Trial Outcomes & Findings for Key Dimensions of PTSD and ED (NCT NCT03778307)
NCT ID: NCT03778307
Last Updated: 2026-07-24
Results Overview
FMD is the percent difference in diameter of the brachial artery, before and after occlusion. Impaired endothelial function occurs when blood vessels are unable to dilate fully in response to nitric oxide synthesis and release, which is manifested as impaired endothelium-dependent vasodilation (i.e., lower FMD). Lower FMD has been associated with the degree of coronary atherosclerosis and predicts CVD events.
COMPLETED
168 participants
Baseline
2026-07-24
Participant Flow
Participant milestones
| Measure |
Trauma Exposed With PTSD
Individuals with a history of trauma exposure and a current diagnosis of PTSD
|
Trauma Exposed Without PTSD
Individuals with a history of trauma exposure who do not have current PTSD
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
82
|
|
Overall Study
COMPLETED
|
86
|
82
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Key Dimensions of PTSD and ED
Baseline characteristics by cohort
| Measure |
Trauma Exposed Without PTSD
n=82 Participants
Individuals with a history of trauma exposure who do not have current PTSD
|
Trauma Exposed With PTSD
n=86 Participants
Individuals with a history of trauma exposure and a current diagnosis of PTSD
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.63 Years
STANDARD_DEVIATION 15.62 • n=9 Participants
|
34.25 Years
STANDARD_DEVIATION 11.41 • n=27 Participants
|
38.34 Years
STANDARD_DEVIATION 14.22 • n=267 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=9 Participants
|
49 Participants
n=27 Participants
|
94 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=9 Participants
|
37 Participants
n=27 Participants
|
74 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=9 Participants
|
18 Participants
n=27 Participants
|
36 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=9 Participants
|
35 Participants
n=27 Participants
|
72 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
15 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=9 Participants
|
28 Participants
n=27 Participants
|
53 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=9 Participants
|
58 Participants
n=27 Participants
|
115 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Some participants had unusable FMD data (e.g., due to poor image quality, movement during the protocol).
FMD is the percent difference in diameter of the brachial artery, before and after occlusion. Impaired endothelial function occurs when blood vessels are unable to dilate fully in response to nitric oxide synthesis and release, which is manifested as impaired endothelium-dependent vasodilation (i.e., lower FMD). Lower FMD has been associated with the degree of coronary atherosclerosis and predicts CVD events.
Outcome measures
| Measure |
Trauma Exposed Without PTSD
n=74 Participants
Individuals with a history of trauma exposure who do not have current PTSD
|
Trauma Exposed With PTSD
n=76 Participants
Individuals with a history of trauma exposure and a current diagnosis of PTSD
|
|---|---|---|
|
Flow-mediated Dilation of the Brachial Artery (FMD) %
|
5.52 % change in brachial artery diameter
Standard Deviation 2.16
|
6.18 % change in brachial artery diameter
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: BaselinePopulation: Some participants were unable to provide blood samples for quantifying EMPs or had unusable data for flow cytometry analyses.
EMPs expressing CD62E (i.e., endothelial cell activation) and CD31 (i.e., endothelial cell apoptosis) will be measured. Assessments of circulating EMPs will be measured using flow cytometry, and total flow cytometry counts will be converted to the number of EMPs per uL of blood. Higher concentrations of EMPs expressing CD62E and CD31 indicate greater endothelial dysfunction.
Outcome measures
| Measure |
Trauma Exposed Without PTSD
n=76 Participants
Individuals with a history of trauma exposure who do not have current PTSD
|
Trauma Exposed With PTSD
n=84 Participants
Individuals with a history of trauma exposure and a current diagnosis of PTSD
|
|---|---|---|
|
Circulating Endothelial Cell-derived Microparticles (EMPs) Expressing CD62E
|
789.33 Number of EMPs per uL of blood
Standard Deviation 406.96
|
880.23 Number of EMPs per uL of blood
Standard Deviation 713.42
|
SECONDARY outcome
Timeframe: BaselinePopulation: Some participants were unable to provide blood samples for quantifying EMPs or had unusable data for flow cytometry analyses.
EMPs expressing CD62E (i.e., endothelial cell activation) and CD31 (i.e., endothelial cell apoptosis) will be measured. Assessments of circulating EMPs will be measured using flow cytometry, and total flow cytometry counts will be converted to the number of EMPs per uL of blood. Higher concentrations of EMPs expressing CD62E and CD31 indicate greater endothelial dysfunction.
Outcome measures
| Measure |
Trauma Exposed Without PTSD
n=76 Participants
Individuals with a history of trauma exposure who do not have current PTSD
|
Trauma Exposed With PTSD
n=84 Participants
Individuals with a history of trauma exposure and a current diagnosis of PTSD
|
|---|---|---|
|
Circulating Endothelial Cell-derived Microparticles (EMPs) Expressing CD31
|
2396.24 Number of EMPs per uL of blood
Standard Deviation 1942.66
|
2275.15 Number of EMPs per uL of blood
Standard Deviation 2315.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Some individuals did not have usable fear-potentiated startle data.
Fear-potentiated startle (FPS) to the danger cue (CS+) during early extinction as part of a fear acquisition and extinction paradigm; this measure reflects expression of conditioned fear during early extinction. FPS is measured through corrugator and orbicularis electromyography (EMG). Startle magnitude is assessed as the peak amplitude (in microVolts) of EMG contraction 20-200ms following the startle probe. A difference score for FPS is calculated by subtracting the startle magnitude to the noise alone probe from the startle magnitude to the CS to account for individual differences in startle magnitude and habituation. Higher values of this FPS difference score indicate greater fear load (i.e., greater overexpression of conditioned fear to a now safe signal during early extinction), which has been associated with PTSD.
Outcome measures
| Measure |
Trauma Exposed Without PTSD
n=81 Participants
Individuals with a history of trauma exposure who do not have current PTSD
|
Trauma Exposed With PTSD
n=81 Participants
Individuals with a history of trauma exposure and a current diagnosis of PTSD
|
|---|---|---|
|
Fear Load Based on Fear-potentiated Startle During Early Extinction
|
32.24 FPS difference score
Standard Deviation 36.81
|
36.27 FPS difference score
Standard Deviation 46.84
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineAveraged total dwell time of the happy faces Area of Interest (AOI) across 60 face matrices; reflects continuous gaze allocation to happy stimuli
Outcome measures
| Measure |
Trauma Exposed Without PTSD
n=82 Participants
Individuals with a history of trauma exposure who do not have current PTSD
|
Trauma Exposed With PTSD
n=86 Participants
Individuals with a history of trauma exposure and a current diagnosis of PTSD
|
|---|---|---|
|
Averaged Total Dwell Time for Happy Faces
|
2202.44 Dwell time in milliseconds
Standard Deviation 329.30
|
2223.98 Dwell time in milliseconds
Standard Deviation 355.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineAveraged total dwell time of the sad faces Area of Interest (AOI) across 60 face matrices; reflects continuous gaze allocation to sad stimuli
Outcome measures
| Measure |
Trauma Exposed Without PTSD
n=82 Participants
Individuals with a history of trauma exposure who do not have current PTSD
|
Trauma Exposed With PTSD
n=86 Participants
Individuals with a history of trauma exposure and a current diagnosis of PTSD
|
|---|---|---|
|
Averaged Total Dwell Time for Sad Faces
|
2038.77 Dwell time in milliseconds
Standard Deviation 266.62
|
2065.38 Dwell time in milliseconds
Standard Deviation 335.13
|
Adverse Events
Trauma Exposed Without PTSD
Trauma Exposed With PTSD
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place