← Back to Search

Neuroimmune Imaging for PTSD

Phase 1
Waitlist Available
Led By Kelly Cosgrove, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with PTSD will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis)
Men and women, aged 18-55 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before lps administration
Awards & highlights

Study Summary

This trial will study individuals with and without PTSD to see if there is a difference in the neuroimmune system using PET scans and measuring response to an inflammatory challenge.

Who is the study for?
This trial is for men and women aged 18-55 with PTSD, able to give informed consent. It's not for those with MRI contraindications like claustrophobia or metal implants, 'low binders' of the rs6971 polymorphism, pregnant/nursing women not using birth control, or individuals on immune-affecting meds or with certain medical conditions.Check my eligibility
What is being tested?
The study tests how a person's neuroimmune system reacts to an inflammatory challenge (LPS) by comparing PET scan results before and after LPS administration in people with PTSD versus controls. It also examines changes in cognitive function, subjective response, and physiological markers.See study design
What are the potential side effects?
Potential side effects from the LPS challenge may include flu-like symptoms such as fever, chills, headache, muscle pain; these are common reactions when the body's immune response is activated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with PTSD according to the latest standards.
Select...
I am between 18 and 55 years old.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Baseline TSPO Availability
Post-LPS TSPO Availability
Secondary outcome measures
Baseline Executive Function
Baseline Reward Responsiveness
Baseline Social Cognition
+13 more

Side effects data

From 2018 Phase 4 trial • 20 Patients • NCT02876601
81%
Headache
38%
Flu-like Symptoms
19%
Chills
13%
Nausea
13%
Arthralgia
6%
Precollapse
6%
Dizziness
6%
Vertigo
100%
80%
60%
40%
20%
0%
Study treatment Arm
Defibrotide Plus LPS
Placebo Plus LPS
Defibrotide Plus Placebo
Placebo/Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Post-LPS [11C]PBR28 PET ScanExperimental Treatment1 Intervention
Subjects will complete a second120-minute [11C]PBR28 PET scan 3-hours after LPS administration (1.0ng/kg; IV)
Group II: Baseline [11C]PBR28 PET ScanActive Control1 Intervention
Subjects will complete a 120-minute baseline [11C]PBR28 PET scan.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lipopolysaccharide
2017
Completed Phase 4
~260

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,737,588 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,689,069 Total Patients Enrolled
Kelly Cosgrove, PhDPrincipal Investigator - Yale University
Yale University
7 Previous Clinical Trials
356 Total Patients Enrolled

Media Library

Lipopolysaccharide Clinical Trial Eligibility Overview. Trial Name: NCT04236986 — Phase 1
Post-Traumatic Stress Disorder Research Study Groups: Post-LPS [11C]PBR28 PET Scan, Baseline [11C]PBR28 PET Scan
Post-Traumatic Stress Disorder Clinical Trial 2023: Lipopolysaccharide Highlights & Side Effects. Trial Name: NCT04236986 — Phase 1
Lipopolysaccharide 2023 Treatment Timeline for Medical Study. Trial Name: NCT04236986 — Phase 1
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04236986 — Phase 1

Frequently Asked Questions

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

Has Lipopolysaccharide been certified by the FDA?

"Lipopolysaccharide has not been tested extensively, therefore our team at Power assigned it a safety rating of 1. This is due to its Phase 1 status, meaning there is only minimal evidence with regards to efficacy and safety."

Answered by AI

Is enrollment still available for participants of this experiment?

"Evidently, this investigation is presently enrolling suitable participants. Initially posted on March 28th 2017 and revised most recently on May 17th 2022, the information available on clinicaltrials.gov endorses its current recruiting status."

Answered by AI

Is there an opportunity to participate in this medical research?

"The current trial is recruiting 80 individuals who have experienced moral injury and are aged 18-55. Notably, the participants must be male or female within this age range to qualify."

Answered by AI

What is the primary goal of this research endeavor?

"This 3-hour experiment, conducted after the administration of 1.0 ng/kg intravenously (IV), has been designed to measure Baseline TSPO Availability in subjects. Secondary objectives include Post-LPS Working Memory (% correct cards matched with previous one and two card presentations; arcsine(% correct) as higher scores reflect better working memory); Reward Responsiveness (quantified via computerized Probabilistic Reward Task); and Visual-motor Processing Speed (response latency detecting flipped over cards; log10(ms))."

Answered by AI

What is the sample size of participants in this research trial?

"Affirmative. The information accessible via clinicaltrials.gov implies that this medical experiment is recruiting volunteers, with the initial post being made on March 28th 2017 and last updated May 17th 2022. 80 individuals are required to be sourced from a single site."

Answered by AI

Are individuals aged 25 or more suitable for this scientific experiment?

"The acceptable range of ages to partake in this trial is 18-55 years old."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
What site did they apply to?
Yale University
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?

I've tried many drugs and nothing helps! I'm hoping this will!!!
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

What is it that I'm taking?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Imaging the Neuroimmune System in PTSD
Kelly Cosgrove 2017. "Imaging the Neuroimmune System in PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04236986.
All > Ptsd New York
~10 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top