Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306209
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-27
Brief Title:
Inflammatory Control of Antidepressant Efficacy a Pharmaco-epigenetic Approach
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Inflammatory Control of Antidepressant Efficacy a Pharmaco-epigenetic Approach
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
Major depressive disorder MDD is a chronic recurring and potentially life-threatening illness that affects up to 10 of the population across the globeIt posits that the increase in serotonin levels induced by Selective Serotonin Reuptake Inhibitors SSRIs does not affect mood per se but enhances brain plasticity and thus amplifies the influence of the environment on the individual Thus SSRI treatment has not a univocal effect but in a favorable environment it would lead to a reduction of symptoms while in a stressful environment might lead to a worse prognosisSuch innovative view opens new perspectives on how to improve SSRI efficacy by controlling the environment However often it is not possible to act on the quality of the living environment because of constraints due to patients personal history and unchangeable life circumstances In these cases the pharmacological modulation of the factors underlying the link between living environment and SSRI efficacy represents a novel and desirable strategy to improve treatment outcome even in patients living in adverse conditions which are very common in depressed patients Inflammatory levels are markedly affected by the socioeconomic status and thus by the quality of the living environment The hypothesis of the present project is that inflammation mediates the influence of the environment on SSRI outcomeTherefore the control of inflammatory levels is a promising strategy to improve treatment efficacy and overcome the limited SSRI efficacy especially when administered in patients living in adverse conditions A further hypothesis is that the influence of the environment on inflammation in turn affecting SSRI efficacy occurs through epigenetic modifications Therefore the project aims at developing a pharmaco-epigenetic approach as effective treatment for MDD In addition through neuroimaging investigations it will provide important information about functional and structural brain modifications associated to SSRI efficacy in patients
Both males and females will be considered because MDD is twice as common in women than men suggesting that different mechanisms may underlie the psychopathology in the two sexes
Both males and females will be considered because MDD is twice as common in women than men suggesting that different mechanisms may underlie the psychopathology in the two sexes
Detailed Description:
None
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