Trial Outcomes & Findings for Cortisol Suppression and Startle Responses in Posttraumatic Stress Disorder (PTSD) (NCT NCT01477762)
NCT ID: NCT01477762
Last Updated: 2017-04-18
Results Overview
The study measured the acoustic startle response magnitude to a sudden noise using electromyography of the eyeblink muscle. This response magnitude was used as the individual's baseline to compare to the startle magnitude to the danger signal to see if fear conditioning had occurred.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
165 participants
Primary outcome timeframe
10 hours after drug administration
Results posted on
2017-04-18
Participant Flow
Participants were recruited from Grady Memorial Hospital in Atlanta, Georgia.
Of the 165 participants enrolled, 91 met the inclusion criteria and began the study. Sixty three participants completed all study visits for which data were analyzed.
Participant milestones
| Measure |
PTSD Negative: Placebo First, Then Dexamethasone
Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
|
PTSD Negative: Dexamethasone First, Then Placebo
Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
|
PTSD Positive: Placebo First, Then Dexamethosone
Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
|
PTSD Positive: Dexamethasone First, Then Placebo
Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
33
|
20
|
13
|
|
Overall Study
COMPLETED
|
16
|
20
|
16
|
11
|
|
Overall Study
NOT COMPLETED
|
9
|
13
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cortisol Suppression and Startle Responses in Posttraumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
PTSD Negative: Placebo First, Then Dexamethasone
n=16 Participants
Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
|
PTSD Negative: Dexamethasone First, Then Placebo
n=20 Participants
Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
|
PTSD Positive: Placebo First, Then Dexamethosone
n=16 Participants
Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
|
PTSD Positive: Dexamethasone First, Then Placebo
n=11 Participants
Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.13 years
STANDARD_DEVIATION 3.13 • n=5 Participants
|
43.10 years
STANDARD_DEVIATION 2.80 • n=7 Participants
|
43.067 years
STANDARD_DEVIATION 3.237 • n=5 Participants
|
45.46 years
STANDARD_DEVIATION 3.78 • n=4 Participants
|
42.4 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
14 participants
n=5 Participants
|
10 participants
n=4 Participants
|
58 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
20 participants
n=7 Participants
|
16 participants
n=5 Participants
|
11 participants
n=4 Participants
|
63 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 10 hours after drug administrationThe study measured the acoustic startle response magnitude to a sudden noise using electromyography of the eyeblink muscle. This response magnitude was used as the individual's baseline to compare to the startle magnitude to the danger signal to see if fear conditioning had occurred.
Outcome measures
| Measure |
PTSD Negative: Placebo First, Then Dexamethasone
n=16 Participants
Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
|
PTSD Negative: Dexamethasone First, Then Placebo
n=20 Participants
Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
|
PTSD Positive: Placebo First, Then Dexamethosone
n=16 Participants
Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
|
PTSD Positive: Dexamethasone First, Then Placebo
n=11 Participants
Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
|
|---|---|---|---|---|
|
Mean Baseline Startle Magnitude During Fear Conditioning
Placebo
|
48.401 microvolts
Standard Error 30.001
|
56.595 microvolts
Standard Error 26.420
|
115.778 microvolts
Standard Error 29.538
|
57.684 microvolts
Standard Error 35.624
|
|
Mean Baseline Startle Magnitude During Fear Conditioning
Dexamethasone
|
42.842 microvolts
Standard Error 16.371
|
72.072 microvolts
Standard Error 12.141
|
45.000 microvolts
Standard Error 14.511
|
59.534 microvolts
Standard Error 16.371
|
PRIMARY outcome
Timeframe: 10 hours after drug administrationThe acoustic startle response magnitude was measured using electromyography recordings of the eyeblink muscle when a sudden tone was delivered through headphones in the presence of a stimulus that was paired with an aversive outcome (i.e. the danger signal). If an individual showed successful fear learning, then startle to the danger signal would be greater than baseline startle.
Outcome measures
| Measure |
PTSD Negative: Placebo First, Then Dexamethasone
n=16 Participants
Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
|
PTSD Negative: Dexamethasone First, Then Placebo
n=20 Participants
Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
|
PTSD Positive: Placebo First, Then Dexamethosone
n=16 Participants
Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
|
PTSD Positive: Dexamethasone First, Then Placebo
n=11 Participants
Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
|
|---|---|---|---|---|
|
Mean Startle Magnitude to Danger Signal During Fear Conditioning
Placebo
|
98.734 microvolts
Standard Error 31.926
|
94.912 microvolts
Standard Error 28.556
|
143.360 microvolts
Standard Error 31.926
|
76.294 microvolts
Standard Error 38.505
|
|
Mean Startle Magnitude to Danger Signal During Fear Conditioning
Dexamethasone
|
80.825 microvolts
Standard Error 24.892
|
113.208 microvolts
Standard Error 18.461
|
84.133 microvolts
Standard Error 22.065
|
88.079 microvolts
Standard Error 24.892
|
PRIMARY outcome
Timeframe: 10 hours after drug administrationFear-potentiated startle was measured as a difference score between the startle to danger signal and the baseline. This difference score reflects the degree of fear response at the beginning of extinction.
Outcome measures
| Measure |
PTSD Negative: Placebo First, Then Dexamethasone
n=16 Participants
Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
|
PTSD Negative: Dexamethasone First, Then Placebo
n=20 Participants
Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
|
PTSD Positive: Placebo First, Then Dexamethosone
n=16 Participants
Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
|
PTSD Positive: Dexamethasone First, Then Placebo
n=11 Participants
Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
|
|---|---|---|---|---|
|
Mean Fear-potentiated Startle to Danger Signal During Early Extinction
Placebo
|
29.211 microvolts
Standard Deviation 10.046
|
17.328 microvolts
Standard Deviation 9.170
|
33.404 microvolts
Standard Deviation 10.046
|
37.099 microvolts
Standard Deviation 11.731
|
|
Mean Fear-potentiated Startle to Danger Signal During Early Extinction
Dexamethasone
|
18.715 microvolts
Standard Deviation 8.900
|
25.119 microvolts
Standard Deviation 7.708
|
42.511 microvolts
Standard Deviation 8.900
|
21.250 microvolts
Standard Deviation 9.951
|
PRIMARY outcome
Timeframe: 10 hours after drug administrationThis measures the level of fear-potentiated startle (the difference between startle magnitude to the danger signal and baseline startle magnitude) at the end of extinction. Because the danger signal is no longer paired with the aversive stimulus like it was during the conditioning phase, the fear response should decrease from early to late extinction in individuals who show intact extinction learning.
Outcome measures
| Measure |
PTSD Negative: Placebo First, Then Dexamethasone
n=16 Participants
Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
|
PTSD Negative: Dexamethasone First, Then Placebo
n=20 Participants
Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
|
PTSD Positive: Placebo First, Then Dexamethosone
n=16 Participants
Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
|
PTSD Positive: Dexamethasone First, Then Placebo
n=11 Participants
Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.
Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.
Placebo: One placebo tablet was taken ten hours prior to completing study assessments.
|
|---|---|---|---|---|
|
Mean Fear-potentiated Startle to Danger Signal During Late Extinction
Placebo
|
1.620 microvolts
Standard Error 17.839
|
-7.824 microvolts
Standard Error 16.285
|
30.858 microvolts
Standard Error 17.839
|
13.369 microvolts
Standard Error 20.832
|
|
Mean Fear-potentiated Startle to Danger Signal During Late Extinction
Dexamethasone
|
-1.867 microvolts
Standard Error 6.114
|
-10.440 microvolts
Standard Error 5.295
|
2.253 microvolts
Standard Error 6.114
|
0.897 microvolts
Standard Error 6.836
|
Adverse Events
PTSD Negative: Placebo First, Then Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PTSD Negative: Dexamethasone First, Then Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PTSD Positive: Placebo First, Then Dexamethosone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PTSD Positive: Dexamethasone First, Then Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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