18 and older, any sex, with PTSD or Sleep Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
CAPS Recurrent Distressing Dreams ItemPrimary· This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.
Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.
Group
Value
95% CI
Prazosin Group
-1.9
± 2.1
Placebo Group
-1.7
± 2.3
Pittsburgh Sleep Quality Index (PSQI)Primary· This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.
Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.
Group
Value
95% CI
Prazosin
-2.3
± 4.2
Placebo
-2.1
± 4
Pittsburgh Sleep Quality IndexSecondary· This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).
Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.
Baseline
Group
Value
95% CI
Prazosin
14.4
± 3.3
Placebo
14.7
± 3.5
Change at Week 6
Group
Value
95% CI
Prazosin
-2.1
± 3.9
Placebo
-2.4
± 4.2
Change at Week 10
Group
Value
95% CI
Prazosin
-2.3
± 4.2
Placebo
-2.1
± 4
Change at Week 14
Group
Value
95% CI
Prazosin
-3.1
± 3.9
Placebo
-2.7
± 3.9
Change at Week 18
Group
Value
95% CI
Prazosin
-2.4
± 4.1
Placebo
-2.8
± 4
Change at Week 22
Group
Value
95% CI
Prazosin
-2.9
± 4
Placebo
-2.7
± 4.2
Change at Week 26
Group
Value
95% CI
Prazosin
-2.9
± 4.3
Placebo
-2.7
± 4.1
CAPS Recurrent Distressing Dreams ItemSecondary· This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination) to assess temporal course of changes in symptoms in response to prazosin or placebo.
Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.
Baseline
Group
Value
95% CI
Prazosin Group
6.3
± 0.9
Placebo Group
6.3
± 0.9
Change at Week 6
Group
Value
95% CI
Prazosin Group
-1.3
± 1.8
Placebo Group
-1.4
± 1.8
Change at Week 10
Group
Value
95% CI
Prazosin Group
-1.9
± 2.1
Placebo Group
-1.7
± 2.3
Change at Week 14
Group
Value
95% CI
Prazosin Group
-2.2
± 2.2
Placebo Group
-2.5
± 2.5
Change at Week 18
Group
Value
95% CI
Prazosin Group
-1.8
± 2.3
Placebo Group
-2.4
± 2.5
Change at Week 22
Group
Value
95% CI
Prazosin Group
-2.4
± 2.3
Placebo Group
-2.5
± 2.4
Change at Week 26
Group
Value
95% CI
Prazosin Group
-2.3
± 2.5
Placebo Group
-2.2
± 2.5
Clinical Global Impression of ChangeSecondary· This secondary outcome measure was administered at 6, 10, 14, 18, 22 and 26 weeks (or early termination).
Change from baseline in possible range for Clinical Global Impression of Change (CGIC) 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.
Week 6
Group
Value
95% CI
Prazosin
3.2
± 1.2
Placebo
3.3
± 1.3
Week 10
Group
Value
95% CI
Prazosin
3.3
± 1.4
Placebo
3.3
± 1.4
Week 14
Group
Value
95% CI
Prazosin
3
± 1.4
Placebo
3
± 1.4
Week 18
Group
Value
95% CI
Prazosin
3.2
± 1.3
Placebo
3
± 1.4
Week 22
Group
Value
95% CI
Prazosin
2.9
± 1.4
Placebo
2.9
± 1.3
Week 26
Group
Value
95% CI
Prazosin
2.9
± 1.6
Placebo
2.9
± 1.4
Total CAPS ScoreSecondary· The total CAPS was administered at baseline, 6, 10, 18, and 26 weeks (or early termination).
Change from baseline in possible range for CAPS total score is 0-136. Higher score indicates more severe PTSD symptoms.
Baseline
Group
Value
95% CI
Prazosin
80.7
± 15.5
Placebo
81.9
± 17.1
Change at Week 6
Group
Value
95% CI
Prazosin
-9.9
± 16
Placebo
-9.1
± 16.9
Change at Week 10
Group
Value
95% CI
Prazosin
-11.4
± 17.2
Placebo
-12.1
± 19.4
Change at Week 18
Group
Value
95% CI
Prazosin
-11.6
± 18.3
Placebo
-17.2
± 21.7
Change at Week 26
Group
Value
95% CI
Prazosin
-14.1
± 21.8
Placebo
-16.2
± 24.2
Clinical Global Impression of Change (CGIC)Primary· This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.
Change from baseline in possible range for Clinical Global Impression of Change 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.
Group
Value
95% CI
Prazosin
3.3
± 1.4
Placebo
3.3
± 1.4
PTSD Checklist-Military Version (PCL-M) ScoreSecondary· This secondary outcome was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks to assess change in PTSD symptom severity.
Change from baseline in possible range for PCL-M score 17-85. Higher PCL score indicates greater propensity for chronic and delayed PTSD.
Baseline
Group
Value
95% CI
Prazosin
62.5
± 11.1
Placebo
64.3
± 12.2
Change at Week 6
Group
Value
95% CI
Prazosin
-6.3
± 10.6
Placebo
-6.2
± 11
Change at Week 10
Group
Value
95% CI
Prazosin
-7
± 12.7
Placebo
-5.8
± 11.6
Change at Week 14
Group
Value
95% CI
Prazosin
-8.1
± 12.5
Placebo
-7.6
± 11.6
Change at Week 18
Group
Value
95% CI
Prazosin
-7.2
± 12.3
Placebo
-8.4
± 13.3
Change at Week 22
Group
Value
95% CI
Prazosin
-7.1
± 12.9
Placebo
-9.2
± 13.5
Change at Week 26
Group
Value
95% CI
Prazosin
-8.2
± 13.8
Placebo
-9.7
± 14
Patient Health Questionnaire-9 (PHQ9)Secondary· This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).
Change from baseline in possible range for PHQ9 score is 0-27. Higher PHQ9 score indicates more severe depression.
Baseline
Group
Value
95% CI
Prazosin
13.7
± 5.9
Placebo
14.6
± 5.9
Change at Week 6
Group
Value
95% CI
Prazosin
-1.6
± 4.7
Placebo
-2.8
± 5.1
Change at Week 10
Group
Value
95% CI
Prazosin
-1.9
± 5.1
Placebo
-2.2
± 5.1
Change at Week 14
Group
Value
95% CI
Prazosin
-1.9
± 5.2
Placebo
-2.6
± 5.3
Change at Week 18
Group
Value
95% CI
Prazosin
-1.6
± 5.3
Placebo
-2.4
± 5.5
Change at Week 22
Group
Value
95% CI
Prazosin
-2.2
± 5.6
Placebo
-2.5
± 5.9
Change at Week 26
Group
Value
95% CI
Prazosin
-2
± 5.5
Placebo
-2.8
± 5.8
SF-12 Physical Standardized Score (SF-12 PCS)Secondary· This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).
Change from baseline in possible range for SF-12 PCS is 6-72. Higher SF-12 score indicates better level of health.
Baseline
Group
Value
95% CI
Prazosin
35.4
± 14.5
Placebo
34.2
± 12.2
Change at Week 6
Group
Value
95% CI
Prazosin
1.8
± 9.7
Placebo
0.8
± 10.2
Change at Week 10
Group
Value
95% CI
Prazosin
0.3
± 10
Placebo
0.3
± 10.4
Change at Week 14
Group
Value
95% CI
Prazosin
1.4
± 10.1
Placebo
0.3
± 10.9
Change at Week 18
Group
Value
95% CI
Prazosin
0.5
± 10
Placebo
-0.4
± 11.4
Change at Week 22
Group
Value
95% CI
Prazosin
1.1
± 10.9
Placebo
-0.8
± 13.2
Change at Week 26
Group
Value
95% CI
Prazosin
0.7
± 11.8
Placebo
-0.2
± 11.9
SF-12 Mental Standardized Score (SF-12 MCS)Secondary· This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).
Change from baseline in possible range for SF-12 MCS is 5-76. Higher SF-12 score indicates better level of health.
Baseline
Group
Value
95% CI
Prazosin
38.2
± 9.1
Placebo
39.4
± 8.4
Change at Week 6
Group
Value
95% CI
Prazosin
-2
± 9.2
Placebo
-1.3
± 8.5
Change at Week 10
Group
Value
95% CI
Prazosin
-1
± 9.2
Placebo
-1.1
± 8.7
Change at Week 14
Group
Value
95% CI
Prazosin
-1.5
± 7.9
Placebo
-1
± 9.7
Change at Week 18
Group
Value
95% CI
Prazosin
-0.2
± 8.4
Placebo
-0.7
± 8.8
Change at Week 22
Group
Value
95% CI
Prazosin
-0.8
± 8.9
Placebo
-0.6
± 9.4
Change at Week 26
Group
Value
95% CI
Prazosin
-0.7
± 8.7
Placebo
-0.8
± 9.5
Quality of Life Inventory (QOLI)Secondary· This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).
Change from baseline in possible range for QOLI is -6 to 6. Higher QOLI indicates better satisfaction with life.
Baseline
Group
Value
95% CI
Prazosin
0.1
± 1.9
Placebo
0
± 1.9
Change at Week 6
Group
Value
95% CI
Prazosin
0.1
± 1.5
Placebo
0
± 1.4
Change at Week 10
Group
Value
95% CI
Prazosin
0
± 1.3
Placebo
0.1
± 1.7
Change at Week 14
Group
Value
95% CI
Prazosin
0.1
± 1.5
Placebo
0
± 1.5
Change at Week 18
Group
Value
95% CI
Prazosin
0.3
± 1.3
Placebo
0.1
± 1.6
Change at Week 22
Group
Value
95% CI
Prazosin
0.1
± 1.4
Placebo
0.1
± 1.9
Change at Week 26
Group
Value
95% CI
Prazosin
0.2
± 1.4
Placebo
0.2
± 2
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Prazosin Group
Serious: 18/152 (12%)
Deaths: —
Placebo Group
Serious: 17/152 (11%)
Deaths: —
Serious adverse events (30 terms)
Reaction
System
Prazosin Group
Placebo Group
Suicidal ideation
Psychiatric disorders
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Coronary artery disease
Cardiac disorders
—
—
Myocardial infarction
Cardiac disorders
—
—
Arteriovenous malformation
Cardiac disorders
—
—
Retinal detachment
Eye disorders
—
—
Abdominal hernia
Gastrointestinal disorders
—
—
Haemorrhagic erosive gastritis
Gastrointestinal disorders
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
Chest pain
General disorders
—
—
Drug withdrawal syndrome
General disorders
—
—
Campylobacter infection
Infections and infestations
—
—
Cellulitis
Infections and infestations
—
—
Pneumonia
Infections and infestations
—
—
Ankle fracture
Injury, poisoning and procedural complications
—
—
Arthropod sting
Injury, poisoning and procedural complications
—
—
Delayed recovery from anaesthesia
Injury, poisoning and procedural complications
—
—
Endotracheal intubation complication
Injury, poisoning and procedural complications
—
—
Fall
Injury, poisoning and procedural complications
—
—
Road traffic accident
Injury, poisoning and procedural complications
—
—
Toxicity to various agents
Injury, poisoning and procedural complications
—
—
Fracture malunion
Musculoskeletal and connective tissue disorders
—
—
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
—
—
Basal ganglia infarction
Nervous system disorders
—
—
Sudden onset of sleep
Nervous system disorders
—
—
Other adverse events (245 terms — click to expand)
Background: Posttraumatic stress disorder (PTSD) is a debilitating and disabling mental disorder that afflicts at least 25% of Veterans who have suffered life-threatening war zone trauma. Trauma-related nightmares and sleep disturbance are among the most treatment-resistant PTSD symptoms in Veterans. Increased responsiveness to central nervous system (CNS) norepinephrine (NE) contributes to the pathophysiology of overall PTSD and treatment-resistant nighttime symptoms. Placebo-controlled pilot studies demonstrate that the generically available CNS-active alpha-1 adrenoreceptor antagonist prazosin substantially reduces PTSD trauma nightmares and sleep disturbance and improves global clinical status (sense of well being and ability to function) in Veterans.
Objective: The primary objective is to demonstrate in a large multi-site placebo-controlled trial in Veterans with war zone trauma-induced PTSD that prazosin is efficacious for PTSD trauma nightmares, sleep disturbance, and global clinical status. A secondary objective is to demonstrate prazosin effectiveness for these outcome measures during clinically meaningful long-term (26 week) maintenance treatment of PTSD. The investigators will also address prazosin efficacy and long-term effectiveness for improving total PTSD symptoms, comorbid depression, quality of life, and physical functioning.
Methods: This 26 week randomized double-blind placebo-controlled study is designed to demonstrate both short term efficacy and long term effectiveness of prazosin for PTSD. The research design encompasses a shorter-term, more tightly controlled efficacy component and a longer-term, more .real world. effectiveness component. Three hundred twenty-six Veterans with war zone -related PTSD and persistent trauma nightmares will be randomized 1:1 to prazosin or placebo. Study drug will be increased using a flexible dose titration schedule based on clinical response and adverse effects to an optimum maintenance dose (1-20 mg/day). During the first 10 weeks of the study, participants will be randomized to prazosin or placebo. Previous psychotropic medications and/or psychotherapy will be maintained constant. Short term efficacy will be determined during the first 10 weeks. During the remaining 16 weeks of the 26 week trial, subjects will continue to receive stable-dose double-blind prazosin or placebo, but will have the option to receive additional psychotropic medications and/or psychotherapeutic interventions, as needed, per the judgment of the study Clinician Prescriber. It is hypothesized that prazosin will remain more clinically effective than placebo at the end of the 26-week trial, demonstrating that prazosin adds benefit over-and-above other treatments that are naturalistically administered by providers in a .real world. clinical setting.
Prazosin will be judged efficacious at 10 weeks if superior to placebo on all three primary outcome measures assessing trauma nightmares, sleep disturbance, and global clinical status: the Recurrent Distressing Dreams item of the Clinician Administered PTSD Scale (CAPS), the Pittsburgh Sleep Quality Index (PSQI), and the Clinical Global Impression of Change (CGIC). Secondary outcome measures will assess prazosin effects on total PTSD symptoms, depression, physical functioning, and quality of life. Adverse effects and cardiovascular measures, including supine and standing blood pressure (BP) and heart rate (HR) will be assessed.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 1 May 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00532493.