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Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)

Primary Purpose

Stress Disorders, Post-Traumatic, Combat Disorders, Sleep Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
prazosin hydrochloride
placebo
Sponsored by
Seattle Institute for Biomedical and Clinical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring posttraumatic stress disorder, PTSD, nightmares, prazosin, sleep disturbance, combat trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Age >18 years;
  • Clear evidence of exposure to one or more war zone trauma events sufficient to satisfy DSM-IV criterion A1 for diagnosis of PTSD;
  • 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);
  • stable dose of non-exclusionary medications and psychotherapeutic treatment for at least 4 weeks prior to randomization;
  • good general medical health.
  • Female participants must agree to use a reliable form of birth control during the study.

Exclusion Criteria

  • Psychiatric/Behavioral - meets DSM-IV criteria for current schizophrenia, schizoaffective disorder, psychotic disorder, delirium, or any DSM-IV cognitive disorder; substance dependence disorder within 3 months or any current substance dependence; 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.
  • Medical - acute or unstable chronic medical illness, including unstable angina, recent myocardial infarction (within 6 months), congestive heart failure, preexisting hypotension or orthostatic hypotension, chronic renal or hepatic failure, pancreatitis, Meniere's disease, benign positional vertigo; narcolepsy, or diagnosed sleep apnea; allergy or previous adverse reaction to prazosin or other alpha-1 antagonist.

Sites / Locations

  • VA Puget Sound Health Care System
  • Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

prazosin hydrochloride

placebo

Arm Description

prazosin Pfizer Minipress oral capsules Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose.

placebo oral capsules Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose.

Outcomes

Primary Outcome Measures

Change in Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item
Item B-2 "recurrent distressing dreams of the event" is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 15.
Change in Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 15.
Clinical Global Impression of Change (CGIC)
The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treat effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measures the proportion of responders who were rated markedly or moderately improved at Week 15 compared to Baseline.

Secondary Outcome Measures

Full Information

First Posted
October 2, 2009
Last Updated
April 25, 2018
Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
United States Department of Defense, VA Puget Sound Health Care System, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00990106
Brief Title
Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)
Official Title
A Placebo-Controlled Augmentation Trial of Prazosin for PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
United States Department of Defense, VA Puget Sound Health Care System, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether prazosin will: reduce the incidence of nightmares and sleep disturbance increase functioning and sense of well being in combat-trauma exposed Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Veterans.
Detailed Description
This is a 15-week randomized parallel design, double-blind, placebo-controlled augmentation trial of prazosin to evaluate the efficacy and tolerability of prazosin augmentation in the treatment of PTSD trauma-related nightmares, sleep disturbance, global function and sense of well-being, and other clinical features and comorbidities of PTSD. Participants will be 210 OIF/OEF soldiers and veterans who have suffered war zone trauma. Participants will be randomized 1:1 to prazosin or placebo and all previous psychotropic medications and/or psychotherapy will be maintained constant. Randomization will be stratified by site and use of an antidepressant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Combat Disorders, Sleep Disorders
Keywords
posttraumatic stress disorder, PTSD, nightmares, prazosin, sleep disturbance, combat trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prazosin hydrochloride
Arm Type
Active Comparator
Arm Description
prazosin Pfizer Minipress oral capsules Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo oral capsules Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose.
Intervention Type
Drug
Intervention Name(s)
prazosin hydrochloride
Other Intervention Name(s)
prazosin, Pfizer Minipress
Intervention Description
Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
sugar pill
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Change in Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item
Description
Item B-2 "recurrent distressing dreams of the event" is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 15.
Time Frame
Baseline to Week 15
Title
Change in Pittsburgh Sleep Quality Index (PSQI)
Description
Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 15.
Time Frame
Baseline to Week 15
Title
Clinical Global Impression of Change (CGIC)
Description
The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treat effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measures the proportion of responders who were rated markedly or moderately improved at Week 15 compared to Baseline.
Time Frame
Change from Baseline to Week 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Age >18 years; Clear evidence of exposure to one or more war zone trauma events sufficient to satisfy DSM-IV criterion A1 for diagnosis of PTSD; 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); stable dose of non-exclusionary medications and psychotherapeutic treatment for at least 4 weeks prior to randomization; good general medical health. Female participants must agree to use a reliable form of birth control during the study. Exclusion Criteria Psychiatric/Behavioral - meets DSM-IV criteria for current schizophrenia, schizoaffective disorder, psychotic disorder, delirium, or any DSM-IV cognitive disorder; substance dependence disorder within 3 months or any current substance dependence; 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. Medical - acute or unstable chronic medical illness, including unstable angina, recent myocardial infarction (within 6 months), congestive heart failure, preexisting hypotension or orthostatic hypotension, chronic renal or hepatic failure, pancreatitis, Meniere's disease, benign positional vertigo; narcolepsy, or diagnosed sleep apnea; allergy or previous adverse reaction to prazosin or other alpha-1 antagonist.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murray Raskind, MD
Organizational Affiliation
Department of Veterans Affairs Puget Sound Health Care System
Official's Role
Study Chair
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23846759
Citation
Raskind MA, Peterson K, Williams T, Hoff DJ, Hart K, Holmes H, Homas D, Hill J, Daniels C, Calohan J, Millard SP, Rohde K, O'Connell J, Pritzl D, Feiszli K, Petrie EC, Gross C, Mayer CL, Freed MC, Engel C, Peskind ER. A trial of prazosin for combat trauma PTSD with nightmares in active-duty soldiers returned from Iraq and Afghanistan. Am J Psychiatry. 2013 Sep;170(9):1003-10. doi: 10.1176/appi.ajp.2013.12081133.
Results Reference
result
PubMed Identifier
27320368
Citation
Raskind MA, Millard SP, Petrie EC, Peterson K, Williams T, Hoff DJ, Hart K, Holmes H, Hill J, Daniels C, Hendrickson R, Peskind ER. Higher Pretreatment Blood Pressure Is Associated With Greater Posttraumatic Stress Disorder Symptom Reduction in Soldiers Treated With Prazosin. Biol Psychiatry. 2016 Nov 15;80(10):736-742. doi: 10.1016/j.biopsych.2016.03.2108. Epub 2016 Apr 11.
Results Reference
derived

Learn more about this trial

Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)

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