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

NCT00990106 | Completed Results DMC

• 2 other identifiers: PT0742501P20AA017839-01
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

posttraumatic stress disorder; PTSD; nightmares; prazosin; sleep disturbance; combat trauma

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Change from Baseline to Week 15

Study Arms (2)

prazosin hydrochloride

ACTIVE COMPARATOR

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.

Drug: prazosin hydrochloride

placebo

PLACEBO COMPARATOR

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.

Drug: placebo

Interventions

prazosin hydrochloride DRUG

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.

Also known as: prazosin, Pfizer Minipress

prazosin hydrochloride

placebo DRUG

placebo

Also known as: sugar pill

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• good general medical health.
• Female participants must agree to use a reliable form of birth control during the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• United States Department of Defense: collaborator
• VA Puget Sound Health Care System: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (2)

• 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.

  PMID: 23846759 RESULT

• 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.

  PMID: 27320368 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Combat Disorders; Sleep Wake Disorders; Parasomnias

Interventions

Prazosin; Sugars

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbohydrates

Limitations and Caveats

The sample was restricted to soldiers with frequent recalled combat trauma nightmares. More studies in civilian trauma PTSD are needed. Results cannot be extrapolated to persons with PTSD who do not recall trauma nightmares.

Results Point of Contact

• Title: Murray Raskind, MD
• Organization: VA Puget Sound Health Care System

Murray.Raskind@va.gov

206-277-3797

Study Officials

• Murray Raskind, MD

  Department of Veterans Affairs Puget Sound Health Care System

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2009
• First Posted: October 6, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 23, 2018
• Results First Posted: September 1, 2014

Record last verified: 2018-04

Locations

US (2)