CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 34 enrolled
Drug / intervention
Lipopolysaccharidedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04236986
NCT04236986Phase 1Completed

Imaging the Neuroimmune System in PTSD With PET

Yale University·interventional·Posted Jan 22, 2020·Updated Dec 9, 2024

In Brief

A Phase 1 clinical trial evaluating Lipopolysaccharide for Post Traumatic Stress Disorder. Completed, enrolled 34 participants across 1 site.

Detailed Summary

In this study, individuals with and without post-traumatic stress disorder (PTSD) will undergo one positron emission tomography (PET) scan using the radiotracer \[11C\]PBR28, which binds to the 18kDa translocator protein (TSPO). A subset of individuals who complete the first PET \[11C\]PBR28 scan will be invited to complete an inflammatory challenge and second PET \[11C\]PBR28 scan. Approximately 3 hours prior to the second \[11C\]PBR28 PET scan, lipopolysaccharide (LPS; endotoxin) will be administered to evoke a robust neuroimmune response. Subjects will also undergo behavioral and cognitive testing. Vital signs, subjective response, and peripheral biomarker levels will be assayed periodically throughout the experimental session. Specific aims: 1) Determine if individuals with PTSD exhibit neuroimmune system disruption relative to well-matched comparators at baseline. 2) Determine if individuals with PTSD exhibit a disrupted neuroimmune response after a classical immune stimulus relative to well-matched comparators. 3) Determine if LPS differentially alters cognitive function, subjective response, or physiological markers in individuals with PTSD compared to well-matched comparators. Hypothesis: Individuals with PTSD will exhibit a suppressed neuroimmune system at baseline and an attenuated neuroimmune response following LPS challenge, relative to matched trauma controls.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 22, 2020
Enrollment StartMar 28, 2017
Primary CompletionMay 30, 2023
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 6.4 years ago

Interventions

Lipopolysaccharidedrug

LPS will be administered intravenously (1.0ng/kg; IV)