Adults 20 to 50, any sex, with Acute Inflammatory Response to Psychological Stress. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Cell-free Mitochondrial DNAPrimary· 5 minutes before task, and 5, 10, 20, 30, 45, 60, 75, 90 and 120 minutes after the task.
Serum levels of mitochondrial DNA assessed from blood samples
5 min pre-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
165.79
± 143.01
Control Session
405.56
± 1218.33
5 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
175.45
± 144.03
Control Session
164.45
± 133.03
10 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
414.74
± 1942.78
Control Session
296.62
± 629.78
20 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
153.37
± 144.03
Control Session
213.27
± 511.28
30 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
151.50
± 124.64
Control Session
163.41
± 147.62
45 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
171.53
± 178.85
Control Session
172.03
± 155.38
60 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
150.76
± 93.06
Control Session
215.58
± 437.87
75 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
183.87
± 216.89
Control Session
255.99
± 549.68
Interleukin-6Primary· 5 minutes before to 5, 10, 20, 30, 45, 60, 75, 90, 120 post-task periods
Plasma levels of interleukin-6
5 mins pre-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
1.52
± 1.29
Control Session
1.40
± 0.99
5 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
1.76
± 1.31
Control Session
1.58
± 0.94
10 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
1.61
± 1.24
Control Session
1.52
± 0.94
20 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
2.05
± 1.49
Control Session
1.78
± 1.01
30 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
2.01
± 1.44
Control Session
1.85
± 1.29
45 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
2.30
± 1.70
Control Session
2.15
± 1.32
60 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
2.50
± 1.76
Control Session
2.27
± 1.34
75 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
3.28
± 3.61
Control Session
3.06
± 2.84
Tumor Necrosis Factor-alphaPrimary· 5 minutes before to 5, 10, 20, 30, 45, 60, 75, 90, 120 post-task periods
Plasma levels of tumor necrosis factor-alpha
5 min pre-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
5.92
± 2.21
Control Session
6.10
± 2.21
5 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
6.62
± 1.90
Control Session
6.81
± 2.79
10 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
6.59
± 1.84
Control Session
6.28
± 1.92
20 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
6.70
± 1.72
Control Session
6.79
± 2.76
30 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
6.45
± 1.82
Control Session
6.35
± 1.89
45 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
6.61
± 1.76
Control Session
6.74
± 2.63
60 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
6.41
± 1.65
Control Session
6.52
± 2.51
75 min
Group
Value
95% CI
Socio-evaluative Speech Stress Session
6.58
± 1.68
Control Session
6.79
± 2.64
Heart RateSecondary· last 5 minutes of baseline, 5-min task-period, first two 5 minutes post-task.
Continuous measurement of heart rate was averaged across 4 periods: last 5 minutes of baseline, 5-min task-period, first two 5 minutes post-task.
Mean of 5 min pre-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
65.60
± 9.57
Control Session
66.76
± 9.53
mean of 5 min task period
Group
Value
95% CI
Socio-evaluative Speech Stress Session
79.27
± 14.44
Control Session
66.36
± 9.46
mean of min 1-5 post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
71.37
± 10.83
Control Session
67.43
± 9.20
mean of min 6-10 post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
66.00
± 9.46
Control Session
65.03
± 9.24
Systolic Blood PressureSecondary· 5 min pre-task and 5, 10, 20, 30, 45, 60, 75, 90, 120
Blood pressure was assessed twice on 10 occasions across the protocol. The two readings on each occasion were averaged.
5 min pre-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
111.18
± 9.47
Control Session
109.43
± 10.18
5 min post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
120.29
± 11.71
Control Session
110.70
± 9.46
10 min post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
120.02
± 12.58
Control Session
109.38
± 9.95
20 min post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
131.55
± 18.09
Control Session
109.23
± 10.43
30 min post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
135.63
± 16.62
Control Session
108.98
± 10.15
45 min post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
133.42
± 14.32
Control Session
109.14
± 10.12
60 min post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
125.43
± 13.54
Control Session
109.46
± 10.59
75 min post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
120.61
± 12.45
Control Session
109.59
± 12.07
Diastolic Blood PressureSecondary· 5 min pre-task and 5, 10, 20, 30, 45, 60, 75, 90, 120 post task onset
Diastolic blood pressure was assessed two times on 10 occasions across the protocol. On each occasion, the two measures were averaged.
5 min pre-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
67.69
± 9.47
Control Session
65.74
± 10.18
5 min post-task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
72.00
± 11.71
Control Session
66.02
± 9.46
10 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
72.65
± 12.58
Control Session
65.17
± 9.95
20 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
79.58
± 18.09
Control Session
65.27
± 10.43
30 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
81.57
± 16.62
Control Session
66.42
± 10.15
45 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
79.03
± 14.32
Control Session
65.71
± 10.12
60 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
71.80
± 13.54
Control Session
66.17
± 10.59
75 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
68.02
± 12.45
Control Session
65.86
± 12.07
CortisolSecondary· 5 minutes before to 10, 20, 30, 45, 60 minutes post-task periods
Circulating levels of cortisol assessed by ELISA
5 min pre-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
1.50
± 0.72
Control Session
1.48
± 0.76
10 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
1.46
± 0.76
Control Session
1.30
± 0.62
20 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
1.57
± 0.86
Control Session
1.30
± 0.63
30 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
1.49
± 0.64
Control Session
1.24
± 0.64
45 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
1.43
± 0.62
Control Session
1.24
± 0.66
60 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
1.35
± 0.72
Control Session
1.18
± 0.60
EpinephrineSecondary· 5 minutes before to 5, 10, 20, 30, & 60 minutes post-task periods
Levels of epinephrine in plasma
5 min pre-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
50.56
± 20.09
Control Session
48.62
± 21.67
5 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
54.01
± 23.87
Control Session
47.46
± 21.19
10 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
49.81
± 18.69
Control Session
52.48
± 28.98
20 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
47.95
± 18.12
Control Session
45.16
± 17.38
30 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
47.08
± 16.63
Control Session
44.26
± 18.35
60 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
48.34
± 17.78
Control Session
41.64
± 16.43
NorepinephrineSecondary· 5 minutes before to 5, 10, 20, 30, & 60 minutes post-task periods
Levels of norepinephrine in plasma
5 min pre-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
522.86
± 228.82
Control Session
480.48
± 175.92
5 min post-task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
540.39
± 178.62
Control Session
485.44
± 157.60
10 min post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
526.93
± 187.47
Control Session
484.38
± 151.81
20 min post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
494.17
± 173.34
Control Session
470.70
± 172.50
30 min post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
477.84
± 191.16
Control Session
476.14
± 155.51
60 min post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
472.74
± 156.83
Control Session
461.97
± 160.05
Heart Rate VariabilitySecondary· Pre-task, task, and 1-5 and 6-10 minutes post task
Interbeat intervals of heart rate assessed by 3-lead EKG. Measures were taken continuously from 5 minutes before the task to 10 minutes after the task. Rsults were then averaged across 4 periods: 5 minutes prior to the task, the 5-minute task period, and 5-, and 10-minutes post task
Mean across 5 min pre-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
6.50
± 1.05
Control Session
6.58
± 0.81
Mean across 5 min task period
Group
Value
95% CI
Socio-evaluative Speech Stress Session
5.94
± 0.96
Control Session
6.50
± 0.92
Mean across minutes 1-5 post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
6.18
± 0.97
Control Session
6.37
± 0.85
Mean across 6-10 minutes post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
6.30
± 0.93
Control Session
6.43
± 0.91
FatigueSecondary· 2 minutes before and 2, 60, and 120 minutes post-task periods
Momentary assessment of fatigue, measured as score on the fatigue subscale on the brief Profile of Mood States questionnaire. Scores range from 0 - 20, with higher scores reflecting more fatigue.
Pre-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
4.76
± 4.02
Control Session
5.47
± 3.72
post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
2.59
± 2.75
Control Session
5.36
± 3.86
60 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
5.79
± 4.15
Control Session
6.48
± 4.62
120 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
5.50
± 4.50
Control Session
5.41
± 4.36
AngerSecondary· 2 minutes before and 2-, 60-, and 120-minutes post-task periods
Momentary assessment of anger, measured as score on the anger subscale on the brief Profile of Mood States questionnaire in response to the task periods. Scores range from 0 - 12, with higher scores reflecting more anger.
Pre-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
0.30
± 1.03
Control Session
0.08
± 0.42
2 min post-task
Group
Value
95% CI
Socio-evaluative Speech Stress Session
0.70
± 1.57
Control Session
0.20
± 1.05
60 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
0.49
± 1.39
Control Session
0.16
± 0.72
120 min post task onset
Group
Value
95% CI
Socio-evaluative Speech Stress Session
0.45
± 1.51
Control Session
0.14
± 0.59
Sponsor's own description
The investigators plan to conduct a crossover experimental trial examining physiological responses to a socio-evaluative speech task under laboratory conditions. Participants will attend two laboratory sessions. At one session participants will take part in a brief laboratory stress task and at the other participants will rest for the same period. Measures of cardiovascular response will be assessed at both sessions. In addition, blood will be drawn at multiple time points across a 125 minute period to assess changes in circulating levels of cortisol, catecholamines, markers of inflammation and cell free mitochondrial DNA in response to the task. The investigators expect that the stress task will induce a specific increase in ccf-mtDNA, which will statistically mediate subsequent peak circulating Interleukin-6 and Tumor Necrosis Factor-α levels. In secondary analyses, the investigators will examine whether stress-induced increases in circulating cortisol, epinephrine, and norepinephrine levels correlate with increases in ccf-mtDNA. These studies will establish the kinetics and magnitude of psychological stress-induced ccf-mtDNA release, the association with early stress mediators, and whether ccf-mtDNA mediates the inflammatory response to acute stress in humans.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pittsburgh
Last refreshed: 1 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04078035.