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Trial record 36 of 2244 for:    Symptoms | Parasomnias

Cooperative Studies Program #563 - Prazosin and Combat Trauma PTSD (PACT)

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ClinicalTrials.gov Identifier: NCT00532493
Recruitment Status : Completed
First Posted : September 20, 2007
Results First Posted : June 18, 2014
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions PTSD
Sleep Disorders
Interventions Drug: prazosin
Other: placebo
Enrollment 304
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prazosin Group Placebo Group
Hide 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
Reason Not Completed
Death             1             1
Lost to Follow-up             10             7
Withdrawal by Subject             7             9
Physician Decision             1             6
Adverse Event             6             5
Protocol Deviation             1             0
Subject Moved Away             3             1
Contraindicative Medication             1             0
Arm/Group Title Prazosin Group Placebo Group Total
Hide 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 Number of Baseline Participants 152 152 304
Hide Baseline Analysis Population Description
PTSD clinicians ascertain interest and eligibility among their patients with nightmare. Informed consent obtained; screening assessments to determine eligibility
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 152 participants 152 participants 304 participants
52.3  (13.8) 51.4  (13.8) 51.8  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
Female
6
   3.9%
1
   0.7%
7
   2.3%
Male
146
  96.1%
151
  99.3%
297
  97.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
American Indian or Alaska Native
2
   1.3%
1
   0.7%
3
   1.0%
Asian
3
   2.0%
1
   0.7%
4
   1.3%
Native Hawaiian or Other Pacific Islander
1
   0.7%
0
   0.0%
1
   0.3%
Black or African American
38
  25.0%
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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
Grade School or Less 0 0 0
Some High School 5 5 10
High School/GED 35 29 64
Some College/Ass.Degree/Tech.School 79 77 156
College Graduate 22 25 47
Post Graduate/Professional Degree 7 13 20
Other 2 1 3
Did Not Answer 2 2 4
Marital Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
Single 17 20 37
Married 82 89 171
Living Together in a Relationship 3 4 7
Separated 6 6 12
Divorced 39 27 66
Widowed 3 4 7
Did Not Answer 2 2 4
Major Depression  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
Yes 51 64 115
No 101 88 189
Maintained on any Antidepressant  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
Yes 119 117 236
No 33 35 68
Maintained on Selective Serotonin Re-uptake Inhibitors (SSRI)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
Yes 113 113 226
No 39 39 78
1.Primary Outcome
Title CAPS Recurrent Distressing Dreams Item
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 135 136
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.9  (2.1) -1.7  (2.3)
2.Primary Outcome
Title Pittsburgh Sleep Quality Index (PSQI)
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 135 136
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-2.3  (4.2) -2.1  (4)
3.Primary Outcome
Title Clinical Global Impression of Change (CGIC)
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 135 136
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.3  (1.4) 3.3  (1.4)
4.Secondary Outcome
Title Pittsburgh Sleep Quality Index
Hide 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 141 143
Mean (Standard Deviation)
Unit of Measure: scores on a scale
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)
5.Secondary Outcome
Title CAPS Recurrent Distressing Dreams Item
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 141 143
Mean (Standard Deviation)
Unit of Measure: scores on a scale
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)
6.Secondary Outcome
Title Clinical Global Impression of Change
Hide 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 141 143
Mean (Standard Deviation)
Unit of Measure: scores on a scale
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)
7.Secondary Outcome
Title Total CAPS Score
Hide 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 141 143
Mean (Standard Deviation)
Unit of Measure: scores on a scale
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)
8.Secondary Outcome
Title PTSD Checklist-Military Version (PCL-M) Score
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 141 143
Mean (Standard Deviation)
Unit of Measure: scores on a scale
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)
9.Secondary Outcome
Title Patient Health Questionnaire-9 (PHQ9)
Hide 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 141 143
Mean (Standard Deviation)
Unit of Measure: scores on a scale
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)
10.Secondary Outcome
Title SF-12 Physical Standardized Score (SF-12 PCS)
Hide 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 141 143
Mean (Standard Deviation)
Unit of Measure: scores on a scale
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)
11.Secondary Outcome
Title SF-12 Mental Standardized Score (SF-12 MCS)
Hide 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 141 143
Mean (Standard Deviation)
Unit of Measure: scores on a scale
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)
12.Secondary Outcome
Title Quality of Life Inventory (QOLI)
Hide 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 141 143
Mean (Standard Deviation)
Unit of Measure: scores on a scale
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)
13.Secondary Outcome
Title Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Hide 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).
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Hide 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
Hide 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

Overall Number of Participants Analyzed 141 143
Mean (Standard Deviation)
Unit of Measure: scores on a scale
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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prazosin Group Placebo Group
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Prazosin Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/152 (11.84%)      17/152 (11.18%)    
Blood and lymphatic system disorders     
Anaemia *  0/152 (0.00%)  0 1/152 (0.66%)  1
Cardiac disorders     
Coronary artery disease *  0/152 (0.00%)  0 1/152 (0.66%)  1
Myocardial infarction *  1/152 (0.66%)  1 0/152 (0.00%)  0
Arteriovenous malformation *  0/152 (0.00%)  0 1/152 (0.66%)  1
Eye disorders     
Retinal detachment *  0/152 (0.00%)  0 1/152 (0.66%)  1
Gastrointestinal disorders     
Abdominal hernia *  0/152 (0.00%)  0 1/152 (0.66%)  1
Haemorrhagic erosive gastritis *  0/152 (0.00%)  0 1/152 (0.66%)  1
Small intestinal obstruction *  1/152 (0.66%)  1 0/152 (0.00%)  0
General disorders     
Chest pain *  1/152 (0.66%)  1 0/152 (0.00%)  0
Drug withdrawal syndrome *  1/152 (0.66%)  1 0/152 (0.00%)  0
Infections and infestations     
Campylobacter infection *  1/152 (0.66%)  1 0/152 (0.00%)  0
Cellulitis *  0/152 (0.00%)  0 1/152 (0.66%)  1
Pneumonia *  1/152 (0.66%)  1 1/152 (0.66%)  1
Injury, poisoning and procedural complications     
Ankle fracture *  1/152 (0.66%)  1 0/152 (0.00%)  0
Arthropod sting *  0/152 (0.00%)  0 1/152 (0.66%)  1
Delayed recovery from anaesthesia *  1/152 (0.66%)  1 0/152 (0.00%)  0
Endotracheal intubation complication *  1/152 (0.66%)  1 0/152 (0.00%)  0
Fall *  1/152 (0.66%)  1 1/152 (0.66%)  1
Road traffic accident *  1/152 (0.66%)  1 1/152 (0.66%)  1
Toxicity to various agents *  1/152 (0.66%)  1 1/152 (0.66%)  1
Musculoskeletal and connective tissue disorders     
Fracture malunion *  1/152 (0.66%)  1 0/152 (0.00%)  0
Musculoskeletal chest pain *  0/152 (0.00%)  0 1/152 (0.66%)  1
Nervous system disorders     
Basal ganglia infarction *  0/152 (0.00%)  0 1/152 (0.66%)  1
Sudden onset of sleep *  1/152 (0.66%)  1 0/152 (0.00%)  0
Psychiatric disorders     
Alcoholic psychosis *  1/152 (0.66%)  1 0/152 (0.00%)  0
Depression *  1/152 (0.66%)  1 0/152 (0.00%)  0
Substance abuse *  1/152 (0.66%)  1 1/152 (0.66%)  1
Suicidal ideation *  0/152 (0.00%)  0 2/152 (1.32%)  2
Violence-related symptom *  1/152 (0.66%)  1 1/152 (0.66%)  1
Surgical and medical procedures     
Hip arthroplasty *  1/152 (0.66%)  1 0/152 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prazosin Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   142/152 (93.42%)      139/152 (91.45%)    
Blood and lymphatic system disorders     
Anaemia *  0/152 (0.00%)  0 1/152 (0.66%)  1
Microcytic anaemia *  1/152 (0.66%)  1 0/152 (0.00%)  0
Cardiac disorders     
Arrhythmia *  1/152 (0.66%)  1 0/152 (0.00%)  0
Atrial fibrillation *  1/152 (0.66%)  1 0/152 (0.00%)  0
Coronary artery disease *  0/152 (0.00%)  0 1/152 (0.66%)  3
Myocardial infarction *  1/152 (0.66%)  1 0/152 (0.00%)  0
Palpitations *  32/152 (21.05%)  37 24/152 (15.79%)  27
Tachycardia *  1/152 (0.66%)  1 0/152 (0.00%)  0
Congenital, familial and genetic disorders     
Arteriovenous malformation *  0/152 (0.00%)  0 1/152 (0.66%)  1
Ear and labyrinth disorders     
Deafness *  0/152 (0.00%)  0 1/152 (0.66%)  1
Ear discomfort *  1/152 (0.66%)  1 2/152 (1.32%)  2
Ear pain *  2/152 (1.32%)  2 0/152 (0.00%)  0
Motion sickness *  1/152 (0.66%)  1 1/152 (0.66%)  1
Tinnitus *  3/152 (1.97%)  3 2/152 (1.32%)  2
Vertigo positional *  1/152 (0.66%)  1 0/152 (0.00%)  0
Eye disorders     
Abnormal sensation in eye *  1/152 (0.66%)  1 1/152 (0.66%)  1
Dry eye *  0/152 (0.00%)  0 1/152 (0.66%)  1
Eye pruritus *  1/152 (0.66%)  1 2/152 (1.32%)  2
Lacrimation increased *  0/152 (0.00%)  0 1/152 (0.66%)  1
Presbyopia *  0/152 (0.00%)  0 1/152 (0.66%)  1
Retinal detachment *  0/152 (0.00%)  0 1/152 (0.66%)  1
Vision blurred *  1/152 (0.66%)  1 0/152 (0.00%)  0
Visual acuity reduced *  1/152 (0.66%)  1 0/152 (0.00%)  0
Gastrointestinal disorders     
Abdominal discomfort *  4/152 (2.63%)  6 1/152 (0.66%)  1
Abdominal hernia *  0/152 (0.00%)  0 1/152 (0.66%)  1
Abdominal pain *  2/152 (1.32%)  3 0/152 (0.00%)  0
Abdominal pain lower *  1/152 (0.66%)  1 0/152 (0.00%)  0
Abdominal pain upper *  3/152 (1.97%)  3 1/152 (0.66%)  1
Aphthous stomatitis *  1/152 (0.66%)  1 0/152 (0.00%)  0
Colitis *  0/152 (0.00%)  0 1/152 (0.66%)  1
Constipation *  2/152 (1.32%)  3 1/152 (0.66%)  1
Diarrhoea *  9/152 (5.92%)  9 9/152 (5.92%)  9
Dry mouth *  6/152 (3.95%)  6 11/152 (7.24%)  11
Dyspepsia *  4/152 (2.63%)  4 6/152 (3.95%)  7
Flatulence *  1/152 (0.66%)  1 1/152 (0.66%)  1
Food poisoning *  2/152 (1.32%)  2 1/152 (0.66%)  2
Gastritis *  1/152 (0.66%)  1 1/152 (0.66%)  1
Gastrooesophageal reflux disease *  0/152 (0.00%)  0 3/152 (1.97%)  3
Glossodynia *  1/152 (0.66%)  1 0/152 (0.00%)  0
Haematochezia *  0/152 (0.00%)  0 1/152 (0.66%)  1
Haemorrhagic erosive gastritis *  0/152 (0.00%)  0 1/152 (0.66%)  1
Haemorrhoids *  0/152 (0.00%)  0 1/152 (0.66%)  1
Nausea *  47/152 (30.92%)  61 41/152 (26.97%)  56
Peptic ulcer *  1/152 (0.66%)  1 0/152 (0.00%)  0
Small intestinal obstruction *  1/152 (0.66%)  1 0/152 (0.00%)  0
Toothache *  1/152 (0.66%)  1 0/152 (0.00%)  0
Vomiting *  5/152 (3.29%)  7 7/152 (4.61%)  7
General disorders     
Adverse drug reaction *  0/152 (0.00%)  0 1/152 (0.66%)  1
Asthenia *  55/152 (36.18%)  93 64/152 (42.11%)  92
Atrophy *  0/152 (0.00%)  0 1/152 (0.66%)  1
Chest pain *  4/152 (2.63%)  4 6/152 (3.95%)  6
Chills *  0/152 (0.00%)  0 1/152 (0.66%)  1
Drug ineffective *  0/152 (0.00%)  0 1/152 (0.66%)  1
Drug withdrawal syndrome *  1/152 (0.66%)  4 0/152 (0.00%)  0
Feeling abnormal *  0/152 (0.00%)  0 2/152 (1.32%)  2
Feeling jittery *  0/152 (0.00%)  0 1/152 (0.66%)  1
Gait disturbance *  1/152 (0.66%)  1 1/152 (0.66%)  1
Irritability *  2/152 (1.32%)  2 0/152 (0.00%)  0
Medical device complication *  1/152 (0.66%)  2 0/152 (0.00%)  0
Non-cardiac chest pain *  0/152 (0.00%)  0 1/152 (0.66%)  1
Oedema *  14/152 (9.21%)  17 11/152 (7.24%)  14
Oedema peripheral *  6/152 (3.95%)  6 5/152 (3.29%)  6
Pain *  3/152 (1.97%)  3 2/152 (1.32%)  2
Pyrexia *  2/152 (1.32%)  2 3/152 (1.97%)  3
Swelling *  2/152 (1.32%)  2 0/152 (0.00%)  0
Thirst *  2/152 (1.32%)  2 0/152 (0.00%)  0
Unevaluable event *  0/152 (0.00%)  0 1/152 (0.66%)  1
Hepatobiliary disorders     
Cholelithiasis *  1/152 (0.66%)  1 1/152 (0.66%)  1
Hepatic steatosis *  1/152 (0.66%)  1 0/152 (0.00%)  0
Immune system disorders     
Food allergy *  0/152 (0.00%)  0 1/152 (0.66%)  1
Multiple allergies *  0/152 (0.00%)  0 1/152 (0.66%)  1
Seasonal allergy *  0/152 (0.00%)  0 1/152 (0.66%)  1
Infections and infestations     
Acarodermatitis *  1/152 (0.66%)  1 0/152 (0.00%)  0
Bronchitis *  2/152 (1.32%)  2 2/152 (1.32%)  2
Campylobacter infection *  1/152 (0.66%)  5 0/152 (0.00%)  0
Cellulitis *  0/152 (0.00%)  0 1/152 (0.66%)  1
Ear infection *  3/152 (1.97%)  3 1/152 (0.66%)  1
Enteritis infectious *  1/152 (0.66%)  1 0/152 (0.00%)  0
Fungal infection *  0/152 (0.00%)  0 1/152 (0.66%)  1
Furuncle *  1/152 (0.66%)  1 0/152 (0.00%)  0
Gastroenteritis *  1/152 (0.66%)  1 0/152 (0.00%)  0
Herpes zoster *  0/152 (0.00%)  0 1/152 (0.66%)  1
Influenza *  2/152 (1.32%)  2 3/152 (1.97%)  3
Lyme disease *  1/152 (0.66%)  1 0/152 (0.00%)  0
Nasopharyngitis *  5/152 (3.29%)  6 2/152 (1.32%)  2
Parotitis *  0/152 (0.00%)  0 1/152 (0.66%)  1
Pneumonia *  2/152 (1.32%)  2 2/152 (1.32%)  2
Respiratory tract infection *  1/152 (0.66%)  2 0/152 (0.00%)  0
Sinusitis *  2/152 (1.32%)  2 2/152 (1.32%)  2
Subcutaneous abscess *  0/152 (0.00%)  0 1/152 (0.66%)  1
Tooth abscess *  1/152 (0.66%)  1 0/152 (0.00%)  0
Tooth infection *  1/152 (0.66%)  1 0/152 (0.00%)  0
Upper respiratory tract infection *  4/152 (2.63%)  4 1/152 (0.66%)  1
Urinary tract infection *  1/152 (0.66%)  1 0/152 (0.00%)  0
Viral infection *  1/152 (0.66%)  1 0/152 (0.00%)  0
Injury, poisoning and procedural complications     
Accident at home *  1/152 (0.66%)  1 0/152 (0.00%)  0
Animal bite *  1/152 (0.66%)  1 2/152 (1.32%)  2
Ankle fracture *  1/152 (0.66%)  1 0/152 (0.00%)  0
Arthropod bite *  1/152 (0.66%)  1 0/152 (0.00%)  0
Arthropod sting *  1/152 (0.66%)  1 1/152 (0.66%)  1
Bite *  1/152 (0.66%)  1 0/152 (0.00%)  0
Cardiac procedure complication *  1/152 (0.66%)  1 0/152 (0.00%)  0
Chest injury *  0/152 (0.00%)  0 1/152 (0.66%)  1
Corneal abrasion *  1/152 (0.66%)  1 0/152 (0.00%)  0
Delayed recovery from anaesthesia *  1/152 (0.66%)  1 0/152 (0.00%)  0
Endotracheal intubation complication *  1/152 (0.66%)  1 0/152 (0.00%)  0
Eye injury *  0/152 (0.00%)  0 1/152 (0.66%)  1
Fall *  4/152 (2.63%)  4 3/152 (1.97%)  3
Head injury *  0/152 (0.00%)  0 1/152 (0.66%)  1
Laceration *  1/152 (0.66%)  1 0/152 (0.00%)  0
Limb injury *  0/152 (0.00%)  0 1/152 (0.66%)  1
Muscle strain *  0/152 (0.00%)  0 1/152 (0.66%)  2
Poisoning *  1/152 (0.66%)  1 0/152 (0.00%)  0
Radius fracture *  0/152 (0.00%)  0 1/152 (0.66%)  1
Rib fracture *  1/152 (0.66%)  1 0/152 (0.00%)  0
Road traffic accident *  2/152 (1.32%)  2 1/152 (0.66%)  1
Tendon injury *  1/152 (0.66%)  1 0/152 (0.00%)  0
Tooth injury *  1/152 (0.66%)  1 0/152 (0.00%)  0
Toxicity to various agents *  1/152 (0.66%)  1 1/152 (0.66%)  1
Wrist fracture *  0/152 (0.00%)  0 1/152 (0.66%)  1
Investigations     
Blood glucose increased *  1/152 (0.66%)  1 0/152 (0.00%)  0
Blood thyroid stimulating hormone increased *  1/152 (0.66%)  1 0/152 (0.00%)  0
Colonoscopy *  1/152 (0.66%)  1 1/152 (0.66%)  1
Electrocardiogram abnormal *  1/152 (0.66%)  1 1/152 (0.66%)  1
Endoscopy *  1/152 (0.66%)  1 0/152 (0.00%)  0
Glycosylated haemoglobin increased *  1/152 (0.66%)  1 0/152 (0.00%)  0
Helicobacter test positive *  1/152 (0.66%)  1 0/152 (0.00%)  0
Sputum culture positive *  1/152 (0.66%)  1 0/152 (0.00%)  0
Weight increased *  2/152 (1.32%)  2 0/152 (0.00%)  0
White blood cell count increased *  1/152 (0.66%)  1 0/152 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite *  4/152 (2.63%)  4 0/152 (0.00%)  0
Dehydration *  2/152 (1.32%)  2 0/152 (0.00%)  0
Gout *  1/152 (0.66%)  1 1/152 (0.66%)  1
Hyponatraemia *  1/152 (0.66%)  1 0/152 (0.00%)  0
Increased appetite *  0/152 (0.00%)  0 1/152 (0.66%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia *  2/152 (1.32%)  2 3/152 (1.97%)  3
Back pain *  5/152 (3.29%)  6 5/152 (3.29%)  5
Flank pain *  2/152 (1.32%)  2 1/152 (0.66%)  1
Intervertebral disc degeneration *  0/152 (0.00%)  0 1/152 (0.66%)  1
Muscle spasms *  3/152 (1.97%)  6 2/152 (1.32%)  2
Muscular weakness *  3/152 (1.97%)  3 4/152 (2.63%)  4
Musculoskeletal chest pain *  1/152 (0.66%)  1 1/152 (0.66%)  1
Musculoskeletal pain *  1/152 (0.66%)  1 0/152 (0.00%)  0
Musculoskeletal stiffness *  2/152 (1.32%)  2 0/152 (0.00%)  0
Myalgia *  1/152 (0.66%)  1 1/152 (0.66%)  1
Osteoporosis *  0/152 (0.00%)  0 1/152 (0.66%)  1
Pain in extremity *  2/152 (1.32%)  2 0/152 (0.00%)  0
Tenosynovitis stenosans *  0/152 (0.00%)  0 1/152 (0.66%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma *  1/152 (0.66%)  1 0/152 (0.00%)  0
Lipoma *  1/152 (0.66%)  1 0/152 (0.00%)  0
Melanocytic naevus *  1/152 (0.66%)  1 0/152 (0.00%)  0
Neuroma *  1/152 (0.66%)  1 0/152 (0.00%)  0
Squamous cell carcinoma of skin *  1/152 (0.66%)  1 0/152 (0.00%)  0
Nervous system disorders     
Amnesia *  0/152 (0.00%)  0 1/152 (0.66%)  1
Basal ganglia infarction *  0/152 (0.00%)  0 1/152 (0.66%)  1
Disturbance in attention *  1/152 (0.66%)  1 0/152 (0.00%)  0
Dizziness *  73/152 (48.03%)  107 63/152 (41.45%)  106
Dizziness postural *  52/152 (34.21%)  61 40/152 (26.32%)  47
Drooling *  1/152 (0.66%)  1 0/152 (0.00%)  0
Head discomfort *  1/152 (0.66%)  1 1/152 (0.66%)  1
Headache *  54/152 (35.53%)  71 65/152 (42.76%)  78
Hypoaesthesia *  2/152 (1.32%)  2 0/152 (0.00%)  0
Lethargy *  0/152 (0.00%)  0 1/152 (0.66%)  1
Memory impairment *  1/152 (0.66%)  1 1/152 (0.66%)  1
Migraine *  1/152 (0.66%)  1 1/152 (0.66%)  1
Paraesthesia *  2/152 (1.32%)  3 0/152 (0.00%)  0
Periodic limb movement disorder *  1/152 (0.66%)  1 0/152 (0.00%)  0
Restless legs syndrome *  1/152 (0.66%)  1 0/152 (0.00%)  0
Sedation *  0/152 (0.00%)  0 1/152 (0.66%)  1
Somnolence *  51/152 (33.55%)  64 48/152 (31.58%)  61
Sudden onset of sleep *  1/152 (0.66%)  1 0/152 (0.00%)  0
Syncope *  1/152 (0.66%)  1 0/152 (0.00%)  0
Tremor *  1/152 (0.66%)  1 1/152 (0.66%)  1
VIIth nerve paralysis *  0/152 (0.00%)  0 1/152 (0.66%)  1
Psychiatric disorders     
Aggression *  1/152 (0.66%)  1 0/152 (0.00%)  0
Alcoholic psychosis *  1/152 (0.66%)  1 0/152 (0.00%)  0
Anger *  0/152 (0.00%)  0 1/152 (0.66%)  1
Anxiety *  3/152 (1.97%)  3 3/152 (1.97%)  3
Bruxism *  1/152 (0.66%)  1 0/152 (0.00%)  0
Confusional state *  0/152 (0.00%)  0 1/152 (0.66%)  1
Dependence *  0/152 (0.00%)  0 1/152 (0.66%)  1
Depressed mood *  26/152 (17.11%)  34 38/152 (25.00%)  44
Depression *  14/152 (9.21%)  17 10/152 (6.58%)  11
Flashback *  1/152 (0.66%)  1 0/152 (0.00%)  0
Hallucination *  0/152 (0.00%)  0 1/152 (0.66%)  1
Insomnia *  33/152 (21.71%)  37 36/152 (23.68%)  40
Libido decreased *  2/152 (1.32%)  2 0/152 (0.00%)  0
Nightmare *  2/152 (1.32%)  2 2/152 (1.32%)  2
Panic attack *  0/152 (0.00%)  0 1/152 (0.66%)  1
Somnambulism *  0/152 (0.00%)  0 1/152 (0.66%)  1
Stress *  0/152 (0.00%)  0 1/152 (0.66%)  1
Substance abuse *  1/152 (0.66%)  1 1/152 (0.66%)  1
Suicidal ideation *  12/152 (7.89%)  14 23/152 (15.13%)  27
Violence-related symptom *  1/152 (0.66%)  1 1/152 (0.66%)  1
Renal and urinary disorders     
Dysuria *  0/152 (0.00%)  0 1/152 (0.66%)  1
Haematuria *  2/152 (1.32%)  2 0/152 (0.00%)  0
Incontinence *  12/152 (7.89%)  13 6/152 (3.95%)  6
Micturition urgency *  1/152 (0.66%)  1 0/152 (0.00%)  0
Nephrolithiasis *  2/152 (1.32%)  2 1/152 (0.66%)  1
Nocturia *  0/152 (0.00%)  0 2/152 (1.32%)  2
Pollakiuria *  33/152 (21.71%)  39 30/152 (19.74%)  34
Stress urinary incontinence *  1/152 (0.66%)  1 0/152 (0.00%)  0
Urinary incontinence *  2/152 (1.32%)  2 0/152 (0.00%)  0
Reproductive system and breast disorders     
Epididymitis *  1/152 (0.66%)  1 0/152 (0.00%)  0
Erection increased *  0/152 (0.00%)  0 1/152 (0.66%)  1
Gynaecomastia *  0/152 (0.00%)  0 1/152 (0.66%)  1
Priapism *  1/152 (0.66%)  1 1/152 (0.66%)  1
Respiratory, thoracic and mediastinal disorders     
Cough *  7/152 (4.61%)  7 6/152 (3.95%)  9
Dyspnoea *  7/152 (4.61%)  7 2/152 (1.32%)  2
Epistaxis *  1/152 (0.66%)  1 3/152 (1.97%)  3
Nasal congestion *  57/152 (37.50%)  71 49/152 (32.24%)  54
Oropharyngeal pain *  5/152 (3.29%)  5 2/152 (1.32%)  2
Pharyngeal oedema *  0/152 (0.00%)  0 1/152 (0.66%)  1
Pleuritic pain *  0/152 (0.00%)  0 1/152 (0.66%)  1
Productive cough *  1/152 (0.66%)  2 0/152 (0.00%)  0
Pulmonary congestion *  1/152 (0.66%)  1 1/152 (0.66%)  1
Rhinorrhoea *  0/152 (0.00%)  0 2/152 (1.32%)  2
Sinus congestion *  0/152 (0.00%)  0 1/152 (0.66%)  1
Sleep apnoea syndrome *  3/152 (1.97%)  3 0/152 (0.00%)  0
Sneezing *  1/152 (0.66%)  1 2/152 (1.32%)  2
Skin and subcutaneous tissue disorders     
Dermatitis *  1/152 (0.66%)  1 0/152 (0.00%)  0
Dermatitis allergic *  1/152 (0.66%)  1 0/152 (0.00%)  0
Eczema *  0/152 (0.00%)  0 1/152 (0.66%)  2
Erythema *  0/152 (0.00%)  0 1/152 (0.66%)  1
Hyperhidrosis *  1/152 (0.66%)  1 0/152 (0.00%)  0
Hyperkeratosis *  1/152 (0.66%)  1 0/152 (0.00%)  0
Ingrowing nail *  1/152 (0.66%)  1 0/152 (0.00%)  0
Pruritus *  1/152 (0.66%)  1 4/152 (2.63%)  4
Psoriasis *  1/152 (0.66%)  1 0/152 (0.00%)  0
Rash *  2/152 (1.32%)  2 4/152 (2.63%)  4
Skin lesion *  1/152 (0.66%)  1 1/152 (0.66%)  1
Skin odour abnormal *  0/152 (0.00%)  0 1/152 (0.66%)  1
Skin ulcer *  1/152 (0.66%)  1 0/152 (0.00%)  0
Social circumstances     
Substance use *  1/152 (0.66%)  1 0/152 (0.00%)  0
Surgical and medical procedures     
Chondroplasty *  1/152 (0.66%)  1 0/152 (0.00%)  0
Endodontic procedure *  0/152 (0.00%)  0 1/152 (0.66%)  1
Hip arthroplasty *  1/152 (0.66%)  1 0/152 (0.00%)  0
Nerve block *  1/152 (0.66%)  1 0/152 (0.00%)  0
Polypectomy *  0/152 (0.00%)  0 1/152 (0.66%)  1
Surgery *  1/152 (0.66%)  1 1/152 (0.66%)  1
Vascular disorders     
Flushing *  0/152 (0.00%)  0 1/152 (0.66%)  1
Hypertension *  0/152 (0.00%)  0 1/152 (0.66%)  1
Hypotension *  7/152 (4.61%)  7 2/152 (1.32%)  3
Orthostatic hypotension *  10/152 (6.58%)  14 4/152 (2.63%)  7
Hot flush *  0/152 (0.00%)  0 1/152 (0.66%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Dr. Murray Rasknd
Organization: VA Puget Sound Health Care System
Phone: (206) 764-2702
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00532493     History of Changes
Other Study ID Numbers: 563
First Submitted: September 18, 2007
First Posted: September 20, 2007
Results First Submitted: April 2, 2014
Results First Posted: June 18, 2014
Last Update Posted: May 1, 2018