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Trial record 97 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

Veteran Stress and Learning Study (VSL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00674570
Recruitment Status : Completed
First Posted : May 8, 2008
Results First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Stress Disorders, Posttraumatic
Interventions Drug: Hydrocortisone
Drug: D-Cycloserine
Drug: Placebo
Enrollment 111
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Arm 1: Hydrocortisone Arm 2: D-Cycloserine Arm 3: Placebo
Hide Arm/Group Description

Hydrocortisone

Hydrocortisone: 25 mg/oral one hour prior to extinction task

D-Cycloserine

D-Cycloserine: 50 mg/oral one hour prior to extinction task

Placebo

Placebo: One hour prior to extinction task

Period Title: Overall Study
Started [1] 37 34 35
Completed 37 32 35
Not Completed 0 2 0
Reason Not Completed
Withdrawal by Subject             0             2             0
[1]
5 participants dropped out between screening and randomization to group.
Arm/Group Title Arm 1: Hydrocortisone Arm 2: D-Cycloserine Arm 3: Placebo Total
Hide Arm/Group Description

Hydrocortisone

Hydrocortisone: 25 mg/oral one hour prior to extinction task

D-Cycloserine

D-Cycloserine: 50 mg/oral one hour prior to extinction task

Placebo

Placebo: One hour prior to extinction task

Total of all reporting groups
Overall Number of Baseline Participants 37 34 35 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 34 participants 35 participants 106 participants
36.0  (12.8) 41.1  (13.7) 40.0  (11.8) 38.6  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 34 participants 35 participants 106 participants
Female
23
  62.2%
21
  61.8%
18
  51.4%
62
  58.5%
Male
14
  37.8%
13
  38.2%
17
  48.6%
44
  41.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 34 participants 35 participants 106 participants
Hispanic or Latino
7
  18.9%
4
  11.8%
7
  20.0%
18
  17.0%
Not Hispanic or Latino
30
  81.1%
30
  88.2%
28
  80.0%
88
  83.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 34 participants 35 participants 106 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   8.1%
4
  11.8%
1
   2.9%
8
   7.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  13.5%
6
  17.6%
7
  20.0%
18
  17.0%
White
22
  59.5%
21
  61.8%
25
  71.4%
68
  64.2%
More than one race
7
  18.9%
3
   8.8%
2
   5.7%
12
  11.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 37 participants 34 participants 35 participants 106 participants
37
 100.0%
34
 100.0%
35
 100.0%
106
 100.0%
1.Primary Outcome
Title Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)
Hide Description 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.
Time Frame 15 minute measurement intervals on Study Days 7, 9, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Hydrocortisone Arm 2: D-Cycloserine Arm 3: Placebo
Hide Arm/Group Description:

Hydrocortisone

Hydrocortisone: 25 mg/oral one hour prior to extinction task

D-Cycloserine

D-Cycloserine: 50 mg/oral one hour prior to extinction task

Placebo

Placebo: One hour prior to extinction task

Overall Number of Participants Analyzed 37 32 35
Mean (Standard Error)
Unit of Measure: proportion of max SCR (µS)
Fear Conditioning: Beginning .0325522  (.0351212) .0245775  (.0367306) -.0181339  (.0328529)
Fear Conditioning: End .1233174  (.0351212) .1024914  (.0367306) .1276977  (.0328529)
Fear Extinction: Beginning .0298132  (.0313355) .0674658  (.0327715) .1104578  (.0313355)
Fear Extinction: End .0013351  (.0313355) -.026853  (.0327715) .0854075  (.0313355)
Extinction Retention -.0101856  (.0388043) -.0248148  (.0405825) .0985292  (.0393708)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 2: D-Cycloserine, Arm 3: Placebo
Comments Fear Conditioning Beginning (first trial)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.66
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -.02
Confidence Interval (2-Sided) 95%
-.15 to .10
Parameter Dispersion
Type: Standard Error of the Mean
Value: .06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1: Hydrocortisone, Arm 3: Placebo
Comments Fear Conditioning Beginning (first trial)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.41
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -.05
Confidence Interval (2-Sided) 95%
-.17 to .07
Parameter Dispersion
Type: Standard Error of the Mean
Value: .06
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm 2: D-Cycloserine, Arm 3: Placebo
Comments Fear Conditioning End (last trial)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.43
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value .05
Confidence Interval (2-Sided) 95%
-.07 to .18
Parameter Dispersion
Type: Standard Error of the Mean
Value: .06
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm 1: Hydrocortisone, Arm 3: Placebo
Comments Fear Conditioning End (last trial)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.47
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value .04
Confidence Interval (2-Sided) 95%
-.07 to .17
Parameter Dispersion
Type: Standard Error of the Mean
Value: .06
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Arm 1: Hydrocortisone, Arm 3: Placebo
Comments Fear Extinction Beginning (first trial)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.065
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value .09
Confidence Interval (2-Sided) 95%
-.01 to .20
Parameter Dispersion
Type: Standard Error of the Mean
Value: .05
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Arm 2: D-Cycloserine, Arm 3: Placebo
Comments Fear Extinction Beginning (first trial)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.34
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value .05
Confidence Interval (2-Sided) 95%
-.05 to .15
Parameter Dispersion
Type: Standard Error of the Mean
Value: .05
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Arm 2: D-Cycloserine, Arm 3: Placebo
Comments Extinction End (last trial)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.003
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value .16
Confidence Interval (2-Sided) 95%
.06 to .26
Parameter Dispersion
Type: Standard Error of the Mean
Value: .05
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Arm 1: Hydrocortisone, Arm 3: Placebo
Comments Extinction End (last trial)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value .12
Confidence Interval (2-Sided) 95%
.02 to .22
Parameter Dispersion
Type: Standard Error of the Mean
Value: .05
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Arm 2: D-Cycloserine, Arm 3: Placebo
Comments Extinction Retention (first 2 trials) First trials were selected as a test of extinction retention, since repeated presentations of the CS without a UCS were expected to result in additional fear extinction.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.006
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value .18
Confidence Interval (2-Sided) 95%
.05 to .30
Parameter Dispersion
Type: Standard Error of the Mean
Value: .06
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Arm 1: Hydrocortisone, Arm 3: Placebo
Comments Extinction retention
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value .16
Confidence Interval (2-Sided) 95%
.04 to .28
Parameter Dispersion
Type: Standard Error of the Mean
Value: .06
Estimation Comments [Not Specified]
Time Frame Approximately, one month for each participant during their enrollment in the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Hydrocortisone Arm 2: D-Cycloserine Arm 3: Placebo
Hide Arm/Group Description

Hydrocortisone

Hydrocortisone: 25 mg/oral one hour prior to extinction task

D-Cycloserine

D-Cycloserine: 50 mg/oral one hour prior to extinction task

Placebo

Placebo: One hour prior to extinction task

All-Cause Mortality
Arm 1: Hydrocortisone Arm 2: D-Cycloserine Arm 3: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/32 (0.00%)   0/35 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Hydrocortisone Arm 2: D-Cycloserine Arm 3: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/32 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Hydrocortisone Arm 2: D-Cycloserine Arm 3: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/32 (0.00%)   0/35 (0.00%) 
Technical difficulties rendered corrugator electromyogram data unusable for analysis. We selected skin conductance as a primary measure of sympathetic activity rather than heart rate, which has both sympathetic and parasympathetic influences.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Sabra Inslicht, Ph.D.
Organization: San Francisco VA Health Care System
Phone: 415-221-4810 ext 23341
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00674570     History of Changes
Other Study ID Numbers: CDA-2-037-07F
H841-31915-01A ( Other Identifier: San Francisco VAMC )
First Submitted: May 6, 2008
First Posted: May 8, 2008
Results First Submitted: March 22, 2019
Results First Posted: May 30, 2019
Last Update Posted: May 30, 2019