Trial Outcomes & Findings for Veteran Stress and Learning Study (NCT NCT00674570)
NCT ID: NCT00674570
Last Updated: 2019-05-30
Results Overview
Psychophysiology measurements occurred on day 7 for fear conditioning, day 9 for fear extinction, and day 11 for extinction retention. The primary outcome measures are presented for the first and last conditioned stimulus (CS) trials during fear conditioning and extinction and for the first 2 trials during retention. Conditioned Responses (CR): An SCR score was obtained for each CS by subtracting the mean skin conductance level (SCL) in microsiemens (µS) for the 2-s interval immediately preceding CS onset from the max SC level in µS during the 8-s CS presentation. Unconditioned Response (UCR): An SCR score for the UCR was obtained by subtracting the mean SCL in µS within 6-8 s following CS offset from the max increase in SC level during the .5-6.5 time interval following the CS offset, corresponding to the onset of the .5s US. SC responses were range corrected using each participant's maximum response to the UCS or CS during acquisition trials of the fear conditioning phase.
COMPLETED
PHASE4
111 participants
15 minute measurement intervals on Study Days 7, 9, and 16
2019-05-30
Participant Flow
Participation involved 4 study visits, with randomization to intervention arm and drug administration occurring on visit 3. The discrepancy between 111 participants who were initially enrolled and 106 at randomization resulted from 5 participants who dropped out between screening and visit 3, when they were to have been assigned into a group.
Participant milestones
| Measure |
Arm 1: Hydrocortisone
Hydrocortisone
Hydrocortisone: 25 mg/oral one hour prior to extinction task
|
Arm 2: D-Cycloserine
D-Cycloserine
D-Cycloserine: 50 mg/oral one hour prior to extinction task
|
Arm 3: Placebo
Placebo
Placebo: One hour prior to extinction task
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
34
|
35
|
|
Overall Study
COMPLETED
|
37
|
32
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: Hydrocortisone
Hydrocortisone
Hydrocortisone: 25 mg/oral one hour prior to extinction task
|
Arm 2: D-Cycloserine
D-Cycloserine
D-Cycloserine: 50 mg/oral one hour prior to extinction task
|
Arm 3: Placebo
Placebo
Placebo: One hour prior to extinction task
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
Baseline Characteristics
Veteran Stress and Learning Study
Baseline characteristics by cohort
| Measure |
Arm 1: Hydrocortisone
n=37 Participants
Hydrocortisone
Hydrocortisone: 25 mg/oral one hour prior to extinction task
|
Arm 2: D-Cycloserine
n=34 Participants
D-Cycloserine
D-Cycloserine: 50 mg/oral one hour prior to extinction task
|
Arm 3: Placebo
n=35 Participants
Placebo
Placebo: One hour prior to extinction task
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
41.1 years
STANDARD_DEVIATION 13.7 • n=107 Participants
|
40.0 years
STANDARD_DEVIATION 11.8 • n=206 Participants
|
38.6 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
88 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
68 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
106 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 15 minute measurement intervals on Study Days 7, 9, and 16Psychophysiology measurements occurred on day 7 for fear conditioning, day 9 for fear extinction, and day 11 for extinction retention. The primary outcome measures are presented for the first and last conditioned stimulus (CS) trials during fear conditioning and extinction and for the first 2 trials during retention. Conditioned Responses (CR): An SCR score was obtained for each CS by subtracting the mean skin conductance level (SCL) in microsiemens (µS) for the 2-s interval immediately preceding CS onset from the max SC level in µS during the 8-s CS presentation. Unconditioned Response (UCR): An SCR score for the UCR was obtained by subtracting the mean SCL in µS within 6-8 s following CS offset from the max increase in SC level during the .5-6.5 time interval following the CS offset, corresponding to the onset of the .5s US. SC responses were range corrected using each participant's maximum response to the UCS or CS during acquisition trials of the fear conditioning phase.
Outcome measures
| Measure |
Arm 1: Hydrocortisone
n=37 Participants
Hydrocortisone
Hydrocortisone: 25 mg/oral one hour prior to extinction task
|
Arm 2: D-Cycloserine
n=32 Participants
D-Cycloserine
D-Cycloserine: 50 mg/oral one hour prior to extinction task
|
Arm 3: Placebo
n=35 Participants
Placebo
Placebo: One hour prior to extinction task
|
|---|---|---|---|
|
Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)
Fear Extinction: End
|
.0013351 proportion of max SCR (µS)
Standard Error .0313355
|
-.026853 proportion of max SCR (µS)
Standard Error .0327715
|
.0854075 proportion of max SCR (µS)
Standard Error .0313355
|
|
Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)
Fear Conditioning: Beginning
|
.0325522 proportion of max SCR (µS)
Standard Error .0351212
|
.0245775 proportion of max SCR (µS)
Standard Error .0367306
|
-.0181339 proportion of max SCR (µS)
Standard Error .0328529
|
|
Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)
Fear Conditioning: End
|
.1233174 proportion of max SCR (µS)
Standard Error .0351212
|
.1024914 proportion of max SCR (µS)
Standard Error .0367306
|
.1276977 proportion of max SCR (µS)
Standard Error .0328529
|
|
Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)
Fear Extinction: Beginning
|
.0298132 proportion of max SCR (µS)
Standard Error .0313355
|
.0674658 proportion of max SCR (µS)
Standard Error .0327715
|
.1104578 proportion of max SCR (µS)
Standard Error .0313355
|
|
Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)
Extinction Retention
|
-.0101856 proportion of max SCR (µS)
Standard Error .0388043
|
-.0248148 proportion of max SCR (µS)
Standard Error .0405825
|
.0985292 proportion of max SCR (µS)
Standard Error .0393708
|
Adverse Events
Arm 1: Hydrocortisone
Arm 2: D-Cycloserine
Arm 3: Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sabra Inslicht, Ph.D.
San Francisco VA Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place