Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630884
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Inflammatory Challenge and Fear
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Inflammatory Challenge and Fear Extinction A Model to Enhance Understanding of Posttraumatic Stress Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FEIV
Brief 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
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
Detailed Description:
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 vaccineplacebo 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None