RecruitingPhase 2NCT06136546

Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab

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.


Sponsor

Massachusetts General Hospital

Enrollment

100 participants

Start Date

Jan 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 25 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether giving a single infusion of infliximab — a drug that blocks an inflammatory protein called TNF-alpha — can improve thinking and memory problems (cognitive dysfunction) in people with major depression who also have high levels of inflammation in their blood. The study aims to understand the link between brain inflammation and depression-related cognitive difficulties. **You may be eligible if...** - You are 25 to 50 years old with a confirmed diagnosis of major depressive disorder - Your depression is at least moderate severity - Your blood shows an elevated inflammatory marker (CRP ≥ 3 mg/L) - You are either medication-free or on a stable antidepressant regimen for at least 4 weeks - You are willing to receive an IV infusion and have blood drawn **You may NOT be eligible if...** - You have a current or recent serious infection, chronic infection (HIV, hepatitis B/C), or active COVID-19 symptoms - You have a history of cancer, autoimmune disease, organ transplant, or severe liver problems - You are currently taking antipsychotics, anticonvulsants, or corticosteroids - You have bipolar disorder or a history of psychosis - You have significant suicidal ideation - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGInfliximab

Intravenous infusion of infliximab

OTHERPlacebo

Intravenous infusion of saline solution (matching in color and consistency in infliximab)


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06136546


Related Trials