PACT: Cooperative Studies Program #563 - Prazosin and Combat Trauma PTSD
Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00532493
Collaborator
(none)
304
15
2
40.8
20.3
0.5
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
304 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
CSP #563 - Prazosin and Combat Trauma PTSD (PACT)
Actual Study Start Date
:
Jan 6, 2010
Actual Primary Completion Date
:
Feb 28, 2013
Actual Study Completion Date
:
May 31, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Prazosin Group Subjects randomized to this arm will be on prazosin. |
Drug: prazosin
Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
| Placebo Comparator: Placebo Group Subjects randomized to this arm will be on placebo. |
Other: placebo
"sugar" pill
|
Outcome Measures
Primary Outcome Measures
- CAPS Recurrent Distressing Dreams Item [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.
- Pittsburgh Sleep Quality Index (PSQI) [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.
- Clinical Global Impression of Change (CGIC) [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.
Secondary Outcome Measures
- Pittsburgh Sleep Quality Index [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.
- CAPS Recurrent Distressing Dreams Item [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.
- Clinical Global Impression of Change [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.
- Total CAPS Score [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.
- PTSD Checklist-Military Version (PCL-M) Score [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.
- Patient Health Questionnaire-9 (PHQ9) [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.
- SF-12 Physical Standardized Score (SF-12 PCS) [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.
- SF-12 Mental Standardized Score (SF-12 MCS) [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.
- Quality of Life Inventory (QOLI) [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.
- Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) [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 Audit-C score is 0-12. Higher score indicates heavier use of alcohol. A score of >=4 for male and a score of >=3 for female meets the criteria for alcohol use disorders.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Age >18 years.
-
Exposure to one or more life-threatening war zone trauma events per the Combat
-
Exposure Scale [78] and documented by Department of Defense (DD) Form 214, Combat Action Ribbon (Marines), Combat Infantry Badge (Army), or other clear evidence of war zone trauma exposure.
-
Eligible for VA health care.
-
Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnosis of PTSD derived from the CAPS.
-
CAPS total score >50.
-
CAPS Recurrent Distressing Dreams item score >5 (of maximum score of 8).
-
Capable of giving informed consent.
-
Stable dose of non-exclusionary (see below) medications for at least 4 weeks prior to randomization.
-
Psychotherapeutic treatment stable for at least 4 weeks prior to randomization.
-
Good general medical health (see Medical Exclusion Criteria below).
-
Female participants must agree to use a reliable form of birth control during the study.
Exclusion Criteria:
Medical:
-
Acute or unstable chronic medical illness, including unstable angina, recent myocardial infarction (within 6 months), congestive heart failure, preexisting hypotension (systolic <110) or orthostatic hypotension (systolic drop > 20 millimeters of mercury after two minutes standing or any drop accompanied by dizziness); chronic renal or hepatic failure, pancreatitis, Meniere's disease, benign positional vertigo; narcolepsy.
-
Untreated sleep apnea, diagnosed by a sleep study, is exclusionary. Treated sleep apnea (e.g., Continuous Positive Airway Pressure, surgery) will not be exclusionary.
-
Allergy or previous adverse reaction to prazosin or other alpha-1 antagonist.
-
Wounds requiring surgery, embedded shrapnel, and recent surgical amputation do not comprise an exclusion if the individual is otherwise medically eligible.
-
Women of childbearing potential with positive pregnancy test or refusal to use effective birth control method, or who are breastfeeding will be excluded.
Psychiatric/Behavioral:
-
Meets DSM-IV criteria for current schizophrenia, schizoaffective disorder, psychotic disorder not otherwise specified (NOS), delirium, or any DSM-IV cognitive disorder.
-
Exclusion for psychotic disorder is not to be confused with combat trauma-induced reexperiencing symptoms (transient dissociative states or flashbacks), which will not be exclusionary.
-
Substance dependence disorder within 3 months or any current substance dependence (stable methadone maintenance will not be exclusionary).
-
Current cocaine or stimulant abuse.
-
Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others.
-
Nonsuicidal depression comorbid with PTSD will not be exclusionary (see below).
Medications/Therapies:
-
Current use of prazosin or other alpha-1 antagonist.
-
Previous adequate trial of prazosin for PTSD.
-
Subjects on trazodone will undergo a 2-week washout period before baseline assessment. (Combining prazosin and trazodone may increase risk of priapism).
-
Sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra) will be not be permitted during the study dose titration period because of increased risk of hypotension in combination with alpha-1 blockers. Following achieving stable dose of study drug, sildenafil, tadalafil, and vardenafil will be permitted at 1/2 the usual starting dose.
-
Stimulants or alternative medications with stimulant properties (e.g., ephedra).
-
Recent exposure therapy and/or Eye Movement Desensitization and Reprogramming (EMDR). These therapies must have been completed > 4 weeks before randomization.
-
Other psychotropic medications and/or maintenance psychotherapy at a stable dose for at least 4 weeks will not be exclusionary.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Medical Center, Loma Linda | Loma Linda | California | United States | 92357 |
| 2 | VA Medical Center, Long Beach | Long Beach | California | United States | 90822 |
| 3 | VA Palo Alto Health Care System | Palo Alto | California | United States | 94304-1290 |
| 4 | VA Medical Center, Miami | Miami | Florida | United States | 33125 |
| 5 | Atlanta VA Medical and Rehab Center, Decatur | Decatur | Georgia | United States | 30033 |
| 6 | VA Medical Center, Kansas City MO | Kansas City | Missouri | United States | 64128 |
| 7 | New Mexico VA Health Care System, Albuquerque | Albuquerque | New Mexico | United States | 87108-5153 |
| 8 | New York Harbor HCS | New York | New York | United States | 10010 |
| 9 | VA Medical Center, Durham | Durham | North Carolina | United States | 27705 |
| 10 | Salisbury VAMC | Salisbury | North Carolina | United States | 28144 |
| 11 | VA Medical Center, Providence | Providence | Rhode Island | United States | 02908 |
| 12 | WJB Dorn Veterans Hospital, Columbia | Columbia | South Carolina | United States | 29209 |
| 13 | VA Salt Lake City Health Care System, Salt Lake City | Salt Lake City | Utah | United States | 84148 |
| 14 | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | United States | 98108 |
| 15 | Wlliam S. Middleton Memorial Veterans Hospital, Madison | Madison | Wisconsin | United States | 53705 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Study Chair: Murray A. Raskind, MD, VA Puget Sound Health Care System Seattle Division, Seattle, WA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00532493
Other Study ID Numbers:
- 563
First Posted:
Sep 20, 2007
Last Update Posted:
May 1, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Prazosin Group | Placebo Group |
|---|---|---|
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill |
| Period Title: Overall Study | ||
| STARTED | 152 | 152 |
| COMPLETED | 122 | 123 |
| NOT COMPLETED | 30 | 29 |
Baseline Characteristics
| Arm/Group Title | Prazosin Group | Placebo Group | Total |
|---|---|---|---|
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill | Total of all reporting groups |
| Overall Participants | 152 | 152 | 304 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
52.3
(13.8)
|
51.4
(13.8)
|
51.8
(13.8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
6
3.9%
|
1
0.7%
|
7
2.3%
|
| Male |
146
96.1%
|
151
99.3%
|
297
97.7%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
2
1.3%
|
1
0.7%
|
3
1%
|
| Asian |
3
2%
|
1
0.7%
|
4
1.3%
|
| Native Hawaiian or Other Pacific Islander |
1
0.7%
|
0
0%
|
1
0.3%
|
| Black or African American |
38
25%
|
37
24.3%
|
75
24.7%
|
| White |
91
59.9%
|
101
66.4%
|
192
63.2%
|
| More than one race |
9
5.9%
|
4
2.6%
|
13
4.3%
|
| Unknown or Not Reported |
8
5.3%
|
8
5.3%
|
16
5.3%
|
| Highest Educational Level (participants) [Number] | |||
| Grade School or Less |
0
0%
|
0
0%
|
0
0%
|
| Some High School |
5
3.3%
|
5
3.3%
|
10
3.3%
|
| High School/GED |
35
23%
|
29
19.1%
|
64
21.1%
|
| Some College/Ass.Degree/Tech.School |
79
52%
|
77
50.7%
|
156
51.3%
|
| College Graduate |
22
14.5%
|
25
16.4%
|
47
15.5%
|
| Post Graduate/Professional Degree |
7
4.6%
|
13
8.6%
|
20
6.6%
|
| Other |
2
1.3%
|
1
0.7%
|
3
1%
|
| Did Not Answer |
2
1.3%
|
2
1.3%
|
4
1.3%
|
| Marital Status (participants) [Number] | |||
| Single |
17
11.2%
|
20
13.2%
|
37
12.2%
|
| Married |
82
53.9%
|
89
58.6%
|
171
56.3%
|
| Living Together in a Relationship |
3
2%
|
4
2.6%
|
7
2.3%
|
| Separated |
6
3.9%
|
6
3.9%
|
12
3.9%
|
| Divorced |
39
25.7%
|
27
17.8%
|
66
21.7%
|
| Widowed |
3
2%
|
4
2.6%
|
7
2.3%
|
| Did Not Answer |
2
1.3%
|
2
1.3%
|
4
1.3%
|
| Major Depression (participants) [Number] | |||
| Yes |
51
33.6%
|
64
42.1%
|
115
37.8%
|
| No |
101
66.4%
|
88
57.9%
|
189
62.2%
|
| Maintained on any Antidepressant (participants) [Number] | |||
| Yes |
119
78.3%
|
117
77%
|
236
77.6%
|
| No |
33
21.7%
|
35
23%
|
68
22.4%
|
| Maintained on Selective Serotonin Re-uptake Inhibitors (SSRI) (participants) [Number] | |||
| Yes |
113
74.3%
|
113
74.3%
|
226
74.3%
|
| No |
39
25.7%
|
39
25.7%
|
78
25.7%
|
Outcome Measures
| Title | CAPS Recurrent Distressing Dreams Item |
|---|---|
| Description | 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. |
| Time Frame | This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10 |
| Arm/Group Title | Prazosin Group | Placebo Group |
|---|---|---|
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill |
| Measure Participants | 135 | 136 |
| Mean (Standard Deviation) [scores on a scale] |
-1.9
(2.1)
|
-1.7
(2.3)
|
| Title | Pittsburgh Sleep Quality Index (PSQI) |
|---|---|
| Description | Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep. |
| Time Frame | This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10 |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill |
| Measure Participants | 135 | 136 |
| Mean (Standard Deviation) [scores on a scale] |
-2.3
(4.2)
|
-2.1
(4)
|
| Title | Pittsburgh Sleep Quality Index |
|---|---|
| Description | Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep. |
| Time Frame | This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination). |
Outcome Measure Data
| Analysis Population Description |
|---|
| 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill |
| Measure Participants | 141 | 143 |
| Baseline |
14.4
(3.3)
|
14.7
(3.5)
|
| Change at Week 6 |
-2.1
(3.9)
|
-2.4
(4.2)
|
| Change at Week 10 |
-2.3
(4.2)
|
-2.1
(4)
|
| Change at Week 14 |
-3.1
(3.9)
|
-2.7
(3.9)
|
| Change at Week 18 |
-2.4
(4.1)
|
-2.8
(4)
|
| Change at Week 22 |
-2.9
(4)
|
-2.7
(4.2)
|
| Change at Week 26 |
-2.9
(4.3)
|
-2.7
(4.1)
|
| Title | CAPS Recurrent Distressing Dreams Item |
|---|---|
| Description | 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. |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks |
| Arm/Group Title | Prazosin Group | Placebo Group |
|---|---|---|
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill |
| Measure Participants | 141 | 143 |
| Baseline |
6.3
(0.9)
|
6.3
(0.9)
|
| Change at Week 6 |
-1.3
(1.8)
|
-1.4
(1.8)
|
| Change at Week 10 |
-1.9
(2.1)
|
-1.7
(2.3)
|
| Change at Week 14 |
-2.2
(2.2)
|
-2.5
(2.5)
|
| Change at Week 18 |
-1.8
(2.3)
|
-2.4
(2.5)
|
| Change at Week 22 |
-2.4
(2.3)
|
-2.5
(2.4)
|
| Change at Week 26 |
-2.3
(2.5)
|
-2.2
(2.5)
|
| Title | Clinical Global Impression of Change |
|---|---|
| Description | 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. |
| Time Frame | This secondary outcome measure was administered at 6, 10, 14, 18, 22 and 26 weeks (or early termination). |
Outcome Measure Data
| Analysis Population Description |
|---|
| 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill |
| Measure Participants | 141 | 143 |
| Week 6 |
3.2
(1.2)
|
3.3
(1.3)
|
| Week 10 |
3.3
(1.4)
|
3.3
(1.4)
|
| Week 14 |
3
(1.4)
|
3
(1.4)
|
| Week 18 |
3.2
(1.3)
|
3
(1.4)
|
| Week 22 |
2.9
(1.4)
|
2.9
(1.3)
|
| Week 26 |
2.9
(1.6)
|
2.9
(1.4)
|
| Title | Total CAPS Score |
|---|---|
| Description | Change from baseline in possible range for CAPS total score is 0-136. Higher score indicates more severe PTSD symptoms. |
| Time Frame | The total CAPS was administered at baseline, 6, 10, 18, and 26 weeks (or early termination). |
Outcome Measure Data
| Analysis Population Description |
|---|
| 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill |
| Measure Participants | 141 | 143 |
| Baseline |
80.7
(15.5)
|
81.9
(17.1)
|
| Change at Week 6 |
-9.9
(16)
|
-9.1
(16.9)
|
| Change at Week 10 |
-11.4
(17.2)
|
-12.1
(19.4)
|
| Change at Week 18 |
-11.6
(18.3)
|
-17.2
(21.7)
|
| Change at Week 26 |
-14.1
(21.8)
|
-16.2
(24.2)
|
| Title | Clinical Global Impression of Change (CGIC) |
|---|---|
| Description | 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. |
| Time Frame | This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10 |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill |
| Measure Participants | 135 | 136 |
| Mean (Standard Deviation) [scores on a scale] |
3.3
(1.4)
|
3.3
(1.4)
|
| Title | PTSD Checklist-Military Version (PCL-M) Score |
|---|---|
| Description | Change from baseline in possible range for PCL-M score 17-85. Higher PCL score indicates greater propensity for chronic and delayed PTSD. |
| Time Frame | This secondary outcome was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks to assess change in PTSD symptom severity. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill |
| Measure Participants | 141 | 143 |
| Baseline |
62.5
(11.1)
|
64.3
(12.2)
|
| Change at Week 6 |
-6.3
(10.6)
|
-6.2
(11)
|
| Change at Week 10 |
-7
(12.7)
|
-5.8
(11.6)
|
| Change at Week 14 |
-8.1
(12.5)
|
-7.6
(11.6)
|
| Change at Week 18 |
-7.2
(12.3)
|
-8.4
(13.3)
|
| Change at Week 22 |
-7.1
(12.9)
|
-9.2
(13.5)
|
| Change at Week 26 |
-8.2
(13.8)
|
-9.7
(14)
|
| Title | Patient Health Questionnaire-9 (PHQ9) |
|---|---|
| Description | Change from baseline in possible range for PHQ9 score is 0-27. Higher PHQ9 score indicates more severe depression. |
| Time Frame | This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination). |
Outcome Measure Data
| Analysis Population Description |
|---|
| 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill |
| Measure Participants | 141 | 143 |
| Baseline |
13.7
(5.9)
|
14.6
(5.9)
|
| Change at Week 6 |
-1.6
(4.7)
|
-2.8
(5.1)
|
| Change at Week 10 |
-1.9
(5.1)
|
-2.2
(5.1)
|
| Change at Week 14 |
-1.9
(5.2)
|
-2.6
(5.3)
|
| Change at Week 18 |
-1.6
(5.3)
|
-2.4
(5.5)
|
| Change at Week 22 |
-2.2
(5.6)
|
-2.5
(5.9)
|
| Change at Week 26 |
-2
(5.5)
|
-2.8
(5.8)
|
| Title | SF-12 Physical Standardized Score (SF-12 PCS) |
|---|---|
| Description | Change from baseline in possible range for SF-12 PCS is 6-72. Higher SF-12 score indicates better level of health. |
| Time Frame | This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination). |
Outcome Measure Data
| Analysis Population Description |
|---|
| 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill |
| Measure Participants | 141 | 143 |
| Baseline |
35.4
(14.5)
|
34.2
(12.2)
|
| Change at Week 6 |
1.8
(9.7)
|
0.8
(10.2)
|
| Change at Week 10 |
0.3
(10)
|
0.3
(10.4)
|
| Change at Week 14 |
1.4
(10.1)
|
0.3
(10.9)
|
| Change at Week 18 |
0.5
(10)
|
-0.4
(11.4)
|
| Change at Week 22 |
1.1
(10.9)
|
-0.8
(13.2)
|
| Change at Week 26 |
0.7
(11.8)
|
-0.2
(11.9)
|
| Title | SF-12 Mental Standardized Score (SF-12 MCS) |
|---|---|
| Description | Change from baseline in possible range for SF-12 MCS is 5-76. Higher SF-12 score indicates better level of health. |
| Time Frame | This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination). |
Outcome Measure Data
| Analysis Population Description |
|---|
| 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill |
| Measure Participants | 141 | 143 |
| Baseline |
38.2
(9.1)
|
39.4
(8.4)
|
| Change at Week 6 |
-2
(9.2)
|
-1.3
(8.5)
|
| Change at Week 10 |
-1
(9.2)
|
-1.1
(8.7)
|
| Change at Week 14 |
-1.5
(7.9)
|
-1
(9.7)
|
| Change at Week 18 |
-0.2
(8.4)
|
-0.7
(8.8)
|
| Change at Week 22 |
-0.8
(8.9)
|
-0.6
(9.4)
|
| Change at Week 26 |
-0.7
(8.7)
|
-0.8
(9.5)
|
| Title | Quality of Life Inventory (QOLI) |
|---|---|
| Description | Change from baseline in possible range for QOLI is -6 to 6. Higher QOLI indicates better satisfaction with life. |
| Time Frame | This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination). |
Outcome Measure Data
| Analysis Population Description |
|---|
| 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill |
| Measure Participants | 141 | 143 |
| Baseline |
0.1
(1.9)
|
0
(1.9)
|
| Change at Week 6 |
0.1
(1.5)
|
0
(1.4)
|
| Change at Week 10 |
0
(1.3)
|
0.1
(1.7)
|
| Change at Week 14 |
0.1
(1.5)
|
0
(1.5)
|
| Change at Week 18 |
0.3
(1.3)
|
0.1
(1.6)
|
| Change at Week 22 |
0.1
(1.4)
|
0.1
(1.9)
|
| Change at Week 26 |
0.2
(1.4)
|
0.2
(2)
|
| Title | Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) |
|---|---|
| Description | Change from baseline in possible range for Audit-C score is 0-12. Higher score indicates heavier use of alcohol. A score of >=4 for male and a score of >=3 for female meets the criteria for alcohol use disorders. |
| Time Frame | This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination). |
Outcome Measure Data
| Analysis Population Description |
|---|
| 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks |
| Arm/Group Title | Prazosin | Placebo |
|---|---|---|
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill |
| Measure Participants | 141 | 143 |
| Baseline |
2
(2.8)
|
2.2
(2.6)
|
| Change at Week 6 |
-0.3
(1.7)
|
-0.3
(1.7)
|
| Change at Week 10 |
-0.4
(1.4)
|
-0.2
(1.7)
|
| Change at Week 14 |
-0.2
(1.6)
|
-0.4
(2.2)
|
| Change at Week 18 |
-0.2
(1.5)
|
-0.1
(1.9)
|
| Change at Week 22 |
-0.2
(1.6)
|
-0.3
(2.1)
|
| Change at Week 26 |
-0.3
(1.4)
|
-0.3
(1.9)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Prazosin Group | Placebo Group | ||
| Arm/Group Description | Subjects randomized to this arm will be on prazosin. prazosin: Subjects 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. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually. | Subjects randomized to this arm will be on placebo. placebo: "sugar" pill | ||
All Cause Mortality |
||||
| Prazosin Group | Placebo Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Prazosin Group | Placebo Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 18/152 (11.8%) | 17/152 (11.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Cardiac disorders | ||||
| Coronary artery disease | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Myocardial infarction | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Arteriovenous malformation | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Eye disorders | ||||
| Retinal detachment | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal hernia | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Haemorrhagic erosive gastritis | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Small intestinal obstruction | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| General disorders | ||||
| Chest pain | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Drug withdrawal syndrome | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Infections and infestations | ||||
| Campylobacter infection | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Cellulitis | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Pneumonia | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Arthropod sting | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Delayed recovery from anaesthesia | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Endotracheal intubation complication | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Fall | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Road traffic accident | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Toxicity to various agents | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Fracture malunion | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Musculoskeletal chest pain | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Nervous system disorders | ||||
| Basal ganglia infarction | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Sudden onset of sleep | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Psychiatric disorders | ||||
| Alcoholic psychosis | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Depression | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Substance abuse | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Suicidal ideation | 0/152 (0%) | 0 | 2/152 (1.3%) | 2 |
| Violence-related symptom | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Surgical and medical procedures | ||||
| Hip arthroplasty | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Prazosin Group | Placebo Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 142/152 (93.4%) | 139/152 (91.4%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Microcytic anaemia | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Cardiac disorders | ||||
| Arrhythmia | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Atrial fibrillation | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Coronary artery disease | 0/152 (0%) | 0 | 1/152 (0.7%) | 3 |
| Myocardial infarction | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Palpitations | 32/152 (21.1%) | 37 | 24/152 (15.8%) | 27 |
| Tachycardia | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||
| Arteriovenous malformation | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Ear and labyrinth disorders | ||||
| Deafness | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Ear discomfort | 1/152 (0.7%) | 1 | 2/152 (1.3%) | 2 |
| Ear pain | 2/152 (1.3%) | 2 | 0/152 (0%) | 0 |
| Motion sickness | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Tinnitus | 3/152 (2%) | 3 | 2/152 (1.3%) | 2 |
| Vertigo positional | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Eye disorders | ||||
| Abnormal sensation in eye | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Dry eye | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Eye pruritus | 1/152 (0.7%) | 1 | 2/152 (1.3%) | 2 |
| Lacrimation increased | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Presbyopia | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Retinal detachment | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Vision blurred | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Visual acuity reduced | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal discomfort | 4/152 (2.6%) | 6 | 1/152 (0.7%) | 1 |
| Abdominal hernia | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Abdominal pain | 2/152 (1.3%) | 3 | 0/152 (0%) | 0 |
| Abdominal pain lower | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Abdominal pain upper | 3/152 (2%) | 3 | 1/152 (0.7%) | 1 |
| Aphthous stomatitis | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Colitis | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Constipation | 2/152 (1.3%) | 3 | 1/152 (0.7%) | 1 |
| Diarrhoea | 9/152 (5.9%) | 9 | 9/152 (5.9%) | 9 |
| Dry mouth | 6/152 (3.9%) | 6 | 11/152 (7.2%) | 11 |
| Dyspepsia | 4/152 (2.6%) | 4 | 6/152 (3.9%) | 7 |
| Flatulence | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Food poisoning | 2/152 (1.3%) | 2 | 1/152 (0.7%) | 2 |
| Gastritis | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Gastrooesophageal reflux disease | 0/152 (0%) | 0 | 3/152 (2%) | 3 |
| Glossodynia | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Haematochezia | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Haemorrhagic erosive gastritis | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Haemorrhoids | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Nausea | 47/152 (30.9%) | 61 | 41/152 (27%) | 56 |
| Peptic ulcer | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Small intestinal obstruction | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Toothache | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Vomiting | 5/152 (3.3%) | 7 | 7/152 (4.6%) | 7 |
| General disorders | ||||
| Adverse drug reaction | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Asthenia | 55/152 (36.2%) | 93 | 64/152 (42.1%) | 92 |
| Atrophy | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Chest pain | 4/152 (2.6%) | 4 | 6/152 (3.9%) | 6 |
| Chills | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Drug ineffective | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Drug withdrawal syndrome | 1/152 (0.7%) | 4 | 0/152 (0%) | 0 |
| Feeling abnormal | 0/152 (0%) | 0 | 2/152 (1.3%) | 2 |
| Feeling jittery | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Gait disturbance | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Irritability | 2/152 (1.3%) | 2 | 0/152 (0%) | 0 |
| Medical device complication | 1/152 (0.7%) | 2 | 0/152 (0%) | 0 |
| Non-cardiac chest pain | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Oedema | 14/152 (9.2%) | 17 | 11/152 (7.2%) | 14 |
| Oedema peripheral | 6/152 (3.9%) | 6 | 5/152 (3.3%) | 6 |
| Pain | 3/152 (2%) | 3 | 2/152 (1.3%) | 2 |
| Pyrexia | 2/152 (1.3%) | 2 | 3/152 (2%) | 3 |
| Swelling | 2/152 (1.3%) | 2 | 0/152 (0%) | 0 |
| Thirst | 2/152 (1.3%) | 2 | 0/152 (0%) | 0 |
| Unevaluable event | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Hepatobiliary disorders | ||||
| Cholelithiasis | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Hepatic steatosis | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Immune system disorders | ||||
| Food allergy | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Multiple allergies | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Seasonal allergy | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Infections and infestations | ||||
| Acarodermatitis | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Bronchitis | 2/152 (1.3%) | 2 | 2/152 (1.3%) | 2 |
| Campylobacter infection | 1/152 (0.7%) | 5 | 0/152 (0%) | 0 |
| Cellulitis | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Ear infection | 3/152 (2%) | 3 | 1/152 (0.7%) | 1 |
| Enteritis infectious | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Fungal infection | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Furuncle | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Gastroenteritis | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Herpes zoster | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Influenza | 2/152 (1.3%) | 2 | 3/152 (2%) | 3 |
| Lyme disease | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Nasopharyngitis | 5/152 (3.3%) | 6 | 2/152 (1.3%) | 2 |
| Parotitis | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Pneumonia | 2/152 (1.3%) | 2 | 2/152 (1.3%) | 2 |
| Respiratory tract infection | 1/152 (0.7%) | 2 | 0/152 (0%) | 0 |
| Sinusitis | 2/152 (1.3%) | 2 | 2/152 (1.3%) | 2 |
| Subcutaneous abscess | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Tooth abscess | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Tooth infection | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Upper respiratory tract infection | 4/152 (2.6%) | 4 | 1/152 (0.7%) | 1 |
| Urinary tract infection | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Viral infection | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Accident at home | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Animal bite | 1/152 (0.7%) | 1 | 2/152 (1.3%) | 2 |
| Ankle fracture | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Arthropod bite | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Arthropod sting | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Bite | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Cardiac procedure complication | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Chest injury | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Corneal abrasion | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Delayed recovery from anaesthesia | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Endotracheal intubation complication | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Eye injury | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Fall | 4/152 (2.6%) | 4 | 3/152 (2%) | 3 |
| Head injury | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Laceration | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Limb injury | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Muscle strain | 0/152 (0%) | 0 | 1/152 (0.7%) | 2 |
| Poisoning | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Radius fracture | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Rib fracture | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Road traffic accident | 2/152 (1.3%) | 2 | 1/152 (0.7%) | 1 |
| Tendon injury | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Tooth injury | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Toxicity to various agents | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Wrist fracture | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Investigations | ||||
| Blood glucose increased | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Blood thyroid stimulating hormone increased | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Colonoscopy | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Electrocardiogram abnormal | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Endoscopy | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Glycosylated haemoglobin increased | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Helicobacter test positive | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Sputum culture positive | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Weight increased | 2/152 (1.3%) | 2 | 0/152 (0%) | 0 |
| White blood cell count increased | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 4/152 (2.6%) | 4 | 0/152 (0%) | 0 |
| Dehydration | 2/152 (1.3%) | 2 | 0/152 (0%) | 0 |
| Gout | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Hyponatraemia | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Increased appetite | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 2/152 (1.3%) | 2 | 3/152 (2%) | 3 |
| Back pain | 5/152 (3.3%) | 6 | 5/152 (3.3%) | 5 |
| Flank pain | 2/152 (1.3%) | 2 | 1/152 (0.7%) | 1 |
| Intervertebral disc degeneration | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Muscle spasms | 3/152 (2%) | 6 | 2/152 (1.3%) | 2 |
| Muscular weakness | 3/152 (2%) | 3 | 4/152 (2.6%) | 4 |
| Musculoskeletal chest pain | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Musculoskeletal pain | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Musculoskeletal stiffness | 2/152 (1.3%) | 2 | 0/152 (0%) | 0 |
| Myalgia | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Osteoporosis | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Pain in extremity | 2/152 (1.3%) | 2 | 0/152 (0%) | 0 |
| Tenosynovitis stenosans | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Basal cell carcinoma | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Lipoma | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Melanocytic naevus | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Neuroma | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Squamous cell carcinoma of skin | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Nervous system disorders | ||||
| Amnesia | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Basal ganglia infarction | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Disturbance in attention | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Dizziness | 73/152 (48%) | 107 | 63/152 (41.4%) | 106 |
| Dizziness postural | 52/152 (34.2%) | 61 | 40/152 (26.3%) | 47 |
| Drooling | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Head discomfort | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Headache | 54/152 (35.5%) | 71 | 65/152 (42.8%) | 78 |
| Hypoaesthesia | 2/152 (1.3%) | 2 | 0/152 (0%) | 0 |
| Lethargy | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Memory impairment | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Migraine | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Paraesthesia | 2/152 (1.3%) | 3 | 0/152 (0%) | 0 |
| Periodic limb movement disorder | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Restless legs syndrome | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Sedation | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Somnolence | 51/152 (33.6%) | 64 | 48/152 (31.6%) | 61 |
| Sudden onset of sleep | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Syncope | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Tremor | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| VIIth nerve paralysis | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Psychiatric disorders | ||||
| Aggression | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Alcoholic psychosis | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Anger | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Anxiety | 3/152 (2%) | 3 | 3/152 (2%) | 3 |
| Bruxism | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Confusional state | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Dependence | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Depressed mood | 26/152 (17.1%) | 34 | 38/152 (25%) | 44 |
| Depression | 14/152 (9.2%) | 17 | 10/152 (6.6%) | 11 |
| Flashback | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Hallucination | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Insomnia | 33/152 (21.7%) | 37 | 36/152 (23.7%) | 40 |
| Libido decreased | 2/152 (1.3%) | 2 | 0/152 (0%) | 0 |
| Nightmare | 2/152 (1.3%) | 2 | 2/152 (1.3%) | 2 |
| Panic attack | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Somnambulism | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Stress | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Substance abuse | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Suicidal ideation | 12/152 (7.9%) | 14 | 23/152 (15.1%) | 27 |
| Violence-related symptom | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Renal and urinary disorders | ||||
| Dysuria | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Haematuria | 2/152 (1.3%) | 2 | 0/152 (0%) | 0 |
| Incontinence | 12/152 (7.9%) | 13 | 6/152 (3.9%) | 6 |
| Micturition urgency | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Nephrolithiasis | 2/152 (1.3%) | 2 | 1/152 (0.7%) | 1 |
| Nocturia | 0/152 (0%) | 0 | 2/152 (1.3%) | 2 |
| Pollakiuria | 33/152 (21.7%) | 39 | 30/152 (19.7%) | 34 |
| Stress urinary incontinence | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Urinary incontinence | 2/152 (1.3%) | 2 | 0/152 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Epididymitis | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Erection increased | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Gynaecomastia | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Priapism | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 7/152 (4.6%) | 7 | 6/152 (3.9%) | 9 |
| Dyspnoea | 7/152 (4.6%) | 7 | 2/152 (1.3%) | 2 |
| Epistaxis | 1/152 (0.7%) | 1 | 3/152 (2%) | 3 |
| Nasal congestion | 57/152 (37.5%) | 71 | 49/152 (32.2%) | 54 |
| Oropharyngeal pain | 5/152 (3.3%) | 5 | 2/152 (1.3%) | 2 |
| Pharyngeal oedema | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Pleuritic pain | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Productive cough | 1/152 (0.7%) | 2 | 0/152 (0%) | 0 |
| Pulmonary congestion | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Rhinorrhoea | 0/152 (0%) | 0 | 2/152 (1.3%) | 2 |
| Sinus congestion | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Sleep apnoea syndrome | 3/152 (2%) | 3 | 0/152 (0%) | 0 |
| Sneezing | 1/152 (0.7%) | 1 | 2/152 (1.3%) | 2 |
| Skin and subcutaneous tissue disorders | ||||
| Dermatitis | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Dermatitis allergic | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Eczema | 0/152 (0%) | 0 | 1/152 (0.7%) | 2 |
| Erythema | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Hyperhidrosis | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Hyperkeratosis | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Ingrowing nail | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Pruritus | 1/152 (0.7%) | 1 | 4/152 (2.6%) | 4 |
| Psoriasis | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Rash | 2/152 (1.3%) | 2 | 4/152 (2.6%) | 4 |
| Skin lesion | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Skin odour abnormal | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Skin ulcer | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Social circumstances | ||||
| Substance use | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Surgical and medical procedures | ||||
| Chondroplasty | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Endodontic procedure | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Hip arthroplasty | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Nerve block | 1/152 (0.7%) | 1 | 0/152 (0%) | 0 |
| Polypectomy | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Surgery | 1/152 (0.7%) | 1 | 1/152 (0.7%) | 1 |
| Vascular disorders | ||||
| Flushing | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Hypertension | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
| Hypotension | 7/152 (4.6%) | 7 | 2/152 (1.3%) | 3 |
| Orthostatic hypotension | 10/152 (6.6%) | 14 | 4/152 (2.6%) | 7 |
| Hot flush | 0/152 (0%) | 0 | 1/152 (0.7%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Dr. Murray Rasknd |
|---|---|
| Organization | VA Puget Sound Health Care System |
| Phone | (206) 764-2702 |
| Murray.Raskind@va.gov |
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00532493
Other Study ID Numbers:
- 563
First Posted:
Sep 20, 2007
Last Update Posted:
May 1, 2018
Last Verified:
Mar 1, 2018