Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452290
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-05
Brief Title:
PET Biomarker Study for Antidepressant Response Prediction in Major Depressive Disorder
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
PET Biomarker Study for Antidepressant Response Prediction in Major Depressive Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEPDEP
Brief Summary:
Major depressive disorder has a prevalence of 47 in the general population and is ranked as the leading cause of disability worldwide The efficacy of current antidepressants is limited as 50-60 of patients do not achieve a sufficient response to treatment 12 achieve only a partial response while 19-34 do not respond at all These uncertain clinical effects are only observed after several weeks of treatment For better patient management there is an urgent need to identify markers for predicting and monitoring therapeutic response
Psychiatrists at the Nancy Psychotherapeutic Center are about to launch a MESANTIDEP study in which they will evaluate the electroretinogram ERG as a biomarker for predicting and monitoring therapeutic response
The TEPDEP study described in this protocol would evaluate 18F-FDG brain PETCT as a biomarker for predicting antidepressant response in a treatment-naive patient population
It is planned to offer the PETCT study to patients included in the SSRI arm of the MesantiDEP study
The hypothesis of this study is that 18F-FDG PETCT could be a biomarker for predicting response to selective serotonin reuptake inhibitor SSRI antidepressants
Psychiatrists at the Nancy Psychotherapeutic Center are about to launch a MESANTIDEP study in which they will evaluate the electroretinogram ERG as a biomarker for predicting and monitoring therapeutic response
The TEPDEP study described in this protocol would evaluate 18F-FDG brain PETCT as a biomarker for predicting antidepressant response in a treatment-naive patient population
It is planned to offer the PETCT study to patients included in the SSRI arm of the MesantiDEP study
The hypothesis of this study is that 18F-FDG PETCT could be a biomarker for predicting response to selective serotonin reuptake inhibitor SSRI antidepressants
Detailed Description:
Major depressive disorder has a prevalence of 47 in the general population and is ranked as the leading cause of disability worldwide The efficacy of current antidepressants is limited as 50-60 of patients do not achieve a sufficient response to treatment 12 achieve only a partial response while 19-34 do not respond at all These uncertain clinical effects are only observed after several weeks of treatment For better patient management there is an urgent need to identify markers for predicting and monitoring therapeutic response
Psychiatrists at the Nancy Psychotherapeutic Center are about to launch a MESANTIDEP study in which they will evaluate the electroretinogram as a biomarker for predicting and monitoring therapeutic response
In the literature numerous studies have shown a pattern of carbohydrate hypometabolism characteristic of depression identified by 18F-FDG brain PETCT scans Cerebral metabolism patterns predictive of antidepressant response have also been demonstrated in some clinical trials with hypermetabolism of the anterior cingulate in responders and more severe hypometabolism of the anterior cingulate dorsolateral prefrontal cortex and premotor area in non-responders However the studies in the literature group together very heterogeneous populations with a large proportion of patients not naïve to antidepressant treatment
The TEPDEP study described in this protocol would evaluate Positons Eission Tomography PET with flurodeoxyglucose labelled with fluor-18 18F-FDG brain as a biomarker for predicting antidepressant response in a treatment-naive patient population
It is planned to offer the PETCT study to patients included in the SSRI arm of the MesantiDEP study
The hypothesis of this study is that 18F-FDG PETCT could be a biomarker for predicting response to selective serotonin reuptake inhibitor SSRI antidepressants
Psychiatrists at the Nancy Psychotherapeutic Center are about to launch a MESANTIDEP study in which they will evaluate the electroretinogram as a biomarker for predicting and monitoring therapeutic response
In the literature numerous studies have shown a pattern of carbohydrate hypometabolism characteristic of depression identified by 18F-FDG brain PETCT scans Cerebral metabolism patterns predictive of antidepressant response have also been demonstrated in some clinical trials with hypermetabolism of the anterior cingulate in responders and more severe hypometabolism of the anterior cingulate dorsolateral prefrontal cortex and premotor area in non-responders However the studies in the literature group together very heterogeneous populations with a large proportion of patients not naïve to antidepressant treatment
The TEPDEP study described in this protocol would evaluate Positons Eission Tomography PET with flurodeoxyglucose labelled with fluor-18 18F-FDG brain as a biomarker for predicting antidepressant response in a treatment-naive patient population
It is planned to offer the PETCT study to patients included in the SSRI arm of the MesantiDEP study
The hypothesis of this study is that 18F-FDG PETCT could be a biomarker for predicting response to selective serotonin reuptake inhibitor SSRI antidepressants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None