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LPS for Major Depressive Disorder

Phase 1 & 2
Recruiting
Research Sponsored by Laureate Institute for Brain Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Depressed participants must have symptoms of depression (PHQ-9 score ≥10) and/or a MADRS score of ≥7
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing whether lipopolysaccharide (LPS) can help treat major depressive disorder (MDD). LPS is a molecule found on the outside of some types of bacteria. The trial will enroll 180 participants, 90 with MDD and 90 healthy controls (HC). Participants will be randomly assigned to receive either LPS or a placebo. The trial has 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

Who is the study for?
This trial is for adults aged 18-65 with Major Depressive Disorder (MDD) and healthy controls, both in good general health. MDD participants must have a PHQ-9 score ≥10 or MADRS score of ≥7. Exclusions include severe brain injury, certain medical conditions like heart disease, autoimmune disorders, uncontrolled illnesses that could affect the study or pose risks, recent infections or vaccinations, severe suicidal ideation within the past year, psychosis, substance abuse within six months, metal implants incompatible with MRI scans, pregnancy and others.Check my eligibility
What is being tested?
The study tests how an inflammatory challenge (LPS injection) affects individuals with MDD compared to healthy controls. It's double-blinded and placebo-controlled; some get LPS while others receive saline as a placebo. The focus is on immune response differences between groups and whether inflammation correlates with changes in pleasurelessness symptoms and specific neural circuits.See study design
What are the potential side effects?
Potential side effects from LPS may include flu-like symptoms such as fever, chills, headache or muscle pain due to induced inflammation. Since it's administered intravenously there might also be reactions at the injection site like redness or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with depression based on my PHQ-9 or MADRS scores.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Depressive Symptoms
Neural response to anticipation of monetary reward
Neural response to interoceptive vs exteroceptive stimuli (interoceptive awareness task)
+1 more
Other outcome measures
Course of Illness
Inflammatory response
Temperature

Side effects data

From 2016 Phase 4 trial • 16 Patients • NCT02875028
53%
headache
27%
Chills
13%
Myalgia
13%
malaise
7%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vorapaxar
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LPSExperimental Treatment1 Intervention
Lipopolysaccharide (LPS) (0.8ng/kg of body weight; E. coli group O:113) administered as an intravenous bolus.
Group II: PlaceboPlacebo Group1 Intervention
Placebo (same volume of 0.9% saline) administered as an intravenous bolus
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LPS
2018
Completed Phase 4
~230

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor
50 Previous Clinical Trials
5,165 Total Patients Enrolled
17 Trials studying Depression
2,477 Patients Enrolled for Depression

Media Library

LPS (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04751331 — Phase 1 & 2
Depression Research Study Groups: LPS, Placebo
Depression Clinical Trial 2023: LPS Highlights & Side Effects. Trial Name: NCT04751331 — Phase 1 & 2
LPS (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04751331 — Phase 1 & 2
Depression Patient Testimony for trial: Trial Name: NCT04751331 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are actively engaged in this clinical research project?

"Affirmative. Records from clinicaltrials.gov indicate that this research initiative, which was initially created on May 15th 2021, is still seeking participants. This medical trial requires 180 individuals across 1 site to partake in the study."

Answered by AI

Who satisfies the criteria for enrollment in this medical experiment?

"This medical trial seeks 180 individuals suffering from MDD and aged between 18 to 65. In order to qualify, applicants must meet these two criteria."

Answered by AI

Is the eligibility criteria for this research inclusive of individuals over 40 years old?

"The eligibility criteria for this medical trial requires that participants be over the age of consent and under 65 years old."

Answered by AI

Are medical centers currently accepting enrollees for this experiment?

"Affirmative. Details on clinicaltrials.gov indicate that this medical experiment is actively recruiting participants, with 180 individuals needed from a single site. The trial was first posted May 15th 2021 and last modified June 29th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
How old are they?
18 - 65
What site did they apply to?
Laureate Institute for Brain Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Have tried every prescription that medically approved through my VA and still nothing has helped to the point of not being effected by my MDD to even socialize with family or friends and have a plethora of emotions that keep me isolated alone scared and at in some instances with SI.
PatientReceived 2+ prior treatments
~76 spots leftby Apr 2026