Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder
NCT Number: NCT06532604
Acronym: MESANTIDEP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Major Depressive Disorder
Interventions: DEVICE: Electroretinography (ERG)
Sponsor: Centre Psychothérapique de Nancy
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 108
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2026-07-01
Locations: Centre Psychothérapique de Nancy, Laxou, Nancy, 54520, France

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. 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.

Primary Outcome Measures: ERG amplitudes at baseline, Modification of amplitude measured with flash, pattern and multifocal electroretinogram amplitude in microvolt, Baseline (D0)|ERG implicit times at baseline, Modification of implicit time measured with flash, pattern and multifocal electroretinogram implicit time in millisecond, 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)., Baseline (D0) and 12 weeks after baseline (W12)
Secondary Outcome Measures: ERG amplitudes, Modification of amplitude measured with flash, pattern and multifocal electroretinogram amplitude in microvolt, Baseline (D0)|ERG amplitudes, Modification of amplitude measured with flash, pattern and multifocal electroretinogram amplitude in microvolt, 6 weeks after baseline (W6)|ERG amplitudes, Modification of amplitude measured with flash, pattern and multifocal electroretinogram amplitude in microvolt, 12 weeks after baseline (W12)|ERG implicit time, Modification of implicit time measured with flash, pattern and multifocal electroretinogram implicit time in millisecond, Baseline (D0)|ERG implicit time, Modification of implicit time measured with flash, pattern and multifocal electroretinogram implicit time in millisecond, 6 weeks after baseline (W6)|ERG implicit time, Modification of implicit time measured with flash, pattern and multifocal electroretinogram implicit time in millisecond, 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)., Baseline (D0) and 12 weeks after baseline (W12)|Montgomery Asberg Depression Rating Scale (MADRS) score differences, Differences in MADRS scores, Baseline (D0) and 6 weeks after baseline (W6)|Montgomery Asberg Depression Rating Scale (MADRS) score differences, Differences in MADRS scores, 6 weeks after baseline (W6) and 12 weeks after baseline (W12)
Other Outcome Measures: Alcohol Use DIsorders Test (AUDIT), A questionnaire rating consumption of alcoholic drinks, Baseline (D0)|Fagerström test, A questionnaire rating cigarette consumption, Baseline (D0)|Montgomery-Asberg Depression Rating Scale (MADRS) self, An auto-rating scale measuring depressive symptoms, Baseline (D0)|Montgomery-Asberg Depression Rating Scale (MADRS) self, An auto-rating scale measuring depressive symptoms, 6 weeks after baseline (W6)|Montgomery-Asberg Depression Rating Scale (MADRS) self, An auto-rating scale measuring depressive symptoms, 12 weeks after baseline (W12)|Hamilton Anxiety Rating Scale (HAM-A), A questionnaire rating level of anxiety, Baseline (D0)|Hamilton Anxiety Rating Scale (HAM-A), A questionnaire rating level of anxiety, 6 weeks after baseline (W6)|Hamilton Anxiety Rating Scale (HAM-A), A questionnaire rating level of anxiety, 12 weeks after baseline (W12)|Geriatric Depression Scale (GDS), A questionnaire measuring depressive symptoms for patients over 65, Baseline (D0)|Geriatric Depression Scale (GDS), A questionnaire measuring depressive symptoms for patients over 65, 6 weeks after baseline (W6)|Geriatric Depression Scale (GDS), A questionnaire measuring depressive symptoms for patients over 65, 12 weeks after baseline (W12)|Medication Adherence Report Scale (MARS), A questionnaire assessing patients' adherence to antidepressants, Baseline (D0)|Medication Adherence Report Scale (MARS), A questionnaire assessing patients' adherence to antidepressants, 6 weeks after baseline (W6)|Medication Adherence Report Scale (MARS), A questionnaire assessing patients' adherence to antidepressants, 12 weeks after baseline (W12)|Pittsburgh Sleep Quality Index (PSQI), A questionnaire assessing the subjective quality of sleep during the past month, Baseline (D0)|Pittsburgh Sleep Quality Index (PSQI), A questionnaire assessing the subjective quality of sleep during the past month, 6 weeks after baseline (W6)|Pittsburgh Sleep Quality Index (PSQI), A questionnaire assessing the subjective quality of sleep during the past month, 12 weeks after baseline (W12)|Epworth sleepiness scale (ESS), A questionnaire assessing the daytime sleepiness, Baseline (D0)|Epworth sleepiness scale (ESS), A questionnaire assessing the daytime sleepiness, 6 weeks after baseline (W6)|Epworth sleepiness scale (ESS), A questionnaire assessing the daytime sleepiness, 12 weeks after baseline (W12)|Insomnia Severity Index (ISI), A questionnaire assessing the severity of insomnia, Baseline (D0)|Insomnia Severity Index (ISI), A questionnaire assessing the severity of insomnia, 6 weeks after baseline (W6)|Insomnia Severity Index (ISI), A questionnaire assessing the severity of insomnia, 12 weeks after baseline (W12)