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Study identifier: NCT04751331 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Neural Response to Inflammatory Challenge in Major Depressive Disorder

Condition: Major Depressive Disorder  ·  Sponsor: Laureate Institute for Brain Research, Inc.

PhasePhase 1/Phase 2
Planned participants180
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersYes

About this study

This is a parallel group, double-blinded, placebo-controlled study. Participants with MDD (n=90) and HC (n=90) will be randomly assigned (2:1) to receive either lipopolysaccharide (LPS) (0.8ng/kg of body weight) or placebo (same volume of 0.9% saline) administered as an intravenous bolus. This will yield the following groups: MDD-LPS (n=60), MDD-Placebo (n=30), HC-LPS (n=60), HC-placebo (n=30). There are three main aims: to identify immune pathways and neural circuits that respond differently to LPS in MDD vs. HC subjects; (2) to test whether the strength of inflammatory changes induced by LPS is associated with degree of change in anhedonic symptoms and neural circuits in the MDD group, and (3) to identify a biotype of MDD that shows a differential immunological and neurophysiological response to LPS. The main outcome variables are symptoms of anhedonia measured with the Snaith-Hamilton Pleasure Scale (SHAPS), cytokines (Il-6, IL-8, IL-10, and TNF), and BOLD signal change in the neural circuitry mediating interoceptive processing, i.e. the insula and cingulate cortex. The exploratory aim is to determine whether the acute inflammatory response to LPS can predict the clinical course of depression over a period of six months. The main outcome of this component of the study is self-reported depressive symptoms assessed with the QIDS-SR.

This description comes directly from the study's public registry record.

Talk to the study team

Jonathan Savitz, PhD  ·  918 502 5104  ·  jsavitz@laureateinstitute.org

Always discuss trial participation with your own doctor first.

Locations (1)

Laureate Institute for Brain ResearchTulsa, Oklahoma, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04751331