Trial Outcomes & Findings for Extinction of Fear Memories With Glucocorticoids in Veterans With PTSD (NCT NCT01090180)
NCT ID: NCT01090180
Last Updated: 2016-11-25
Results Overview
The PCL is a 17-item measure of PTSD symptom severity with a range from 17-85. Each item is rated from 1-5 with higher scores are indicative of higher symptom severity. Scores of the 17 items are summed in order to generate the total score.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
129 participants
Primary outcome timeframe
This measure will be administered at all study visits: Baseline, 1 month, 3 months, and 6 months follow up.
Results posted on
2016-11-25
Participant Flow
67 participants excluded from initial recruitment sample for the following reasons: baseline assessment inclusion criteria not met (n = 18), declined enrollment post-consent (n = 1), exclusion criteria met (n = 26), lost to follow-up (n = 24).
Participant milestones
| Measure |
Arm 1: Dexamethasone
Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
|
Arm 2: Placebo
Placebo (sugar pill): inactive
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
29
|
|
Overall Study
COMPLETED
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extinction of Fear Memories With Glucocorticoids in Veterans With PTSD
Baseline characteristics by cohort
| Measure |
Arm 1: Dexamethasone
n=33 Participants
Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
|
Arm 2: Placebo
n=29 Participants
Placebo (sugar pill): inactive
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.91 years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
41.34 years
STANDARD_DEVIATION 13.97 • n=7 Participants
|
37.92 years
STANDARD_DEVIATION 12.78 • 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
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Hispanic
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Declined to state
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
29 participants
n=7 Participants
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: This measure will be administered at all study visits: Baseline, 1 month, 3 months, and 6 months follow up.Population: Male veterans with combat-related PTSD
The PCL is a 17-item measure of PTSD symptom severity with a range from 17-85. Each item is rated from 1-5 with higher scores are indicative of higher symptom severity. Scores of the 17 items are summed in order to generate the total score.
Outcome measures
| Measure |
Arm 1: Dexamethasone
n=33 Participants
Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
|
Arm 2: Placebo
n=29 Participants
Placebo (sugar pill): inactive
|
|---|---|---|
|
PTSD Checklist (PCL). A Self-report, Face Valid Measure of PTSD Symptoms Over a 1 Week Time Period
Baseline
|
55.76 units on a scale
Standard Deviation 10.17
|
54.83 units on a scale
Standard Deviation 12.19
|
|
PTSD Checklist (PCL). A Self-report, Face Valid Measure of PTSD Symptoms Over a 1 Week Time Period
1-month follow up
|
50.14 units on a scale
Standard Deviation 13.35
|
51.57 units on a scale
Standard Deviation 11.36
|
|
PTSD Checklist (PCL). A Self-report, Face Valid Measure of PTSD Symptoms Over a 1 Week Time Period
3-month follow up
|
45.45 units on a scale
Standard Deviation 13.80
|
51.89 units on a scale
Standard Deviation 12.39
|
|
PTSD Checklist (PCL). A Self-report, Face Valid Measure of PTSD Symptoms Over a 1 Week Time Period
6-month follow up
|
58.57 units on a scale
Standard Deviation 13.72
|
48.17 units on a scale
Standard Deviation 12.53
|
SECONDARY outcome
Timeframe: This measure will be administered at all study visits: Baseline, 1 month, 3 months, and 6 months follow up.The QIDS-SR is a 16-item measure of depression symptom severity with a range from 0-27. Each item is rated from 0-3 with higher scores are indicative of higher symptom severity. Scores of the items are aggregated (with the highest score on overlapping items chosen; e.g., sleep disturbances, changes in eating) to generate the total score..
Outcome measures
| Measure |
Arm 1: Dexamethasone
n=33 Participants
Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
|
Arm 2: Placebo
n=29 Participants
Placebo (sugar pill): inactive
|
|---|---|---|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR). Because Depression Can be Comorbid With PTSD (70% Comorbidity Found in Pilot Sample), This Assessment Will be Used to Measure Depressive Symptoms Over a 1 Week Timeframe
Baseline
|
13.55 units on a scale
Standard Deviation 4.59
|
12.86 units on a scale
Standard Deviation 3.36
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR). Because Depression Can be Comorbid With PTSD (70% Comorbidity Found in Pilot Sample), This Assessment Will be Used to Measure Depressive Symptoms Over a 1 Week Timeframe
1-month follow up
|
10.68 units on a scale
Standard Deviation 4.36
|
10.71 units on a scale
Standard Deviation 3.54
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR). Because Depression Can be Comorbid With PTSD (70% Comorbidity Found in Pilot Sample), This Assessment Will be Used to Measure Depressive Symptoms Over a 1 Week Timeframe
3-month follow up
|
11.38 units on a scale
Standard Deviation 5.12
|
11.32 units on a scale
Standard Deviation 3.59
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR). Because Depression Can be Comorbid With PTSD (70% Comorbidity Found in Pilot Sample), This Assessment Will be Used to Measure Depressive Symptoms Over a 1 Week Timeframe
6-month follow up
|
11.00 units on a scale
Standard Deviation 5.62
|
10.33 units on a scale
Standard Deviation 3.68
|
Adverse Events
Arm 1: Dexamethasone
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Dexamethasone
n=33 participants at risk
Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
|
Arm 2: Placebo
n=29 participants at risk
Placebo (sugar pill): inactive
|
|---|---|---|
|
Infections and infestations
Presented to ER with swelling in leg
|
3.0%
1/33 • Number of events 1
|
0.00%
0/29
|
Other adverse events
Adverse event data not reported
Additional Information
Alina Suris
Veterans Affairs North Texas Health Care System
Phone: 817-715-0625
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place