Prazosin Treatment for Combat Trauma PTSD (Post-Traumatic Stress Disorder) Nightmares and Sleep Disturbance

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108420
First received: April 14, 2005
Last updated: January 20, 2009
Last verified: May 2007
  Purpose

The purpose of this study is to determine whether prazosin will reduce the incidence of nightmares, sleep disturbance, and overall symptoms in combat trauma-exposed individuals with PTSD.


Condition Intervention Phase
Stress Disorder, Post-Traumatic
Drug: Prazosin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prazosin Treatment for Combat Trauma PTSD Nightmares and Sleep Disturbance

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Clinical Global Impression of Change
  • Recurrent Distressing Dreams and Difficulty Falling and Staying Asleep items of the CAPS
  • Total CAPS (exclusive of the dreams and sleep items)
  • The Pittsburgh Sleep Quality Index
  • Depression
  • Quality of life

Study Start Date: October 2003
Estimated Study Completion Date: March 2007
Detailed Description:

The combat stress-related nightmares and sleep disturbance that often follow exposure to military combat are distressing and frequently persistent symptoms that impair quality of life and both occupational and social (e.g., family) function. One of the most frequently reported and most troubling symptoms of PTSD is trauma-content nightmares. These nighttime symptoms have been notoriously resistant to treatment with psychotropic medications such as anxiolytics, the SSRIs, and sedating antihistamines such as cyproheptadine. The SSRIs sertraline (Zoloft®) and paroxetine (Paxil®) are the only drugs FDA approved for PTSD. This approval was based on modest overall PTSD improvement compared to placebo in large multicenter trials that enrolled almost exclusively noncombat trauma subjects. Placebo-controlled SSRI trials for PTSD in combat veterans have been negative or equivocal.

Neurobiologic data suggest that combat stress-related nightmares and sleep disturbance in PTSD are related to enhanced central nervous system (CNS) adrenergic activity, particularly at night. Prazosin is a CNS-active, non-sedating alpha-1 antagonist that has long been generically available for the treatment of hypertension and benign prostatic hypertrophy. We recently demonstrated in Vietnam combat veterans with chronic PTSD that prazosin is robustly effective for previously treatment refractory combat trauma related nightmares, sleep disturbance and overall PTSD severity and functional impairment.

The goal of this study is to evaluate the efficacy and tolerability of prazosin compared to placebo for combat stress-related nightmares, sleep disturbance and overall function in combat-trauma exposed persons with PTSD.

Primary outcome measures will be Clinical Global Impression of Change, Recurrent Distressing Dreams and Difficulty Falling and Staying Asleep items of the CAPS, total CAPS (exclusive of the dreams and sleep items), and the Pittsburgh Sleep Quality Index. Depression and quality of life also will be assessed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Combat-trauma exposed persons with a diagnosis of PTSD
  • No diagnosis of lifetime schizophrenia, schizoaffective disorder, bipolar disorder, psychotic disorder, or any DSM-IV cognitive disorder; current delirium, or substance dependence disorder within 3 months of the study or current substance use other than alcohol (no more than 2 drinks/day); severe psychiatric instability or situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others
  • In good general medical health (no acute or significant chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension [systolic <110] or orthostatic hypotension [systolic drop > 20 mmHg after two minutes standing or any drop with dizziness]; insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, gout, Meniere's disease, benign positional vertigo, narcolepsy, allergy or previous adverse reaction to prazosin or other alpha-1 antagonist, or any unstable medical condition).
  • Stable dose of nonexcluded medications for concurrent stable medical conditions for at least 4 weeks prior to randomization.
  • Specific criteria used to validate presence of combat stress-related nightmares and sleep disturbance will include: score > 5 (of a maximum score of 8) on the CAPS Recurrent Distressing Dreams item. (CAPS score >5 places subjects in the upper third of nightmare severity) or score > 5 (of a maximum score of 8) on the CAPS Difficulty Falling or Staying Asleep item.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108420

Locations
United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00108420     History of Changes
Other Study ID Numbers: CLIN-018-02F
Study First Received: April 14, 2005
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Prazosin
Stress Disorders, Post-traumatic

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Dyssomnias
Sleep Disorders
Parasomnias
Pathologic Processes
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 September 30, 2014