Anxiety Rating Scale (HAM-A)

    Time frame: Baseline (D0)

    A questionnaire rating level of anxiety

  7. Hamilton Anxiety Rating Scale (HAM-A)

    Time frame: 6 weeks after baseline (W6)

    A questionnaire rating level of anxiety

  8. Hamilton Anxiety Rating Scale (HAM-A)

    Time frame: 12 weeks after baseline (W12)

    A questionnaire rating level of anxiety

  9. Geriatric Depression Scale (GDS)

    Time frame: Baseline (D0)

    A questionnaire measuring depressive symptoms for patients over 65

  10. Geriatric Depression Scale (GDS)

    Time frame: 6 weeks after baseline (W6)

    A questionnaire measuring depressive symptoms for patients over 65

  11. Geriatric Depression Scale (GDS)

    Time frame: 12 weeks after baseline (W12)

    A questionnaire measuring depressive symptoms for patients over 65

  12. Medication Adherence Report Scale (MARS)

    Time frame: Baseline (D0)

    A questionnaire assessing patients' adherence to antidepressants

  13. Medication Adherence Report Scale (MARS)

    Time frame: 6 weeks after baseline (W6)

    A questionnaire assessing patients' adherence to antidepressants

  14. Medication Adherence Report Scale (MARS)

    Time frame: 12 weeks after baseline (W12)

    A questionnaire assessing patients' adherence to antidepressants

  15. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline (D0)

    A questionnaire assessing the subjective quality of sleep during the past month

  16. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 6 weeks after baseline (W6)

    A questionnaire assessing the subjective quality of sleep during the past month

  17. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 12 weeks after baseline (W12)

    A questionnaire assessing the subjective quality of sleep during the past month

  18. Epworth sleepiness scale (ESS)

    Time frame: Baseline (D0)

    A questionnaire assessing the daytime sleepiness

  19. Epworth sleepiness scale (ESS)

    Time frame: 6 weeks after baseline (W6)

    A questionnaire assessing the daytime sleepiness

  20. Epworth sleepiness scale (ESS)

    Time frame: 12 weeks after baseline (W12)

    A questionnaire assessing the daytime sleepiness

  21. Insomnia Severity Index (ISI)

    Time frame: Baseline (D0)

    A questionnaire assessing the severity of insomnia

  22. Insomnia Severity Index (ISI)

    Time frame: 6 weeks after baseline (W6)

    A questionnaire assessing the severity of insomnia

  23. Insomnia Severity Index (ISI)

    Time frame: 12 weeks after baseline (W12)

    A questionnaire assessing the severity of insomnia

Study contacts

Contact information is provided by the study sponsor or research team.

De DEUS MARIE

CONTACT

[email protected]

03 83 92 67 01

Naoual MELLOUKI, PhD

CONTACT

[email protected]

0383925267

Sponsors and collaborators

Lead sponsor

Centre Psychothérapique de Nancy

Other

Registry information

Acronym: MESANTIDEP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 1, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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