Inflammatory Challenge and Fear
a study on Post-Traumatic Stress Disorder Stress
Summary
- Eligibility
- for people ages 25-45 (full criteria)
- Healthy Volunteers
- healthy people welcome
- Location
- at San Francisco, California
- Dates
- study startedcompletion around
- Principal Investigator
- by Aoife O'Donovan, PhD
Description
Summary
The goal of this study is to learn if short-term changes in the immune system alter how we process information and experience fear. The main questions it aims to answer are:
Do people who receive typhoid vaccine respond differently than those who receive a placebo saline vaccine? Do people who receive typhoid vaccine experience changes in how they think and feel?
Participants will:
Attend four appointments at the San Francisco VA Health Care System;
Receive typhoid vaccine or placebo at one of the visits;
Have their physiological responding measured while listening to sounds;
Complete questionnaires and psychological tests.
Official Title
Inflammatory Challenge and Fear Extinction: A Model to Enhance Understanding of Posttraumatic Stress Disorder
Details
Posttraumatic stress disorder (PTSD) is a chronic disorder affecting more than 8% of the general population and two-three times as many women as men. Deficits in fear responding play a critical role in PTSD. Interventions that target fear responding are first-line treatments for PTSD, but they are only partially effective. To develop new and enhanced interventions, we need a better understanding of the factors that influence fear responding in PTSD in both females and males. One such factor is inflammation, which is elevated in response to acute psychological stress and in PTSD. Preclinical models indicate that elevated inflammation in general, and elevated levels of the pro-inflammatory cytokine interleukin-6 (IL-6) in particular, can impair fear responses. People with PTSD and women may be more sensitive to the effects of inflammatory activity on fear responses. Our long-term goal is to uncover the mechanistic role that inflammation plays in PTSD in order to identify effective primary and adjunctive anti-inflammatory interventions. Our objective in this proposal is to determine the effects of acute inflammatory challenge on fear responding in trauma-exposed women and men with and without PTSD. Our central hypothesis is that acute inflammatory challenge will alter fear responding, with particularly strong effects in people with chronic PTSD and women. Our aims are to: 1) determine the effects of acute inflammatory challenge on fear responding in individuals with and without PTSD; 2) examine if increases in inflammatory activity mediate associations between acute inflammatory challenge and fear responses; and 3) elucidate sex differences in the effects of acute inflammatory challenge on fear responses. In our proposed study, we will use polysaccharide typhoid vaccine, which our preliminary data support as a robust acute inflammatory challenge, and a fear learning paradigm that we have used in >200 people with PTSD. Participants will first undergo physiological testing of fear responses. Then, three days later, they will receive either vaccine or placebo and undergo more tests, including physiological tests. One week later, we will test physiological responses again. Inflammatory markers will be measured at baseline, twice on the the vaccine/placebo day, and once at the one-week follow-up visit. This proposal is significant and innovative because it would be the first study to examine the effects of acute inflammatory activity on fear responses in trauma-exposed individuals with and without PTSD, and it has potential to elucidate biological mechanisms of impaired fear responses, uncover sex differences, and point us in the direction of novel interventions to treat PTSD.
Keywords
Posttraumatic Stress Disorder (PTSD), PTSD, posttraumatic stress, inflammation, fear, Traumatic Stress Disorders, Post-Traumatic Stress Disorders, Typhoid VI Polysaccharide Vaccine Injectable Solution, Polysaccharide typhoid vaccine
Eligibility
You can join if…
Open to people ages 25-45
All Subjects:
- Aged 25-45 years old
- Trauma Exposed
- Current PTSD/No history of PTSD
You CAN'T join if...
- Contraindications to typhoid vaccine
- Conditions associated with inflammation
- Pregnancy or plans to become pregnant in next three months
- Lack of skin conductance response to breathing and arithmetic tasks at screening visit
Location
- San Francisco VA Health Care System
accepting new patients
San Francisco California 94121 United States
Lead Scientist at UCSF
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- University of California, San Francisco
- Links
- Related Info
- ID
- NCT06630884
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- Expecting 288 study participants
- Last Updated
Frequently Asked Questions
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT06630884.