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

Sponsor:	Seattle Institute for Biomedical and Clinical Research
Collaborators:	Department of Defense VA Puget Sound Health Care System
Information provided by:	Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:	NCT00990106

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 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:

MedlinePlus related topics: Injuries Post-Traumatic Stress Disorder Sleep Disorders Wounds

Drug Information available for: Prazosin Prazosin hydrochloride

U.S. FDA Resources

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:	210
Study Start Date:	September 2009
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (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: prazosin Pfizer Minipress
Placebo Comparator: placebo	Drug: placebo placebo Other Name: sugar pill

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:

prazosin
Pfizer Minipress

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, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
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

Department of Defense

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:	Murray Raskind, MD, VA Puget Sound HCS
ClinicalTrials.gov Identifier:	NCT00990106 History of Changes
Other Study ID Numbers:	PT074250
Study First Received:	October 2, 2009
Last Updated:	April 25, 2011
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 February 09, 2012