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| ID | Type | Description | Link |
|---|---|---|---|
| 1P20AA017839-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| VA Puget Sound Health Care System | FED |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The purpose of this study is to determine whether prazosin will:
This is a 15-week randomized parallel design, double-blind, placebo-controlled augmentation trial of prazosin to evaluate the efficacy and tolerability of prazosin augmentation in the treatment of PTSD trauma-related nightmares, sleep disturbance, global function and sense of well-being, and other clinical features and comorbidities of PTSD. Participants will be 210 OIF/OEF soldiers and veterans who have suffered war zone trauma. Participants will be randomized 1:1 to prazosin or placebo and all previous psychotropic medications and/or psychotherapy will be maintained constant. Randomization will be stratified by site and use of an antidepressant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prazosin hydrochloride | Active Comparator | prazosin Pfizer Minipress oral capsules Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. |
|
| placebo | Placebo Comparator | placebo oral capsules Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prazosin hydrochloride | Drug | Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item | Item B-2 "recurrent distressing dreams of the event" is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 15. | Baseline to Week 15 |
| Change in Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 15. | Baseline to Week 15 |
| Clinical Global Impression of Change (CGIC) | The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treat effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measures the proportion of responders who were rated markedly or moderately improved at Week 15 compared to Baseline. | Change from Baseline to Week 15 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Murray Raskind, MD | Department of Veterans Affairs Puget Sound Health Care System | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System | Seattle | Washington | 98108 | United States | ||
| Madigan Army Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23846759 | Result | Raskind MA, Peterson K, Williams T, Hoff DJ, Hart K, Holmes H, Homas D, Hill J, Daniels C, Calohan J, Millard SP, Rohde K, O'Connell J, Pritzl D, Feiszli K, Petrie EC, Gross C, Mayer CL, Freed MC, Engel C, Peskind ER. A trial of prazosin for combat trauma PTSD with nightmares in active-duty soldiers returned from Iraq and Afghanistan. Am J Psychiatry. 2013 Sep;170(9):1003-10. doi: 10.1176/appi.ajp.2013.12081133. | |
| 27320368 | Derived | Raskind MA, Millard SP, Petrie EC, Peterson K, Williams T, Hoff DJ, Hart K, Holmes H, Hill J, Daniels C, Hendrickson R, Peskind ER. Higher Pretreatment Blood Pressure Is Associated With Greater Posttraumatic Stress Disorder Symptom Reduction in Soldiers Treated With Prazosin. Biol Psychiatry. 2016 Nov 15;80(10):736-742. doi: 10.1016/j.biopsych.2016.03.2108. Epub 2016 Apr 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prazosin Hydrochloride | prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually. |
| FG001 | Placebo | placebo: placebo titrated in the same manner as prazosin arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prazosin Hydrochloride | prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item | Item B-2 "recurrent distressing dreams of the event" is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 15. | Of the 67 subjects randomized, 46 completed the full 15 weeks (23 per group). The outcome data reports only those 46 participants who completed the full 15 weeks. | Posted | Mean | Standard Error | Scores on a Scale | Baseline to Week 15 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prazosin Hydrochloride | prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment | One participant hospitalized for suicidal ideation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| syncope | General disorders | Non-systematic Assessment |
The sample was restricted to soldiers with frequent recalled combat trauma nightmares. More studies in civilian trauma PTSD are needed. Results cannot be extrapolated to persons with PTSD who do not recall trauma nightmares.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Murray Raskind, MD | VA Puget Sound Health Care System | 206-277-3797 | Murray.Raskind@va.gov |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003130 | Combat Disorders |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011224 | Prazosin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| placebo | Drug | placebo |
|
|
| Tacoma |
| Washington |
| 98431 |
| United States |
| Withdrawal by Subject |
|
| opted for open label prazosin |
|
| relocation/deployment |
|
| started exclusionary medication |
|
| planned major surgery |
|
| scheduling conflicts |
|
| BG001 | Placebo | placebo: placebo titrated in the same manner as prazosin arm. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | placebo: placebo titrated in the same manner as prazosin arm. |
|
|
| Primary | Change in Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 15. | Posted | Mean | Standard Error | Scores on a Scale | Baseline to Week 15 |
|
|
|
| Primary | Clinical Global Impression of Change (CGIC) | The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treat effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measures the proportion of responders who were rated markedly or moderately improved at Week 15 compared to Baseline. | Of the 67 subjects randomized, 46 completed the full 15 weeks (23 per group). The outcome data reports only those 46 participants who completed the full 15 weeks. | Posted | Number | 95% Confidence Interval | Percentage of responders | Change from Baseline to Week 15 |
|
|
|
| 0 |
| 32 |
| 18 |
| 32 |
| EG001 | Placebo | placebo: placebo titrated in the same manner as prazosin arm. | 2 | 35 | 25 | 35 |
|
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment | One participant took a nonlethal overdose of oxycodone/acetaminophen as a suicide attempt. |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| lack of energy | General disorders | Non-systematic Assessment |
|
| palpitations | Cardiac disorders | Non-systematic Assessment |
|
| drowsiness | General disorders | Non-systematic Assessment |
|
| depression | Psychiatric disorders | Non-systematic Assessment |
|
| muscle weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| headache | General disorders | Non-systematic Assessment |
|
| dizziness | General disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| other | General disorders | Non-systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002241 | Carbohydrates |