Feasibility Study: The Effect of Prazosin for Nighttime Symptoms of Civilian PTSD
Primary Purpose
Stress Disorders, Post-Traumatic
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
prazosin
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic
Eligibility Criteria
Inclusion Criteria: must meet DSM-IV criterion for PTSD Exclusion Criteria: Must not have untreated sleep apnea
Sites / Locations
- Fletcher B. Taylor
Outcomes
Primary Outcome Measures
Sleep time
REM sleep time
Nightmare frequency
CGI
Secondary Outcome Measures
Distressed Awakenings frequency
PCL-C
Full Information
NCT ID
NCT00174551
First Posted
September 9, 2005
Last Updated
September 7, 2006
Sponsor
Rainier Associates
1. Study Identification
Unique Protocol Identification Number
NCT00174551
Brief Title
Feasibility Study: The Effect of Prazosin for Nighttime Symptoms of Civilian PTSD
Official Title
The Effect of Prazosin for Nighttime Symptoms of Civilian PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rainier Associates
4. Oversight
5. Study Description
Brief Summary
Investigating the effect of prazosin for nighttime symptoms of civilian Posttraumatic Stress Disorder.
Detailed Description
Each subject will receive prazosin and placebo trials, the order randomized. Day and nighttime symptoms will be monitored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
prazosin
Primary Outcome Measure Information:
Title
Sleep time
Title
REM sleep time
Title
Nightmare frequency
Title
CGI
Secondary Outcome Measure Information:
Title
Distressed Awakenings frequency
Title
PCL-C
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
must meet DSM-IV criterion for PTSD
Exclusion Criteria:
Must not have untreated sleep apnea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fletcher B Taylor, M.D.
Organizational Affiliation
Rainier Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fletcher B. Taylor
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98467
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study: The Effect of Prazosin for Nighttime Symptoms of Civilian PTSD
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