Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT04751331

Neural Response to Inflammatory Challenge in Major Depressive Disorder

Led by Laureate Institute for Brain Research, Inc. · Updated on 2026-04-21

180

Participants Needed

1

Research Sites

289 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Neural Response to Inflammatory Challenge in Major Depressive Disorder

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be in good general health as evaluated during the first visit, including EKG
  • Participants must be between 18 and 65 years old
  • Depressed participants must have a DSM-V diagnosis of MDD confirmed by the MINI International Neuropsychiatric Interview
  • Depressed participants must have current symptoms of depression with a PHQ-9 score of 10 or higher and/or a MADRS score of 7 or higher
  • Healthy controls must have no personal history of psychiatric illness and be in good general health
  • Depressed participants must be unmedicated for at least 4 weeks (8 weeks for fluoxetine) or on only one antidepressant medication
Not Eligible

You will not qualify if you...

  • Pregnancy
  • History of fainting during blood draws as evaluated by clinical team
  • Moderate to severe traumatic brain injury or other neurocognitive disorder with neurological deficits
  • Co-morbid medical conditions like cardiovascular or neurological diseases, and pain disorders
  • Co-morbid inflammatory or autoimmune disorders such as rheumatoid arthritis
  • Uncontrolled medical conditions interfering with study or causing undue risk
  • Chronic infection elevating pro-inflammatory cytokines
  • Acute infectious illness or vaccination within two weeks before experimental session
  • Severe suicidal ideation or suicide attempt within past 12 months
  • Psychosis or bipolar disorder
  • Substance abuse or dependence within past 6 months
  • Contraindications for MRI including metal implants, pacemakers, shrapnel, previous neurosurgery, severe claustrophobia, and related conditions
  • Current or past regular use of hormone-containing medications (excluding contraceptives)
  • Use of immunosuppressive medications like corticosteroids
  • Use of non-steroid anti-inflammatory drugs more than 3 days per week if confounding
  • Use of immune-modifying drugs targeting specific immune responses
  • Current use or history of addiction to opioids or other analgesics
  • Current or past regular use of cardiovascular medications unless for other purposes
  • Chronic use of antibiotics affecting microbiome or immune function
  • Positive urine drug test for recreational drugs
  • Lifetime use of methamphetamine
  • BMI greater than 35
  • Clinically significant abnormalities on screening labs
  • Abnormal EKG findings
  • Vital signs outside specified safe ranges at screening
  • Non-English speaking participants

AI-Screening

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Trial Site Locations

Total: 1 location

1

Laureate Institute for Brain Research

Tulsa, Oklahoma, United States, 74136

Actively Recruiting

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Research Team

J

Jonathan Savitz, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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