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Clinical Trial

Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder

NCT: NCT06532604 · NOT_YET_RECRUITING

NCT IDNCT06532604
StatusNOT_YET_RECRUITING
Start Date2026-09-01
Completion2028-03-01

Brief 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.

Frequently Asked Questions

What is Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder?

Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder is a clinical trial registered under NCT06532604. Current status: NOT_YET_RECRUITING.

What is the status of NCT06532604?

The current status of NCT06532604 (Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder) is: NOT_YET_RECRUITING.

When did Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder start?

Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder started on 2026-09-01.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.