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

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ClinicalTrials.gov Identifier: NCT00990106
Recruitment Status : Completed
First Posted : October 6, 2009
Results First Posted : September 1, 2014
Last Update Posted : May 23, 2018
Sponsor:
Collaborators:
United States Department of Defense
VA Puget Sound Health Care System
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research

October 2, 2009
October 6, 2009
April 16, 2014
September 1, 2014
May 23, 2018
September 2009
March 2013   (Final data collection date for primary outcome measure)
  • Change in Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item [ Time Frame: Baseline to Week 15 ]
    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) [ Time Frame: Baseline to Week 15 ]
    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) [ Time Frame: Change from Baseline to Week 15 ]
    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.
  • Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item [ Time Frame: Baseline, Weeks 7, 11 and 15 ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, Weeks 7, 11 and 15 ]
  • Clinical Global Impression of Change CGIC) [ Time Frame: Weeks 7, 11 and 15 ]
Complete list of historical versions of study NCT00990106 on ClinicalTrials.gov Archive Site
Not Provided
  • Clinician-Administered PTSD Scale (CAPS) Total Score [ Time Frame: Baseline, Weeks 7, 11 and 15 ]
  • CAPS Symptom Clusters (Reexperiencing/Intrusions, Numbing/Avoidance, and Hyperarousal) [ Time Frame: Baseline, Weeks 7, 11 and 15 ]
  • Hamilton Depression Scale (HAM-D) [ Time Frame: Baseline, Weeks 7, 11 and 15 ]
  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline, Weeks 7, 11 and 15 ]
  • Quality Of Life Inventory (QOLI) [ Time Frame: Baseline, Weeks 7, 11 and 15 ]
  • SF-12V [ Time Frame: Baseline, Weeks 7, 11 and 15 ]
  • Penn Alcohol Craving Scale (PACS) [ Time Frame: Baseline, Weeks 7, 11 and 15 ]
  • Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) [ Time Frame: Baseline, Weeks 7, 11 and 15 ]
Not Provided
Not Provided
 
Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)
A Placebo-Controlled Augmentation Trial of Prazosin for PTSD

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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Stress Disorders, Post-Traumatic
  • Combat Disorders
  • Sleep Disorders
  • Drug: prazosin hydrochloride
    Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually.
    Other Names:
    • prazosin
    • Pfizer Minipress
  • Drug: placebo
    placebo
    Other Name: sugar pill
  • Active Comparator: prazosin hydrochloride

    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.

    Intervention: Drug: prazosin hydrochloride
  • Placebo Comparator: placebo

    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: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
210
March 2013
March 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00990106
PT074250
1P20AA017839-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Seattle Institute for Biomedical and Clinical Research
Seattle Institute for Biomedical and Clinical Research
  • United States Department of Defense
  • VA Puget Sound Health Care System
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study Chair: Murray Raskind, MD Department of Veterans Affairs Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP