Inflammation Clinical Trial
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.
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.
In this mechanistic RCT, depressed adults who exhibit a pro-inflammatory phenotype (C reactive protein ≥3mg/L) will be randomized on a 1:1 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 speed/executive 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. ;
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