Cooperative Studies Program #563 - Prazosin and Combat Tr... | NCT00532493

NCT00532493

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

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.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prazosin Group	Active Comparator	Subjects randomized to this arm will be on prazosin.	Drug: prazosin
Placebo Group	Placebo Comparator	Subjects randomized to this arm will be on placebo.	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
prazosin	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CAPS Recurrent Distressing Dreams Item	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.	This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.
Pittsburgh Sleep Quality Index (PSQI)	Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.	This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.
Clinical Global Impression of Change (CGIC)	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.	This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.

Secondary Outcomes

Measure	Description	Time Frame
Pittsburgh Sleep Quality Index	Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.	This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).
CAPS Recurrent Distressing Dreams Item

Eligibility Module

Eligibility Criteria

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/Locations Module

Name	Affiliation	Role
Murray A. Raskind, MD	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
VA Medical Center, Loma Linda		Loma Linda	California	92357	United States
VA Medical Center, Long Beach

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29414272	Result	Raskind MA, Peskind ER, Chow B, Harris C, Davis-Karim A, Holmes HA, Hart KL, McFall M, Mellman TA, Reist C, Romesser J, Rosenheck R, Shih MC, Stein MB, Swift R, Gleason T, Lu Y, Huang GD. Trial of Prazosin for Post-Traumatic Stress Disorder in Military Veterans. N Engl J Med. 2018 Feb 8;378(6):507-517. doi: 10.1056/NEJMoa1507598.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Prazosin Group	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

PTSD clinicians ascertain interest and eligibility among their patients with nightmare. Informed consent obtained; screening assessments to determine eligibility

Arm/Group Information

ID	Title	Description
BG000	Prazosin Group	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.
BG001	Placebo Group	Subjects randomized to this arm will be on placebo. placebo: "sugar" pill
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000152 BG001152 BG002304

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00052.3± 13.8 BG00151.4± 13.8 BG00251.8± 13.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0006 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0011 BG002

Highest Educational Level

Number

participants

Title

Denominators

Categories

Grade School or Less

Title	Measurements
	BG0000 BG0010 BG002

Marital Status

Number

participants

Title

Denominators

Categories

Single

Title	Measurements
	BG00017 BG00120 BG002

Major Depression

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00051 BG00164 BG002

Maintained on any Antidepressant

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG000119 BG001117 BG002

Maintained on Selective Serotonin Re-uptake Inhibitors (SSRI)

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG000113 BG001113 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

CAPS Recurrent Distressing Dreams Item

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.

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

Posted

Mean

Standard Deviation

scores on a scale

This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.

ID	Title	Description
OG000	Prazosin Group	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.
OG001	Placebo Group	Subjects randomized to this arm will be on placebo. placebo: "sugar" pill

Units	Counts
Participants	OG000135 OG001136

Title

Denominators

Categories

Title	Measurements
	OG000-1.9± 2.1 OG001-1.7± 2.3

Primary

Pittsburgh Sleep Quality Index (PSQI)

Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.

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

Posted

Mean

Standard Deviation

scores on a scale

This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.

ID	Title	Description
OG000	Prazosin	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.
OG001	Placebo	Subjects randomized to this arm will be on placebo. placebo: "sugar" pill

Secondary

Pittsburgh Sleep Quality Index

Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.

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

Posted

Mean

Standard Deviation

scores on a scale

This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

ID	Title	Description
OG000	Prazosin	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.
OG001	Placebo	Subjects randomized to this arm will be on placebo. placebo: "sugar" pill

Secondary

CAPS Recurrent Distressing Dreams Item

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

Posted

Mean

Standard Deviation

scores on a scale

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.

ID	Title	Description
OG000	Prazosin Group	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.
OG001	Placebo Group

Secondary

Clinical Global Impression of Change

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.

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

Posted

Mean

Standard Deviation

scores on a scale

This secondary outcome measure was administered at 6, 10, 14, 18, 22 and 26 weeks (or early termination).

ID	Title	Description
OG000	Prazosin	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.
OG001	Placebo

Secondary

Total CAPS Score

Change from baseline in possible range for CAPS total score is 0-136. Higher score indicates more severe PTSD symptoms.

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

Posted

Mean

Standard Deviation

scores on a scale

The total CAPS was administered at baseline, 6, 10, 18, and 26 weeks (or early termination).

ID	Title	Description
OG000	Prazosin	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.
OG001	Placebo	Subjects randomized to this arm will be on placebo. placebo: "sugar" pill

Primary

Clinical Global Impression of Change (CGIC)

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.

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

Posted

Mean

Standard Deviation

scores on a scale

This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.

ID	Title	Description
OG000	Prazosin	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.
OG001	Placebo

Secondary

PTSD Checklist-Military Version (PCL-M) Score

Change from baseline in possible range for PCL-M score 17-85. Higher PCL score indicates greater propensity for chronic and delayed PTSD.

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

Posted

Mean

Standard Deviation

scores on a scale

This secondary outcome was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks to assess change in PTSD symptom severity.

ID	Title	Description
OG000	Prazosin	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.
OG001	Placebo	Subjects randomized to this arm will be on placebo. placebo: "sugar" pill

Secondary

Patient Health Questionnaire-9 (PHQ9)

Change from baseline in possible range for PHQ9 score is 0-27. Higher PHQ9 score indicates more severe depression.

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

Posted

Mean

Standard Deviation

scores on a scale

This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

ID	Title	Description
OG000	Prazosin	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.
OG001	Placebo	Subjects randomized to this arm will be on placebo. placebo: "sugar" pill

Secondary

SF-12 Physical Standardized Score (SF-12 PCS)

Change from baseline in possible range for SF-12 PCS is 6-72. Higher SF-12 score indicates better level of health.

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

Posted

Mean

Standard Deviation

scores on a scale

This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

ID	Title	Description
OG000	Prazosin	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.
OG001	Placebo	Subjects randomized to this arm will be on placebo. placebo: "sugar" pill

Secondary

SF-12 Mental Standardized Score (SF-12 MCS)

Change from baseline in possible range for SF-12 MCS is 5-76. Higher SF-12 score indicates better level of health.

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

Posted

Mean

Standard Deviation

scores on a scale

This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

ID	Title	Description
OG000	Prazosin	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.
OG001	Placebo	Subjects randomized to this arm will be on placebo. placebo: "sugar" pill

Secondary

Quality of Life Inventory (QOLI)

Change from baseline in possible range for QOLI is -6 to 6. Higher QOLI indicates better satisfaction with life.

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

Posted

Mean

Standard Deviation

scores on a scale

This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

ID	Title	Description
OG000	Prazosin	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.
OG001	Placebo	Subjects randomized to this arm will be on placebo. placebo: "sugar" pill

Secondary

Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)

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.

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

Posted

Mean

Standard Deviation

scores on a scale

This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

ID	Title	Description
OG000	Prazosin	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.
OG001	Placebo

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Prazosin Group	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.			18	152	142	152
EG001	Placebo Group	Subjects randomized to this arm will be on placebo. placebo: "sugar" pill			17	152	139	152

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Coronary artery disease	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Arteriovenous malformation	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Retinal detachment	Eye disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Abdominal hernia	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Small intestinal obstruction	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Chest pain	General disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Drug withdrawal syndrome	General disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Campylobacter infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Cellulitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Ankle fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Arthropod sting	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Delayed recovery from anaesthesia	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Endotracheal intubation complication	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Fall	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Road traffic accident	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Fracture malunion	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Basal ganglia infarction	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Sudden onset of sleep	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Alcoholic psychosis	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Depression	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Substance abuse	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Suicidal ideation	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0012 events2 affected152 at risk
Violence-related symptom	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Hip arthroplasty	Surgical and medical procedures	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Microcytic anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Arrhythmia	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Coronary artery disease	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0013 events1 affected152 at risk
Myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Palpitations	Cardiac disorders	Non-systematic Assessment	EG00037 events32 affected152 at risk EG00127 events24 affected152 at risk
Tachycardia	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Arteriovenous malformation	Congenital, familial and genetic disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Deafness	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Ear discomfort	Ear and labyrinth disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0012 events2 affected152 at risk
Ear pain	Ear and labyrinth disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected152 at risk
Motion sickness	Ear and labyrinth disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Tinnitus	Ear and labyrinth disorders	Non-systematic Assessment	EG0003 events3 affected152 at risk EG0012 events2 affected152 at risk
Vertigo positional	Ear and labyrinth disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Abnormal sensation in eye	Eye disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Dry eye	Eye disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Eye pruritus	Eye disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0012 events2 affected152 at risk
Lacrimation increased	Eye disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Presbyopia	Eye disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Retinal detachment	Eye disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Vision blurred	Eye disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Visual acuity reduced	Eye disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Abdominal discomfort	Gastrointestinal disorders	Non-systematic Assessment	EG0006 events4 affected152 at risk EG0011 events1 affected152 at risk
Abdominal hernia	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Abdominal pain	Gastrointestinal disorders	Non-systematic Assessment	EG0003 events2 affected152 at risk EG0010 events0 affected152 at risk
Abdominal pain lower	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Abdominal pain upper	Gastrointestinal disorders	Non-systematic Assessment	EG0003 events3 affected152 at risk EG0011 events1 affected152 at risk
Aphthous stomatitis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Colitis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG0003 events2 affected152 at risk EG0011 events1 affected152 at risk
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG0009 events9 affected152 at risk EG0019 events9 affected152 at risk
Dry mouth	Gastrointestinal disorders	Non-systematic Assessment	EG0006 events6 affected152 at risk EG00111 events11 affected152 at risk
Dyspepsia	Gastrointestinal disorders	Non-systematic Assessment	EG0004 events4 affected152 at risk EG0017 events6 affected152 at risk
Flatulence	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Food poisoning	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0012 events1 affected152 at risk
Gastritis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0013 events3 affected152 at risk
Glossodynia	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Haematochezia	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Haemorrhoids	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG00061 events47 affected152 at risk EG00156 events41 affected152 at risk
Peptic ulcer	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Small intestinal obstruction	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Toothache	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0007 events5 affected152 at risk EG0017 events7 affected152 at risk
Adverse drug reaction	General disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Asthenia	General disorders	Non-systematic Assessment	EG00093 events55 affected152 at risk EG00192 events64 affected152 at risk
Atrophy	General disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Chest pain	General disorders	Non-systematic Assessment	EG0004 events4 affected152 at risk EG0016 events6 affected152 at risk
Chills	General disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Drug ineffective	General disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Drug withdrawal syndrome	General disorders	Non-systematic Assessment	EG0004 events1 affected152 at risk EG0010 events0 affected152 at risk
Feeling abnormal	General disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0012 events2 affected152 at risk
Feeling jittery	General disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Gait disturbance	General disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Irritability	General disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected152 at risk
Medical device complication	General disorders	Non-systematic Assessment	EG0002 events1 affected152 at risk EG0010 events0 affected152 at risk
Non-cardiac chest pain	General disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Oedema	General disorders	Non-systematic Assessment	EG00017 events14 affected152 at risk EG00114 events11 affected152 at risk
Oedema peripheral	General disorders	Non-systematic Assessment	EG0006 events6 affected152 at risk EG0016 events5 affected152 at risk
Pain	General disorders	Non-systematic Assessment	EG0003 events3 affected152 at risk EG0012 events2 affected152 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0013 events3 affected152 at risk
Swelling	General disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected152 at risk
Thirst	General disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected152 at risk
Unevaluable event	General disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Cholelithiasis	Hepatobiliary disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Hepatic steatosis	Hepatobiliary disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Food allergy	Immune system disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Multiple allergies	Immune system disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Seasonal allergy	Immune system disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Acarodermatitis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Bronchitis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0012 events2 affected152 at risk
Campylobacter infection	Infections and infestations	Non-systematic Assessment	EG0005 events1 affected152 at risk EG0010 events0 affected152 at risk
Cellulitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Ear infection	Infections and infestations	Non-systematic Assessment	EG0003 events3 affected152 at risk EG0011 events1 affected152 at risk
Enteritis infectious	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Fungal infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Furuncle	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Gastroenteritis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Herpes zoster	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Influenza	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0013 events3 affected152 at risk
Lyme disease	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG0006 events5 affected152 at risk EG0012 events2 affected152 at risk
Parotitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0012 events2 affected152 at risk
Respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0002 events1 affected152 at risk EG0010 events0 affected152 at risk
Sinusitis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0012 events2 affected152 at risk
Subcutaneous abscess	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Tooth abscess	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Tooth infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0004 events4 affected152 at risk EG0011 events1 affected152 at risk
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Viral infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Accident at home	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Animal bite	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0012 events2 affected152 at risk
Ankle fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Arthropod bite	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Arthropod sting	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Bite	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Cardiac procedure complication	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Chest injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Corneal abrasion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Delayed recovery from anaesthesia	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Endotracheal intubation complication	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Eye injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Fall	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0004 events4 affected152 at risk EG0013 events3 affected152 at risk
Head injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Laceration	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Limb injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Muscle strain	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0012 events1 affected152 at risk
Poisoning	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Radius fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Rib fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Road traffic accident	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0011 events1 affected152 at risk
Tendon injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Tooth injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Wrist fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Blood glucose increased	Investigations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Blood thyroid stimulating hormone increased	Investigations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Colonoscopy	Investigations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Electrocardiogram abnormal	Investigations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Endoscopy	Investigations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Glycosylated haemoglobin increased	Investigations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Helicobacter test positive	Investigations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Sputum culture positive	Investigations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Weight increased	Investigations	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected152 at risk
White blood cell count increased	Investigations	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Decreased appetite	Metabolism and nutrition disorders	Non-systematic Assessment	EG0004 events4 affected152 at risk EG0010 events0 affected152 at risk
Dehydration	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected152 at risk
Gout	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Hyponatraemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Increased appetite	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0013 events3 affected152 at risk
Back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0006 events5 affected152 at risk EG0015 events5 affected152 at risk
Flank pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0011 events1 affected152 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0006 events3 affected152 at risk EG0012 events2 affected152 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0003 events3 affected152 at risk EG0014 events4 affected152 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected152 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected152 at risk
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Amnesia	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Basal ganglia infarction	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Disturbance in attention	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Dizziness	Nervous system disorders	Non-systematic Assessment	EG000107 events73 affected152 at risk EG001106 events63 affected152 at risk
Dizziness postural	Nervous system disorders	Non-systematic Assessment	EG00061 events52 affected152 at risk EG00147 events40 affected152 at risk
Drooling	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Head discomfort	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG00071 events54 affected152 at risk EG00178 events65 affected152 at risk
Hypoaesthesia	Nervous system disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected152 at risk
Lethargy	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Memory impairment	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Migraine	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Paraesthesia	Nervous system disorders	Non-systematic Assessment	EG0003 events2 affected152 at risk EG0010 events0 affected152 at risk
Periodic limb movement disorder	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Restless legs syndrome	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Sedation	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Somnolence	Nervous system disorders	Non-systematic Assessment	EG00064 events51 affected152 at risk EG00161 events48 affected152 at risk
Sudden onset of sleep	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Syncope	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Tremor	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
VIIth nerve paralysis	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Aggression	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Alcoholic psychosis	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Anger	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Anxiety	Psychiatric disorders	Non-systematic Assessment	EG0003 events3 affected152 at risk EG0013 events3 affected152 at risk
Bruxism	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Confusional state	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Dependence	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Depressed mood	Psychiatric disorders	Non-systematic Assessment	EG00034 events26 affected152 at risk EG00144 events38 affected152 at risk
Depression	Psychiatric disorders	Non-systematic Assessment	EG00017 events14 affected152 at risk EG00111 events10 affected152 at risk
Flashback	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Hallucination	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Insomnia	Psychiatric disorders	Non-systematic Assessment	EG00037 events33 affected152 at risk EG00140 events36 affected152 at risk
Libido decreased	Psychiatric disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected152 at risk
Nightmare	Psychiatric disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0012 events2 affected152 at risk
Panic attack	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Somnambulism	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Stress	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Substance abuse	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Suicidal ideation	Psychiatric disorders	Non-systematic Assessment	EG00014 events12 affected152 at risk EG00127 events23 affected152 at risk
Violence-related symptom	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Dysuria	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Haematuria	Renal and urinary disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected152 at risk
Incontinence	Renal and urinary disorders	Non-systematic Assessment	EG00013 events12 affected152 at risk EG0016 events6 affected152 at risk
Micturition urgency	Renal and urinary disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Nephrolithiasis	Renal and urinary disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0011 events1 affected152 at risk
Nocturia	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0012 events2 affected152 at risk
Pollakiuria	Renal and urinary disorders	Non-systematic Assessment	EG00039 events33 affected152 at risk EG00134 events30 affected152 at risk
Stress urinary incontinence	Renal and urinary disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Urinary incontinence	Renal and urinary disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected152 at risk
Epididymitis	Reproductive system and breast disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Erection increased	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Gynaecomastia	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Priapism	Reproductive system and breast disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0007 events7 affected152 at risk EG0019 events6 affected152 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0007 events7 affected152 at risk EG0012 events2 affected152 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0013 events3 affected152 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG00071 events57 affected152 at risk EG00154 events49 affected152 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0005 events5 affected152 at risk EG0012 events2 affected152 at risk
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events1 affected152 at risk EG0010 events0 affected152 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0012 events2 affected152 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 events3 affected152 at risk EG0010 events0 affected152 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0012 events2 affected152 at risk
Dermatitis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Eczema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0012 events1 affected152 at risk
Erythema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Pruritus	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0014 events4 affected152 at risk
Psoriasis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected152 at risk EG0014 events4 affected152 at risk
Skin lesion	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Skin odour abnormal	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Substance use	Social circumstances	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Chondroplasty	Surgical and medical procedures	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Endodontic procedure	Surgical and medical procedures	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Hip arthroplasty	Surgical and medical procedures	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Nerve block	Surgical and medical procedures	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Polypectomy	Surgical and medical procedures	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Surgery	Surgical and medical procedures	Non-systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Flushing	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Hypertension	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Hypotension	Vascular disorders	Non-systematic Assessment	EG0007 events7 affected152 at risk EG0013 events2 affected152 at risk
Orthostatic hypotension	Vascular disorders	Non-systematic Assessment	EG00014 events10 affected152 at risk EG0017 events4 affected152 at risk
Hot flush	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk

ID	Term
D013313	Stress Disorders, Post-Traumatic
D012893	Sleep Wake Disorders
D020447	Parasomnias

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D011224	Prazosin

Units	Counts
Participants	OG000135 OG001136

Units	Counts
Participants	OG000141 OG001143

Subjects randomized to this arm will be on placebo.

placebo: "sugar" pill

Subjects randomized to this arm will be on placebo.

placebo: "sugar" pill

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds