Prazosin Treatment for Combat Trauma PTSD (Post-Traumatic Stress Disorder) Nightmares and Sleep Disturbance
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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 |
- 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 |
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 |
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 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:
|
Sleep Disorders Dyssomnias Parasomnias Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Anxiety Disorders 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 19, 2013