A Trial of Prazosin for Combat Trauma PTSD With Nightmares in Active-Duty Soldiers Returned From Iraq and Afghanistan
Abstract
Objective
Method
Results
Conclusions
Method
Participants
Inclusion and Exclusion Criteria
Randomization and Study Drug Titration
Men | Women | |||
---|---|---|---|---|
Week | Morning Dose (mg)a | Bedtime Dose (mg) | Morning Dose (mg)a | Bedtime Dose (mg) |
Week 1 | ||||
Days 1 and 2 | 1 | 1 | ||
Days 3–7 | 2 | 2 | ||
Week 2 | 1 | 4 | 1 | 2 |
Week 3 | 2 | 6 | 1 | 4 |
Week 4 | 2 | 10 | 2 | 6 |
Week 5 | 5 | 15 | 2 | 10 |
Week 6 | 5 | 20 |
Assessments
Results
Treatment Condition | ||||
---|---|---|---|---|
Characteristic | Prazosin (N=32) | Placebo (N=35) | ||
Mean | SD | Mean | SD | |
Age (years) | 30.0 | 6.6 | 30.8 | 6.5 |
Educationa (years) | 13.3 | 1.9 | 13.0 | 2.1 |
Combat Experiences Scale score | 10.9 | 3.8 | 11.9 | 3.6 |
Number of deployments | 2.6 | 4.0 | 1.9 | 1.2 |
N | % | N | % | |
Male | 26 | 81 | 31 | 89 |
Race/ethnicity | ||||
African American | 4 | 13 | 5 | 14 |
Asian | 1 | 3 | 0 | |
Caucasian | 21 | 66 | 21 | 60 |
Hispanic | 5 | 16 | 3 | 9 |
Native American | 0 | 2 | 6 | |
Other | 1 | 3 | 4 | 11 |
Marital status | ||||
Married | 19 | 59 | 26 | 74 |
Widowed | 1 | 3 | 0 | |
Separated/divorced | 8 | 25 | 5 | 14 |
Never married | 4 | 13 | 4 | 11 |
Major depression | 11 | 34 | 15 | 43 |
Maintained on any antidepressant | 10 | 31b | 14 | 40c |
Maintained on SSRI | 7 | 22 | 13 | 37 |
Treatment Group | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Prazosin (N=32)b | Placebo (N=35)b | Difference in | ||||||||||
Behavioral Outcome | Baseline | Week 15 | Baseline | Week 15 | Change From Baselinec | t | p | |||||
Mean | 95% CI | Mean | 95% CI | Mean | 95% CI | Mean | 95% CI | Mean | 95% CI | |||
CAPS nightmare item | 6.0 | 5.4, 6.6 | 2.9 | 2.2, 3.5 | 6.6 | 6.0, 7.2 | 5.4 | 4.8, 6.0 | 1.9 | 1.0, 2.8 | 4.06 | <0.001 |
Pittsburgh Sleep Quality Index | 14.1 | 12.8, 15.5 | 8.5 | 7.1, 9.9 | 14.5 | 13.2, 15.7 | 11.6 | 10.3, 13.0 | 2.8 | 0.9, 4.7 | 2.98 | 0.003 |
Clinical Global Impressions Scale change item | 2.3 | 1.8, 2.7 | 3.2 | 2.8, 3.6 | 0.9 | 0.3, 1.5 | 3.13 | 0.003 | ||||
CAPS total score | 77.3 | 69.1, 85.5 | 52.2 | 43.8, 60.5 | 85.7 | 78.0, 93.3 | 71.9 | 63.9, 79.8 | 11.3 | 2.0, 20.7 | 2.39 | 0.02 |
CAPS total score without nightmare item | 71.3 | 63.5, 79.1 | 49.3 | 41.3, 57.3 | 79.0 | 71.7, 86.4 | 66.5 | 58.9, 74.1 | 9.5 | 0.7, 18.3 | 2.12 | 0.04 |
CAPS reexperiencing cluster | 22.3 | 19.8, 24.7 | 15.5 | 13.0, 18.0 | 25.1 | 22.7, 27.4 | 20.6 | 18.2, 23.1 | 2.3 | –1.2, 5.8 | 1.31 | 0.19 |
CAPS avoidance cluster | 26.8 | 22.6, 31.0 | 18.2 | 13.9, 22.5 | 29.9 | 25.9, 33.8 | 24.7 | 20.6, 28.8 | 3.5 | –0.3, 7.3 | 1.81 | 0.07 |
CAPS hyperarousal cluster | 28.2 | 25.7, 30.6 | 18.3 | 15.8, 20.8 | 30.7 | 28.4, 33.0 | 26.2 | 23.8, 28.7 | 5.4 | 1.9, 8.9 | 3.05 | 0.003 |
Hamilton Depression Rating Scale | 11.9 | 9.5, 14.3 | 10.0 | 7.5, 12.5 | 14.7 | 12.4, 17.0 | 14.7 | 12.3, 17.1 | 2.0 | –0.8, 4.8 | 1.39 | 0.17 |
Patient Health Questionnaire–9 | 12.1 | 9.9, 14.3 | 7.2 | 4.9, 9.4 | 14.7 | 12.6, 16.8 | 11.6 | 9.5, 13.8 | 1.8 | –0.5, 4.2 | 1.53 | 0.13 |
Blood pressure (mmHg) | ||||||||||||
Supine systolic | 126 | 123, 130 | 128 | 124, 131 | 126 | 123, 129 | 127 | 124, 130 | 0.1 | –4.1, 4.2 | 0.04 | 0.96 |
Supine diastolic | 80 | 77, 83 | 81 | 78, 84 | 81 | 79, 84 | 82 | 79, 85 | –0.6 | –4.3, 3.2 | –0.29 | 0.78 |
Standing systolic | 123 | 120, 126 | 124 | 120, 128 | 125 | 121, 128 | 124 | 121, 128 | –1.3 | –6.5, 3.8 | –0.51 | 0.61 |
Standing diastolic | 82 | 79, 85 | 83 | 80, 86 | 84 | 81, 86 | 84 | 81, 87 | –0.9 | –4.8, 3.0 | –0.46 | 0.64 |
Discussion
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