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NCT00532493 · ClinicalTrials.gov registry record · Phase 3
Cooperative Studies Program #563 - Prazosin and Combat Trauma PTSD
A Phase 3 study of PTSD and Sleep Disorders, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 304
- Enrollment target
- 15
- Study locations
NCT00532493: Completed Phase 3 study of PTSD and Sleep Disorders, sponsored by VA Office of Research and Development.
NCT00532493 is a Phase 3 study of PTSD and Sleep Disorders that has completed, run by VA Office of Research and Development. The registered enrollment target is 304 participants, roughly in line with the 300-participant average among 154 other PTSD trials with a reported enrollment target. The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00532493, a Phase 3 study of PTSD and Sleep Disorders, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 304 participants
- Enrollment target
- 15
- Study locations
Study Summary
Background: Posttraumatic stress disorder (PTSD) is a debilitating and disabling mental disorder that afflicts at least 25% of Veterans who have suffered life-threatening war zone trauma. Trauma-related nightmares and sleep disturbance are among the most treatment-resistant PTSD symptoms in Veterans. Increased responsiveness to central nervous system (CNS) norepinephrine (NE) contributes to the pathophysiology of overall PTSD and treatment-resistant nighttime symptoms. Placebo-controlled pilot studies demonstrate that the generically available CNS-active alpha-1 adrenoreceptor antagonist prazosin substantially reduces PTSD trauma nightmares and sleep disturbance and improves global clinical status (sense of well being and ability to function) in Veterans. Objective: The primary objective is to demonstrate in a large multi-site placebo-controlled trial in Veterans with war zone trauma-induced PTSD that prazosin is efficacious for PTSD trauma nightmares, sleep disturbance, and global clinical status. A secondary objective is to demonstrate prazosin effectiveness for these outcome measures during clinically meaningful long-term (26 week) maintenance treatment of PTSD. The investigators will also address prazosin efficacy and long-term effectiveness for improving total PTSD symptoms, comorbid depression, quality of life, and physical functioning. Methods: This 26 week randomized double-blind placebo-controlled study is designed to demonstrate both short term efficacy and long term effectiveness of prazosin for PTSD. The research design encompasses a shorter-term, more tightly controlled efficacy component and a longer-term, more .real world. effectiveness component. Three hundred twenty-six Veterans with war zone -related PTSD and persistent trauma nightmares will be randomized 1:1 to prazosin or placebo. Study drug will be increased using a flexible dose titration schedule based on clinical response and adverse effects to an optimum maintenance dose (1-20 mg/day). Du
Primary Outcome
Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.
Conditions Studied
Interventions
- OTHER placebo
- DRUG prazosin
Study Locations (15)
California
- VA Medical Center, Loma Linda - Loma Linda
- VA Medical Center, Long Beach - Long Beach
- VA Palo Alto Health Care System - Palo Alto
North Carolina
- VA Medical Center, Durham - Durham
- Salisbury VAMC - Salisbury
Florida
- VA Medical Center, Miami - Miami
Georgia
- Atlanta VA Medical and Rehab Center, Decatur - Decatur
Missouri
- VA Medical Center, Kansas City MO - Kansas City
New Mexico
- New Mexico VA Health Care System, Albuquerque - Albuquerque
New York
- New York Harbor HCS - New York
Rhode Island
- VA Medical Center, Providence - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2010-01-06 |
| Est. Completion | 2013-05-31 |
| Phase | Phase 3 |
What the finished NCT00532493 record still lists
NCT00532493 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 300-participant average among 154 other PTSD trials with a reported enrollment target.
The record links to 2 conditions, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00532493 lists 15 locations in 12 states (California, North Carolina, Florida).
Frequently Asked Questions
What is clinical trial NCT00532493 about?
NCT00532493 is a clinical study titled "Cooperative Studies Program #563 - Prazosin and Combat Trauma PTSD". Background: Posttraumatic stress disorder (PTSD) is a debilitating and disabling mental disorder that afflicts at least 25% of Veterans who have suffered life-threatening war zone trauma. Trauma-related nightmares and sleep disturbance are among the most treatment-resistant PTSD symptoms in Veterans...
What is the current status of trial NCT00532493?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 304 participants. The study started on 2010-01-06. Estimated completion is 2013-05-31.
What conditions does trial NCT00532493 study?
This clinical trial studies the following conditions: PTSD, Sleep Disorders.
What interventions are being tested in trial NCT00532493?
The interventions under investigation include: placebo (OTHER), prazosin (DRUG).
Who is sponsoring clinical trial NCT00532493?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00532493 being conducted?
This trial has 15 study locations across California, Florida, Georgia, Missouri, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for PTSD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00532493's enrollment target sits among peer trials
304 17th of 154 higher than 138 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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