Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)
This study is ongoing, but not recruiting participants.
Sponsor:
Seattle Institute for Biomedical and Clinical Research
Collaborators:
VA Puget Sound Health Care System
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:
NCT00990106
First received: October 2, 2009
Last updated: February 25, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Stress Disorders, Post-Traumatic Combat Disorders Sleep Disorders |
Drug: prazosin hydrochloride Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Placebo-Controlled Augmentation Trial of Prazosin for PTSD |
Resource links provided by NLM:
Further study details as provided by Seattle Institute for Biomedical and Clinical Research:
Primary Outcome Measures:
- Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item [ Time Frame: Baseline, Weeks 7, 11 and 15 ] [ Designated as safety issue: No ]
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, Weeks 7, 11 and 15 ] [ Designated as safety issue: No ]
- Clinical Global Impression of Change (CGIC) [ Time Frame: Weeks 7, 11 and 15 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinician-Administered PTSD Scale (CAPS) Total Score [ Time Frame: Baseline, Weeks 7, 11 and 15 ] [ Designated as safety issue: No ]
- CAPS symptom clusters (Reexperiencing/Intrusions, Numbing/Avoidance, and Hyperarousal) [ Time Frame: Baseline, Weeks 7, 11 and 15 ] [ Designated as safety issue: No ]
- Hamilton Depression Scale (HAM-D) [ Time Frame: Baseline, Weeks 7, 11 and 15 ] [ Designated as safety issue: No ]
- Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline, Weeks 7, 11 and 15 ] [ Designated as safety issue: No ]
- Quality Of Life Inventory (QOLI) [ Time Frame: Baseline, Weeks 7, 11 and 15 ] [ Designated as safety issue: No ]
- SF-12V [ Time Frame: Baseline, Weeks 7, 11 and 15 ] [ Designated as safety issue: No ]
- Penn Alcohol Craving Scale (PACS) [ Time Frame: Baseline, Weeks 7, 11 and 15 ] [ Designated as safety issue: No ]
- Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) [ Time Frame: Baseline, Weeks 7, 11 and 15 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: prazosin hydrochloride |
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:
|
| Placebo Comparator: placebo |
Drug: placebo
placebo
Other Name: sugar pill
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990106
Locations
| United States, Washington | |
| VA Puget Sound Health Care System | |
| Seattle, Washington, United States, 98108 | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431 | |
Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
VA Puget Sound Health Care System
Investigators
| Study Chair: | Murray Raskind, MD | Department of Veterans Affairs Puget Sound Health Care System |
More Information
No publications provided
| Responsible Party: | Seattle Institute for Biomedical and Clinical Research |
| ClinicalTrials.gov Identifier: | NCT00990106 History of Changes |
| Other Study ID Numbers: | PT074250 |
| Study First Received: | October 2, 2009 |
| Last Updated: | February 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Seattle Institute for Biomedical and Clinical Research:
|
posttraumatic stress disorder PTSD nightmares |
prazosin sleep disturbance combat trauma |
Additional relevant MeSH terms:
|
Combat Disorders Sleep Disorders Parasomnias Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Signs and Symptoms Prazosin |
Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013