Trial Outcomes & Findings for Short Course Glucocorticoid Treatment for PTSD (NCT NCT00204737)
NCT ID: NCT00204737
Last Updated: 2020-05-06
Results Overview
This measure tests the hypothesis that there will be a 30% or greater improvement in the Clinician-Administered PTSD (Post Traumatic Stress Disorder) Scale over the course of the study. CAPS is a 30-item survey with a total possible range of scores from 0-120 where the higher the score, the more severe the symptoms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
baseline, 2 weeks, 6 weeks, 12 weeks
Results posted on
2020-05-06
Participant Flow
Participant milestones
| Measure |
Prednisone
Prednisone 20mg daily x 2 weeks
prednisone: 20mg x 2 weeks
|
Placebo
placebo
placebo: placebo
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Short Course Glucocorticoid Treatment for PTSD
Baseline characteristics by cohort
| Measure |
Prednisone
n=6 Participants
Prednisone 20mg daily x 2 weeks
prednisone: 20mg x 2 weeks
|
Placebo
n=6 Participants
placebo
placebo: placebo
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
54 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Marital Status
Married
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Trauma Type
Combat
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Trauma Type
Childhood Abuse
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Trauma Type
Employment
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education Level
High School / GED
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Education Level
Some College
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education Level
Bachelor's or Technical School
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Percent Service Connection
0 percent
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Percent Service Connection
1-30 percent
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Percent Service Connection
31-60 percent
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Percent Service Connection
61-99 percent
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Percent Service Connection
100 percent
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 2 weeks, 6 weeks, 12 weeksThis measure tests the hypothesis that there will be a 30% or greater improvement in the Clinician-Administered PTSD (Post Traumatic Stress Disorder) Scale over the course of the study. CAPS is a 30-item survey with a total possible range of scores from 0-120 where the higher the score, the more severe the symptoms.
Outcome measures
| Measure |
Prednisone
n=6 Participants
Prednisone 20mg daily x 2 weeks
prednisone: 20mg x 2 weeks
|
Placebo
n=6 Participants
placebo
placebo: placebo
|
|---|---|---|
|
Change in Clinician-Administered PTSD Scale (CAPS)
Baseline
|
96.0 score on a scale
Standard Deviation 17.1
|
90.7 score on a scale
Standard Deviation 13.3
|
|
Change in Clinician-Administered PTSD Scale (CAPS)
2 Weeks
|
66.3 score on a scale
Standard Deviation 18.6
|
86.2 score on a scale
Standard Deviation 21.0
|
|
Change in Clinician-Administered PTSD Scale (CAPS)
6 Weeks
|
72.8 score on a scale
Standard Deviation 18.2
|
81.5 score on a scale
Standard Deviation 11.6
|
|
Change in Clinician-Administered PTSD Scale (CAPS)
12 Weeks
|
75.2 score on a scale
Standard Deviation 27.0
|
82.5 score on a scale
Standard Deviation 18.7
|
PRIMARY outcome
Timeframe: baseline, 2 weeks, 6 weeks, 12 weeksCAPS response defined as a 30% reduction in CAPS score from baseline.
Outcome measures
| Measure |
Prednisone
n=6 Participants
Prednisone 20mg daily x 2 weeks
prednisone: 20mg x 2 weeks
|
Placebo
n=6 Participants
placebo
placebo: placebo
|
|---|---|---|
|
Number of Participants Achieving CAPS Response
baseline to 2 weeks
|
4 Participants
|
0 Participants
|
|
Number of Participants Achieving CAPS Response
baseline to 6 weeks
|
3 Participants
|
0 Participants
|
|
Number of Participants Achieving CAPS Response
baseline to 12 weeks
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, 2 weeks, 6 weeks, 12 weeksHAM-D is a 21-item survey where scoring is based on the first 17-items. It has a total possible range of scores 0-50 where higher scores indicate more severe depression.
Outcome measures
| Measure |
Prednisone
n=6 Participants
Prednisone 20mg daily x 2 weeks
prednisone: 20mg x 2 weeks
|
Placebo
n=6 Participants
placebo
placebo: placebo
|
|---|---|---|
|
Change in Hamilton Depression Rating Scale (HAM-D)
Baseline
|
19.2 score on a scale
Standard Deviation 7.2
|
16.8 score on a scale
Standard Deviation 5.8
|
|
Change in Hamilton Depression Rating Scale (HAM-D)
2 Weeks
|
13.2 score on a scale
Standard Deviation 6.1
|
14.8 score on a scale
Standard Deviation 6.7
|
|
Change in Hamilton Depression Rating Scale (HAM-D)
6 Weeks
|
11.7 score on a scale
Standard Deviation 5.9
|
14.5 score on a scale
Standard Deviation 6.2
|
|
Change in Hamilton Depression Rating Scale (HAM-D)
12 Weeks
|
12.3 score on a scale
Standard Deviation 5.7
|
15.7 score on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: baseline, 2 weeks, 6 weeks, 12 weeksPCL-PTSD is a 17-item survey with a total possible range of scores 17-85 where higher scores indicate more severe symptoms.
Outcome measures
| Measure |
Prednisone
n=6 Participants
Prednisone 20mg daily x 2 weeks
prednisone: 20mg x 2 weeks
|
Placebo
n=6 Participants
placebo
placebo: placebo
|
|---|---|---|
|
Change in PCL-PTSD Score
Baseline
|
68.7 score on a scale
Standard Deviation 10.6
|
64.2 score on a scale
Standard Deviation 9.5
|
|
Change in PCL-PTSD Score
2 Weeks
|
58.8 score on a scale
Standard Deviation 7.5
|
59.8 score on a scale
Standard Deviation 8.0
|
|
Change in PCL-PTSD Score
6 Weeks
|
56.0 score on a scale
Standard Deviation 13.3
|
60.3 score on a scale
Standard Deviation 6.0
|
|
Change in PCL-PTSD Score
12 Weeks
|
58.2 score on a scale
Standard Deviation 15.6
|
64.2 score on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: baseline, 2 weeks, 6 weeks, 12 weeksCGI-S is scored by a clinician. It is a 7 point scale where 1 = normal, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill.
Outcome measures
| Measure |
Prednisone
n=6 Participants
Prednisone 20mg daily x 2 weeks
prednisone: 20mg x 2 weeks
|
Placebo
n=6 Participants
placebo
placebo: placebo
|
|---|---|---|
|
Change in Clinical Global Impression Severity (CGI-S) Score
Baseline
|
5.5 score on a scale
Standard Deviation 1.0
|
5.5 score on a scale
Standard Deviation 0.8
|
|
Change in Clinical Global Impression Severity (CGI-S) Score
2 Weeks
|
4.7 score on a scale
Standard Deviation 0.8
|
5.5 score on a scale
Standard Deviation 0.8
|
|
Change in Clinical Global Impression Severity (CGI-S) Score
6 Weeks
|
4.8 score on a scale
Standard Deviation 0.8
|
5.2 score on a scale
Standard Deviation 0.8
|
|
Change in Clinical Global Impression Severity (CGI-S) Score
12 Weeks
|
4.5 score on a scale
Standard Deviation 1.0
|
5.5 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, and 12 weeksDHEA-S measured at baseline, 2 weeks, 6 weeks, and 12 weeks
Outcome measures
| Measure |
Prednisone
n=6 Participants
Prednisone 20mg daily x 2 weeks
prednisone: 20mg x 2 weeks
|
Placebo
n=6 Participants
placebo
placebo: placebo
|
|---|---|---|
|
Change in Dehydroepiandrosterone Sulfate (DHEA-S)
2 Weeks
|
87.7 mcg/dl
Standard Deviation 105.6
|
148.7 mcg/dl
Standard Deviation 170.8
|
|
Change in Dehydroepiandrosterone Sulfate (DHEA-S)
Baseline
|
123.8 mcg/dl
Standard Deviation 115.0
|
201.2 mcg/dl
Standard Deviation 280.2
|
|
Change in Dehydroepiandrosterone Sulfate (DHEA-S)
6 Weeks
|
123.5 mcg/dl
Standard Deviation 116.2
|
156.8 mcg/dl
Standard Deviation 188.3
|
|
Change in Dehydroepiandrosterone Sulfate (DHEA-S)
12 Weeks
|
112.3 mcg/dl
Standard Deviation 117.4
|
157.8 mcg/dl
Standard Deviation 211.8
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, and 12 weeksPopulation: Midway through the study, the protocol related to salivary cortisol was modified to add the dexamethasone suppression test to better understand response of the hypothalamic pituitary adrenal (HPA) axis to a steroid challenge. This is why no participants were analyzed during week 2.
Outcome measures
| Measure |
Prednisone
n=3 Participants
Prednisone 20mg daily x 2 weeks
prednisone: 20mg x 2 weeks
|
Placebo
n=3 Participants
placebo
placebo: placebo
|
|---|---|---|
|
Change in Salivary Cortisol (First 6 Participants)
Baseline
|
0.13 ug/dl
Standard Deviation 0.05
|
0.08 ug/dl
Standard Deviation 0.03
|
|
Change in Salivary Cortisol (First 6 Participants)
6 Weeks
|
0.10 ug/dl
Standard Deviation 0.02
|
0.09 ug/dl
Standard Deviation 0.03
|
|
Change in Salivary Cortisol (First 6 Participants)
12 Weeks
|
0.10 ug/dl
Standard Deviation 0.01
|
0.07 ug/dl
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, and 12 weeksPopulation: One participant in the Prednisone arm did not provide enough sample for analysis and one additional participant in the Prednisone arm did not provide enough sample for analysis at week 6. Data was not collected for week 2 due to protocol amendment to change cortisol testing.
Participants provided saliva samples at 16:00, 24:00, and 08:00. After these samples are collected, participants take 0.5mg dexamethasone orally at 23:00, and a fourth sample is collected at 08:00 post dexamethasone. Post-dexamethasone data is reported here.
Outcome measures
| Measure |
Prednisone
n=2 Participants
Prednisone 20mg daily x 2 weeks
prednisone: 20mg x 2 weeks
|
Placebo
n=3 Participants
placebo
placebo: placebo
|
|---|---|---|
|
Change in Salivary Cortisol (Last 6 Participants)
Baseline
|
0.1 ug/dl
Standard Deviation 0.1
|
0.138 ug/dl
Standard Deviation 0.067
|
|
Change in Salivary Cortisol (Last 6 Participants)
6 Weeks
|
0.103 ug/dl
Standard Deviation NA
Only one data point.
|
0.157 ug/dl
Standard Deviation 0.021
|
|
Change in Salivary Cortisol (Last 6 Participants)
12 Weeks
|
0.112 ug/dl
Standard Deviation 0.122
|
0.183 ug/dl
Standard Deviation 0.067
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, and 12 weeksPopulation: Data no longer exists in the research file depository due it its vintage. Unable to report this measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 3 weeksThe Systematic Assessment for Treatment Emergent Events-General Inquiry (SAFTEE-GI) was used to collect and analyze data about potential medication related side effects. Each of 12 subjects was queried using the SAFTEE-GI at 3 time points (1, 2 and 3 weeks) for a possible of 36 adverse event reports.
Outcome measures
| Measure |
Prednisone
n=6 Participants
Prednisone 20mg daily x 2 weeks
prednisone: 20mg x 2 weeks
|
Placebo
n=6 Participants
placebo
placebo: placebo
|
|---|---|---|
|
Number of Other Adverse Events
Decreased Energy
|
0 incidence of adverse events
|
1 incidence of adverse events
|
|
Number of Other Adverse Events
Musculoskeletal
|
2 incidence of adverse events
|
1 incidence of adverse events
|
|
Number of Other Adverse Events
Sleeplessness
|
3 incidence of adverse events
|
0 incidence of adverse events
|
|
Number of Other Adverse Events
Reduced Blood Sugar
|
2 incidence of adverse events
|
0 incidence of adverse events
|
|
Number of Other Adverse Events
Upper Respiratory Infection
|
1 incidence of adverse events
|
1 incidence of adverse events
|
|
Number of Other Adverse Events
Increased Mood
|
1 incidence of adverse events
|
0 incidence of adverse events
|
|
Number of Other Adverse Events
Mild Urinary Hesitancy
|
0 incidence of adverse events
|
1 incidence of adverse events
|
Adverse Events
Prednisone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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