Lipopolysaccharide (LPS) Challenge in Depression

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    100
  • sponsor
    Laureate Institute for Brain Research, Inc.
Updated on 5 September 2021
depression
depressive symptoms
depressed mood
major depressive disorder
fluoxetine

Summary

LPS Challenge in Individuals with Major Depressive Disorder

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. The pilot study is expected to take approximately one year to complete.

Details
Condition Major depression, Endogenous depression, major depressive disorder, major depressive disorders
Treatment Placebo, Lipopolysaccharide
Clinical Study IdentifierNCT03142919
SponsorLaureate Institute for Brain Research, Inc.
Last Modified on5 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Depressed participants will be required to be in good general health (as
evaluated during Visit 1, including EKG) and to be 18-55 years of age
Depressed participants will be required to have symptoms of depression (i.e. a
PHQ-9 score 10) and be unmedicated for at least 3 weeks (8 weeks for
fluoxetine) or treated with only one anti-depressant medication. Half the
depressed participants (N=50) will be required to have a high-sensitivity
C-Reactive Protein (CRP) score of 3 mg/L, and half the participants will be
required to have a CRP score of 1 mg/L

Exclusion Criteria

Pregnancy
Previous history of fainting during blood draws
Medical Conditions
A history of a head injury with loss of consciousness
Presence of co-morbid medical conditions not limited to but including cardiovascular (e.g., history of acute coronary event, stroke) and neurological diseases (e.g., Parkinson's disease), as well as pain disorders
Presence of co-morbid inflammatory disorders such as rheumatoid arthritis or other autoimmune disorders
Presence of an uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or to put the study participant at undue risk
Presence of chronic infection that may elevate pro-inflammatory cytokines
Presence of an acute infectious illness or receipt of a vaccination in the two weeks prior to an experimental session
Psychiatric Disorders
Current severe suicidal ideation or attempt within the past 12 months
Psychosis
Bipolar disorder
Substance abuse or dependence within the previous 6 months
Age of onset of depression >40 years
Contraindications for MRI
Severe claustrophobia
Bodily implants of unsafe paramagnetic materials such as pace-makers and aneurysm clips
Medications
Current and/or past regular use of hormone-containing medications (excluding contraceptives)
Current use of non-steroid anti-inflammatory drugs that is deemed by the investigators to potentially confound the results of the study
Current and/or past regular use of immune modifying drugs that target specific immune responses such as TNF antagonists
Current use of analgesics such as opioids or history of addiction to opioids or other analgesics
Current and/or past regular use of cardiovascular medications, including antihypertensive, antiarrhythmic, anti-anginal, and anticoagulant drugs (does not apply where medications are taken for different purpose e.g. anti-hypertensives for migraine)
Evidence of recreational drug use from urine test
Lifetime use of methamphetamine
Health Factors
BMI > 35 because of the effects of obesity on pro-inflammatory cytokine activity
Clinically significant abnormalities on screening laboratory tests
Abnormal EKG
In addition, participants who on arrival to the study, show any of the following symptoms will not be allowed to complete the study
screening supine systolic blood pressure >140 mmHg or <100 mmHg
screening supine diastolic blood pressure >90 mmHg or <60 mmHg
12-lead EKG demonstrating a PR interval > 0.2 msec, QTc >450 or QRS >120 msec If the QTc exceeds 450 msec, or QRS exceeds 120 msec, the EKG will be repeated 2 more times and the median value will be used
pulse less than 50 beats/minute or greater than 100 beats/minute
temperature greater than 99.5F
Non-English speaking participants
The majority of the assessments proposed for this study have not been translated from English, thus, non-English speaking volunteers will be excluded
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