RecruitingPhase 1 / Phase 2

Neural Response to Inflammatory Challenge in Major Depressive Disorder

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 10 visits, 4 visits
  • Time periods mentioned: 6 months
  • Procedures mentioned: Blood draws, Infusions, MRI scans, Injections, Questionnaires, Interviews, Heart tracing (ECG), Physical exams

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "MDD participants will complete up to 10 study visits (V1-V10) while the HCs will complete up to four visits (V1-V4)."
  • "A nurse will insert a catheter with a heparin lock into the non-dominant forearm for blood draws and a continuous saline flush, and one into the dominant forearm for LPS or saline administration."
  • "Vital signs will be assessed every 30 min post infusion of LPS/saline for the first 2 hours (and thereafter every hour)."
  • "Two hours post-infusion at the approximate peak of the inflammatory response, the participants will complete the same MRI scans as at baseline."
  • "Subject to the judgment of a physician, the participants will be discharged 6 hours post injection so that the total experimental procedure will take \~8 hours to complete."
  • "Participants return the following day (T24) and one week later (V4) for mood ratings, blood draws, and identical MRI sessions."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how a substance called LPS, which causes inflammation, affects the brain and the ability to feel pleasure. It is for adults with major depression and healthy adults without depression. Participants receive either LPS or salt water through a vein.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 65 years old.
  • Be in good general health, based on an exam and an EKG, a test of the heart's electrical activity.
  • Join as either a healthy volunteer or a person with major depression.
  • For the depression group: have major depression confirmed by an interview, plus a PHQ-9 symptom score of at least 10 or a MADRS score of at least 7.

Who can't join

  • Pregnancy or not speaking English. Fainting during blood draws may also rule you out after review by the study team.
  • A serious brain injury; certain brain, heart, blood vessel, or pain conditions; an illness in which the immune system attacks the body; or an uncontrolled condition that makes the study unsafe.
  • A long-term infection that may raise inflammation, or an infection or vaccine within two weeks before a study session.
  • Current severe thoughts of suicide, a suicide attempt in the past year, psychosis, bipolar disorder, or drug or alcohol abuse or dependence in the past six months.
  • Problems that prevent a safe MRI brain scan, such as certain metal implants or fragments, past brain surgery, severe fear of enclosed spaces, or inability to lie still on your back for 60 minutes. Other MRI safety rules also apply.
  • Use of certain hormone, immune, inflammation, heart, blood pressure, pain, or long-term antibiotic medicines. Some past use also counts. Birth control is allowed; the team reviews other medicines and supplements.
  • Any past methamphetamine use, a urine test showing recreational drug use, or a history of addiction to opioids or other pain medicines.
  • BMI over 35, a measure of weight compared with height; important abnormal lab or heart test results; or, on arrival, blood pressure outside 100–140/60–90, pulse below 50 or above 100, or temperature above 99.5°F.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Both healthy controls and depressed participants will be required to be in good general health (as evaluated during Visit 1, including EKG) and to be 18-65 years of age. A DSM-V diagnosis of MDD will be made with the MINI International Neuropsychiatric Interview and current symptoms of depression will be measured with the clinician-administered MADRS and the self-report PHQ-9. Depressed participants will be required to have symptoms of depression (i.e. a PHQ-9 score ≥10) and/or a MADRS score of ≥7. Exclusion Criteria: General Exclusion Criteria: * Pregnancy * A history of fainting during blood draws will be evaluated by the clinical team and may be deemed exclusionary. Medical Conditions: * Moderate to severe traumatic brain injury (\>30 min. loss of consciousness or \>24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits. * 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 Contraindications for MRI: * Cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a professional metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60 minutes; prior neurosurgery; tattoos or cosmetic makeup with metal dyes, unwillingness to remove body piercings, and pregnancy. * Claustrophobia that is severe enough to preclude MRI scanning. Medications: * Current and/or past regular use of hormone-containing medications (excluding contraceptives) * Use of medications such as oral corticosteroids which may have immunosuppressive effects. * Current use of non-steroid anti-inflammatory drugs that is deemed by the investigators to potentially confound the results of the study (e.g. \> 3 days/week) * 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). * Chronic use of antibiotics such as isotretinoin or minocycline because of their potential effects on the microbiome and immune function. * Evidence of recreational drug use from urine test. * Lifetime use of methamphetamine * Inclusion of individuals reporting other types of medications or supplements not listed or considered thus far will be at the discretion of the PI based on their potential to affect immune function, the microbiome, brain function or brain blood flow. 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: 1. screening supine systolic blood pressure \>140 mmHg or \<100 mmHg 2. screening supine diastolic blood pressure \>90 mmHg or \<60 mmHg 3. 12-lead EKG demonstrating a PR interval \> 0.2 msec QTc \>450 or QRS \>120 msec (Bazett) 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 4. pulse less than 50 beats/minute or greater than 100 beats/minute 5. temperature greater than 99.5 degrees F. 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.

Study sites (1)

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