Massachusetts General Hospital
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 computeri…
Inclusion Criteria: 1. Aged 25-50 years 2. Able to read and understand English and willing to provide informed consent/comply with the study protocol 3. Willingness to complete intravenous infusion and have blood drawn 4. Exhibit circulating blood level of C reactive protein ≥ 3mg/L 5. Diagnosed with Major Depressive Disorder 6. Moderate depressive symptom severity, as indicated by score ≥15 on the Hamilton Depression Rating Scale 7. Antidepressant treatment free for at least 4 weeks prior to study entry or be on a fixed treatment regimen for at least 4 weeks; willingness to continue treatmen…
Intravenous infusion of infliximab
Intravenous infusion of saline solution (matching in color and consistency in infliximab)
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