Trial Outcomes & Findings for Imaging the Neuroimmune System in PTSD (NCT NCT04236986)
NCT ID: NCT04236986
Last Updated: 2024-12-09
Results Overview
Time-activity curves will be extracted from brain regions of interest and analyzed using multilinear analysis-1 (t\*=30) incorporating the metabolite-corrected arterial input function to yield \[11C\]PBR28 total volumes of distribution (VT) across brain regions.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Before LPS administration (baseline)
Results posted on
2024-12-09
Participant Flow
Participant milestones
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
3 subjects withdrew from HC population and 1 subject from PTSD population withdrew, prior to second PET scan and LPS injection.
Baseline characteristics by cohort
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
n=18 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
n=16 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=34 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=18 Participants
|
16 Participants
n=16 Participants
|
34 Participants
n=34 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=18 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=34 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=15 Participants • 3 subjects withdrew from HC population and 1 subject from PTSD population withdrew, prior to second PET scan and LPS injection.
|
6 Participants
n=15 Participants • 3 subjects withdrew from HC population and 1 subject from PTSD population withdrew, prior to second PET scan and LPS injection.
|
10 Participants
n=30 Participants • 3 subjects withdrew from HC population and 1 subject from PTSD population withdrew, prior to second PET scan and LPS injection.
|
|
Sex: Female, Male
Male
|
11 Participants
n=15 Participants • 3 subjects withdrew from HC population and 1 subject from PTSD population withdrew, prior to second PET scan and LPS injection.
|
9 Participants
n=15 Participants • 3 subjects withdrew from HC population and 1 subject from PTSD population withdrew, prior to second PET scan and LPS injection.
|
20 Participants
n=30 Participants • 3 subjects withdrew from HC population and 1 subject from PTSD population withdrew, prior to second PET scan and LPS injection.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
0 Participants
n=15 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
0 Participants
n=30 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
1 Participants
n=15 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
1 Participants
n=30 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
0 Participants
n=15 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
0 Participants
n=30 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=15 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
5 Participants
n=15 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
8 Participants
n=30 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
|
Race (NIH/OMB)
White
|
7 Participants
n=15 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
7 Participants
n=15 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
14 Participants
n=30 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
0 Participants
n=15 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
0 Participants
n=30 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=15 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
2 Participants
n=15 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
7 Participants
n=30 Participants • 3 healthy controls and 1 PTSD participant declined to continue/withdrew from study prior to second PET scan/LPS
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
16 participants
n=16 Participants
|
34 participants
n=34 Participants
|
PRIMARY outcome
Timeframe: Before LPS administration (baseline)Time-activity curves will be extracted from brain regions of interest and analyzed using multilinear analysis-1 (t\*=30) incorporating the metabolite-corrected arterial input function to yield \[11C\]PBR28 total volumes of distribution (VT) across brain regions.
Outcome measures
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
n=15 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
n=15 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
|---|---|---|
|
Baseline TSPO Availability
Amygdala
|
5.11 mL/cm3
Standard Deviation .85
|
4.75 mL/cm3
Standard Deviation 1.35
|
|
Baseline TSPO Availability
insula
|
5.07 mL/cm3
Standard Deviation .85
|
4.38 mL/cm3
Standard Deviation 1.1
|
|
Baseline TSPO Availability
vmPFC
|
5.33 mL/cm3
Standard Deviation .9
|
5.33 mL/cm3
Standard Deviation 1.16
|
|
Baseline TSPO Availability
hippocampus
|
4.89 mL/cm3
Standard Deviation .78
|
4.38 mL/cm3
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: 3-hours after LPS administration (1.0 ng/kg; IV)Time-activity curves will be extracted from brain regions of interest and analyzed using multilinear analysis-1 (t\*=30) incorporating the metabolite-corrected arterial input function to yield \[11C\]PBR28 total volumes of distribution (VT) across brain regions.
Outcome measures
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
n=15 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
n=15 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
|---|---|---|
|
Post-LPS TSPO Availability
Insula
|
7.14 mL/cm3
Standard Deviation 1.3
|
7.14 mL/cm3
Standard Deviation 2.1
|
|
Post-LPS TSPO Availability
vmPFC
|
7.73 mL/cm3
Standard Deviation 1.6
|
7.73 mL/cm3
Standard Deviation 1.8
|
|
Post-LPS TSPO Availability
Amygdala
|
7.2 mL/cm3
Standard Deviation 1.37
|
6.07 mL/cm3
Standard Deviation 2.12
|
|
Post-LPS TSPO Availability
Hippocampus
|
6.82 mL/cm3
Standard Deviation .87
|
5.66 mL/cm3
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Before LPS administrationVisual attention: response latency to identify card color (log10(ms); higher \~ worse attention).
Outcome measures
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
n=9 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
n=13 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
|---|---|---|
|
Baseline Visual Attention
|
2.624842444 log10(ms)
Interval 2.457448 to 2.951719
|
6.877150091 log10(ms)
Interval 2.312753 to 50.0
|
SECONDARY outcome
Timeframe: Approximately ~1-hour after LPS administrationVisual attention: response latency to identify card color (log10(ms); higher \~ worse attention).
Outcome measures
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
n=9 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
n=13 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
|---|---|---|
|
Post-LPS Visual Attention
|
2.54493925 log10(ms)
Interval 2.3893 to 2.713619
|
2.6069589 log10(ms)
Interval 2.333067 to 2.764084
|
SECONDARY outcome
Timeframe: Before LPS administrationVisual learning: % of correctly identified repeat cards (arcsine(% correct); higher values \~ better learning).
Outcome measures
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
n=9 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
n=13 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
|---|---|---|
|
Baseline Visual Learning
|
0.926197556 percentage of correct responses
Interval 0.0 to 1.306618
|
1.005693 percentage of correct responses
Interval 0.63029 to 1.336154
|
SECONDARY outcome
Timeframe: Approximately ~1-hour after LPS administrationVisual learning: % of correctly identified repeat cards (arcsine(% correct); higher values \~ better learning).
Outcome measures
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
n=9 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
n=13 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
|---|---|---|
|
Post-LPS Visual Learning
|
0.98078875 percentage of correct responses
Interval 0.82031 to 1.115727
|
0.9055107 percentage of correct responses
Interval 0.61548 to 1.209429
|
SECONDARY outcome
Timeframe: Before LPS administrationVerbal memory: summed number of correctly recalled items from a grocery list (over 3 trials). Each trial is not calculated individually. The reported value is the sum of all three trials.
Outcome measures
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
n=9 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
n=13 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
|---|---|---|
|
Baseline Verbal Memory
|
29.11111111 Number of correct responses
Interval 22.0 to 35.0
|
27.45454545 Number of correct responses
Interval 9.0 to 41.0
|
SECONDARY outcome
Timeframe: Approximately ~1-hour after LPS administrationVerbal memory: summed # of correctly recalled items from a grocery list (over 3 trials). Each trial is not calculated individually. The reported value is the sum of all three trials.
Outcome measures
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
n=9 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
n=13 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
|---|---|---|
|
Post-LPS Verbal Memory
|
26.75 Number of correct responses
Interval 18.0 to 31.0
|
25.7 Number of correct responses
Interval 18.0 to 33.0
|
SECONDARY outcome
Timeframe: Before LPS administrationExecutive function: summed number of errors navigating a 'hidden' maze (5 trials; higher \~ worse executive function).
Outcome measures
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
n=9 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
n=13 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
|---|---|---|
|
Baseline Executive Function
|
51.11111111 Number of errors
Interval 28.0 to 74.0
|
45.36363636 Number of errors
Interval 0.0 to 103.0
|
SECONDARY outcome
Timeframe: Approximately ~1-hour after LPS administrationExecutive function: summed number of errors navigating a 'hidden' maze (5 trials; higher \~ worse executive function).
Outcome measures
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
n=9 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
n=13 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
|---|---|---|
|
Post-LPS Executive Function
|
57.5 Number of errors
Interval 25.0 to 99.0
|
60.4 Number of errors
Interval 34.0 to 111.0
|
SECONDARY outcome
Timeframe: Before LPS administrationVisual-motor processing speed: response latency to detect a card flipped over (log10(ms); higher \~ worse processing speed).
Outcome measures
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
n=9 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
n=13 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
|---|---|---|
|
Baseline Visual-Motor Processing Speed
|
2.415812111 log10(ms)
Interval 0.0 to 2.878009
|
5.285026273 log10(ms)
Interval 2.54562 to 31.0
|
SECONDARY outcome
Timeframe: Approximately ~1-hour after LPS administrationVisual-motor processing speed: response latency to detect a card flipped over (log10(ms); higher \~ worse processing speed).
Outcome measures
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
n=9 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
n=13 Participants
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
|---|---|---|
|
Post-LPS Visual-Motor Processing Speed
|
2.74042025 log10(ms)
Interval 2.562187 to 2.859766
|
2.7598859 log10(ms)
Interval 2.54562 to 2.97832
|
SECONDARY outcome
Timeframe: Before LPS administrationPopulation: Data were not collected.
Social cognition: response latency to identify the mismatched facial expression based on its emotional content (ms; log10; higher \~ worse social cognition).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately ~1-hour after LPS administrationPopulation: Data were not collected.
Social cognition: response latency to identify the mismatched facial expression based on its emotional content (ms; log10; higher \~ worse social cognition).
Outcome measures
Outcome data not reported
Adverse Events
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PTSD Controls for HIC 2000020347
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Controls AKA Trauma Exposed Individuals Without PTSD For HIC 2000020347
n=18 participants at risk
We will recruit men and women aged 18-55 who have been exposed to trauma without PTSD into the study. Men and women, aged 18-55 years, any race, with a history of trauma exposure.
Trauma-exposed controls will have a CAPS-5 score of 0-22 (no/minimal to mild/subthreshold symptoms) Able to read and write English and to provide voluntary, written informed consent
|
PTSD Controls for HIC 2000020347
n=16 participants at risk
We will recruit men and women aged 18-55 who have been exposed to trauma with PTSD into the study. Men and women, aged 18-55 years, any race, with a history of PTSD, Subjects with posttraumatic stress disorder (PTSD) will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis) Able to read and write English and to provide voluntary, written informed consent
|
|---|---|---|
|
General disorders
Dull ache Loose Bowels
|
5.6%
1/18 • Number of events 1 • Subjects will be followed for 1 month after LPS injection and second PET scan.
this study will be monitored every 6 months by a Data Safety Monitoring Board (DSMB). Adequate surveillance and protections will be put in place to discover adverse events promptly and keep their effects to a minimum. There is an established DSMB at the Yale PET Center that meets every 6 months. Expected and Unexpected Adverse Events will be recorded according to PET Center and NIH guidelines
|
0.00%
0/16 • Subjects will be followed for 1 month after LPS injection and second PET scan.
this study will be monitored every 6 months by a Data Safety Monitoring Board (DSMB). Adequate surveillance and protections will be put in place to discover adverse events promptly and keep their effects to a minimum. There is an established DSMB at the Yale PET Center that meets every 6 months. Expected and Unexpected Adverse Events will be recorded according to PET Center and NIH guidelines
|
Additional Information
Dr. Kelly Cosgrove Principal Investigator
Yale University
Phone: 2037376969
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place