Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532604
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of Electrophysiological Markers of Antidepressants in Major Depressive Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MESANTIDEP
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None