Trial Outcomes & Findings for Stress and the Nervous System (NCT NCT02339506)
NCT ID: NCT02339506
Last Updated: 2025-12-03
Results Overview
Cardiovagal baroreflex sensitivity will be measured with the Modified Oxford Technique before, during, and after drug infusions, to evaluate the effects of cosyntropin infusions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Baseline, 4-hours after infusion, 24-hours after infusion
Results posted on
2025-12-03
Participant Flow
Participant milestones
| Measure |
Placebo (Period 1)/Washout (Period 2)/Cosyntropin (Period 3)
Period 1: Subjects will receive a placebo infusion for two sessions of 2.5 hours each on day 2 of their first three day admission to our research center.
Period 2: Washout for one month Period 3: Subjects will receive cosyntropin infusion at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of their second three day admission to our research center.
|
Cosyntropin (Period 1)/Washout (Period 2)/ Placebo (Period 3)
Period 1: Subjects will receive a cosyntropin infusion at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of their first three day admission to our research center.
Period 2: Washout for one month Period 3: Subjects will receive a placebo infusion for two sessions of 2.5 hours each on day 2 of their second three day admission to our research center.
|
|---|---|---|
|
Period 1 (Placebo or Cosyntropin)
STARTED
|
12
|
11
|
|
Period 1 (Placebo or Cosyntropin)
COMPLETED
|
12
|
10
|
|
Period 1 (Placebo or Cosyntropin)
NOT COMPLETED
|
0
|
1
|
|
Washout (Period 2)
STARTED
|
12
|
10
|
|
Washout (Period 2)
COMPLETED
|
10
|
10
|
|
Washout (Period 2)
NOT COMPLETED
|
2
|
0
|
|
Period 3 (Placebo or Cosyntropin)
STARTED
|
10
|
10
|
|
Period 3 (Placebo or Cosyntropin)
COMPLETED
|
10
|
10
|
|
Period 3 (Placebo or Cosyntropin)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo (Period 1)/Washout (Period 2)/Cosyntropin (Period 3)
Period 1: Subjects will receive a placebo infusion for two sessions of 2.5 hours each on day 2 of their first three day admission to our research center.
Period 2: Washout for one month Period 3: Subjects will receive cosyntropin infusion at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of their second three day admission to our research center.
|
Cosyntropin (Period 1)/Washout (Period 2)/ Placebo (Period 3)
Period 1: Subjects will receive a cosyntropin infusion at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of their first three day admission to our research center.
Period 2: Washout for one month Period 3: Subjects will receive a placebo infusion for two sessions of 2.5 hours each on day 2 of their second three day admission to our research center.
|
|---|---|---|
|
Period 1 (Placebo or Cosyntropin)
Withdrawal by Subject
|
0
|
1
|
|
Washout (Period 2)
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Stress and the Nervous System
Baseline characteristics by cohort
| Measure |
Healthy Control
n=23 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4-hours after infusion, 24-hours after infusionCardiovagal baroreflex sensitivity will be measured with the Modified Oxford Technique before, during, and after drug infusions, to evaluate the effects of cosyntropin infusions.
Outcome measures
| Measure |
Cosyntropin
n=20 Participants
Subjects will receive cosyntropin infusion at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.
Cosyntropin: Subjects will receive cosyntropin at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.
|
Normal Saline (Placebo)
n=20 Participants
Subjects will receive normal saline infusion for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.
Placebo: Subjects will receive placebo (normal saline infusion) for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.
|
|---|---|---|
|
Cardiovagal Baroreflex Sensitivity (Modified Oxford Technique)
4-hours after infusion
|
14.42 ms/mmHg
Standard Deviation 5.89
|
17.27 ms/mmHg
Standard Deviation 6.79
|
|
Cardiovagal Baroreflex Sensitivity (Modified Oxford Technique)
24-hours after infusion
|
14.76 ms/mmHg
Standard Deviation 5.83
|
18.90 ms/mmHg
Standard Deviation 8.40
|
|
Cardiovagal Baroreflex Sensitivity (Modified Oxford Technique)
Baseline
|
17.75 ms/mmHg
Standard Deviation 5.47
|
16.90 ms/mmHg
Standard Deviation 8.63
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 day after ACTHAlterations in pain sensing will be evaluated pre and post with quantitative sensory testing using a thermal pain testing device, to evaluate the delayed effect of cosyntropin infusions.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 day after ACTHHippocampal memory will be evaluated pre and post with a paired associative learning task. Face Name Associative Memory Exam (FNAME) composite score on a scale from 0-36, with 36 being the best possible score.
Outcome measures
| Measure |
Cosyntropin
n=20 Participants
Subjects will receive cosyntropin infusion at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.
Cosyntropin: Subjects will receive cosyntropin at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.
|
Normal Saline (Placebo)
n=20 Participants
Subjects will receive normal saline infusion for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.
Placebo: Subjects will receive placebo (normal saline infusion) for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.
|
|---|---|---|
|
Hippocampal Memory (Paired Associative Learning Task)
Baseline
|
27.8 score on a scale
Standard Deviation 3.7
|
29.3 score on a scale
Standard Deviation 2.8
|
|
Hippocampal Memory (Paired Associative Learning Task)
1 day after infusion
|
25.6 score on a scale
Standard Deviation 4.1
|
25.9 score on a scale
Standard Deviation 4.1
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cosyntropin
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 |
Placebo
n=22 participants at risk
|
Cosyntropin
n=21 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
vomiting
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Subject had less blood drawn
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place