Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder

Official 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 elect

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 108 participants

Interventions

• DEVICE: Electroretinography (ERG) — 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 respective

Primary Outcomes

• ERG amplitudes at baseline (Baseline (D0))
• ERG implicit times at baseline (Baseline (D0))
• Montgomery Asberg Depression Rating Scale score differences between D0 and W12 (Baseline (D0) and 12 weeks after baseline (W12))

Secondary Outcomes

• ERG amplitudes (Baseline (D0))
• ERG amplitudes (6 weeks after baseline (W6))
• ERG amplitudes (12 weeks after baseline (W12))
• ERG implicit time (Baseline (D0))
• ERG implicit time (6 weeks after baseline (W6))

Trial Locations

• Centre Psychothérapique de Nancy, Laxou, Nancy, France

More Major Depressive Disorder Trials

View all Major Depressive Disorder clinical trials