A Randomized Controlled Trial of the Tumor Necrosis Factor-alpha Antagonist Infliximab in Treatment Resistant Depression: Role of Baseline Inflammatory Biomarkers
Abstract
Context Increased inflammatory biomarkers predict antidepressant non-response, and inflammatory cytokines can sabotage and circumvent mechanisms of action of conventional antidepressant therapy. Objective To determine whether inhibition of the inflammatory cytokine tumor necrosis factor (TNF)-alpha reduces depressive symptoms in patients with treatment resistant depression (TRD) and whether increased baseline plasma inflammatory biomarkers including high sensitivity c-reactive protein (hs-CRP), TNF-alpha and its soluble receptors predict treatment response. Design Double-blind, placebo-controlled, randomized clinical trial. Setting Outpatient infusion center, Emory University. Participants Sixty medically-stable outpatients with major depression on a consistent antidepressant regimen or medication-free (n=23) for ≥4 weeks and moderate treatment resistance as determined by the Massachusetts General Hospital Staging method. Interventions Three infusions of the TNF-alpha antagonist infliximab (5mg/kg)(n=30) or placebo (n=30) at baseline and weeks 2 and 6 of a 12-week trial. Main Outcome Measure 17-item Hamilton Depression Rating Scale (HAM-D-17). Results No overall difference in change of HAM-D-17 scores between treatment groups across time was found. However, there was a significant interaction between treatment, time and log baseline hs-CRP (p=0.01), with change in HAM-D-17 scores (Baseline to Week 12) favoring infliximab-treated patients at a baseline hs-CRP>5mg/L and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 30 participants or records.
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