Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136546
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-11-13
Brief Title:
Cognitive Dysfunction and Inflammation in Depression Experimental Inhibition Via Infliximab
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
The Role of Inflammation in Cognitive Dysfunction in Acute Depression as Determined by Experimental Inhibition of Tumor Necrosis Factor-alpha Signaling in a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
This study is a mechanistic randomized controlled trial that investigates whether inhibition of tumor necrosis factor signaling via intravenous infusion of infliximab improves psychomotor speed and executive functioning in depressed individuals who exhibit an inflammatory phenotype
Detailed Description:
In this mechanistic RCT depressed adults who exhibit a pro-inflammatory phenotype C reactive protein 3mgL will be randomized on a 11 allocation to receive a TNF inhibitor infliximab or placebo Over a two-week follow-up participants will remotely complete brief daily assessments of depressive symptoms and psychomotor speedexecutive functioning using a mobile-based platform TestMyBrain in addition to in-person clinician-rated assessment of depressive symptom severity Hamilton Depression Rating Scale anhedonia Dimensional Anhedonia Rating Scale and more comprehensive computerized batteries assessing cognitive function TestMyBrain Blood will be drawn at baseline and week 1 to assess immune biomarkers C reactive protein tumor necrosis factor- alpha and its soluble receptors Specifically the study will determine whether randomization to infliximab is associated with improvement in psychomotor speed and executive function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None