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Scientists trigger immune response to uncover Depression's brain secrets

NCT ID NCT04751331

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Recruiting now This study
This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how the immune system and brain talk to each other in people with major depression. Researchers will give a harmless substance (LPS) to temporarily activate the immune system and then measure brain activity and mood changes. The goal is to understand the links between inflammation, brain circuits, and depression symptoms. 180 adults (half with depression, half healthy) will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Laureate Institute for Brain Research

    RECRUITING

    Tulsa, Oklahoma, 74136, United States

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Other studies related to the condition(s) this trial covers.