Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306248
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-27
Brief Title:
Immune Activation Neural Plasticity and Depression
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Adjusting Immune Activation to Reinstate Neural Plasticity and Promote the Beneficial Effect of Non-pharmacological Interventions
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 globeIncreasing evidence indicates a clear link between immune dysfunction and MDDMoreover an activation of inflammatory pathways is associated to a lack of clinical response to antidepressants Thus the regulation of inflammation represents a potential approach to modulate the link between the living environment and antidepressant outcome Light therapy combined with sleep deprivation hastens recovery with benefits that can be perceived by patients during the first week of treatment Alteration of the sleep-wake cycle and of sleep structure are core symptoms of MDDThe aims of the present project are i to show that neural plasticity and the environmental context are moderating factors of the therapeutic outcome of immune modulation and ii to exploit their interplay to set up novel and effective therapeutic strategies for MDDThis is a observational prospective study with non-invasive add-on procedures Magnetic Resonance without contrast In this study 60 patients with a depressive episode in course of MDD and treated with a chronobiological intervention including total sleep deprivation TSD light therapy LT as performed in clinical practice will be studied All participants enrolled in the study will receive Treatment As Usual TAU ie pharmacotherapy chronobiological intervention plus clinical management Drug prescription will be performed during the clinical management sessionsThe study will have a total duration of 24 months Each subject will participate in the study for 6 months will undergo Magnetic Resonance Imaging MRI and clinical evaluation at baseline after one week of chronobiological treatment and at 6 months follow-up
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