NCT03142919

Lipopolysaccharide (LPS) Challenge in Depression

Response to Inflammatory Challenge in Major Depressive Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Laureate Institute for Brain Research, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

LPS Challenge in Individuals with Major Depressive Disorder

Detailed description

The aim of this project is to understand the biological differences between two distinct subtypes of depression, patients with and without inflammation as defined by c-reactive protein (CRP). Using a double-blinded, parallel group, placebo-controlled design, participants will be phenotyped before and after a low-dose lipopolysaccharide (LPS) challenge designed to perturb the immune system and trigger a transient, mild inflammatory response. This experimental design will allow for the delineation of the homeostatic mechanisms underlying sensitivity to inflammation-related depression. Low-dose LPS has been used by multiple groups to safely induce transient inflammatory responses in humans.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
BIOLOGICAL	Lipopolysaccharide	Lipopolysaccharide (LPS) derived from E. Coli group O 113:H10:K negative
BIOLOGICAL	Placebo	Saline solution

Timeline

• Start date: 2017-09-07
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2017-05-08
• Last updated: 2025-07-02
• Results posted: 2025-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study