Study of Infliximab to Improve Thinking Skills in Adults With Depression and Inflammation Aged 25 to 50

What this Trial Is About

Researchers are investigating whether blocking tumor necrosis factor signaling with infliximab, given through an intravenous infusion, can improve thinking speed and executive function in adults with major depressive disorder who show signs of inflammation. This randomized controlled trial focuses on adults aged 25 to 50 who have elevated C reactive protein levels and moderate depression. The study aims to better understand the role of inflammation in cognitive difficulties associated with depression. Participants are randomly assigned to receive either infliximab at a dose of 5 mg per kilogram or a saline placebo through an in-dwelling catheter. Over two weeks, participants will complete daily remote assessments of depression symptoms and cognitive function using a mobile platform called TestMyBrain, alongside in-person evaluations by clinicians. Blood samples will be collected at the start and after one week to measure inflammatory markers and tumor necrosis factor levels. Throughout the study, researchers will monitor changes in psychomotor speed and executive function, with primary outcomes measured repeatedly over two weeks. Secondary assessments include depression severity scales and blood levels of C reactive protein. Participants will be closely observed for safety and adherence to the protocol during this period. The trial is led by Massachusetts General Hospital and follows a triple-blinded design to ensure unbiased results.

Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab