A Pilot Study to Assess the Effects of Doxazosin on Polysomnography in PTSD
This study will assess the effects of the medication doxazosin on sleep in men and women with PTSD. Sleep will be measured objectively at home using a portable sleep recorder and wrist actigraphy.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Assess the Effects of Doxazosin on Polysomnography in PTSD|
- Change in mean total sleep time and wake-time after sleep onset as measured by polysomnography and actigraphy [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
- Change in REM sleep time and REM period duration as measured by polysomnography [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
- Change in mean scores on the CAPS, CAPS sleep and distressing dreams items, PCL, BDI, ISI, PSQI, PSQI-A and QOLI [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Doxazosin XL
Subjects will participate in a 2 week flexible-dose titration of doxazosin XL based on clinical response and adverse effects followed by 6 weeks of steady dose treatment.
Drug: Doxazosin XL
Subjects will participate in a 2 week flexible-dose titration of doxazosin based on clinical response and adverse effects followed by 6 weeks of steady dose treatment.
Other Name: Cardura XL
This pilot study will assess the effects of doxazosin on objective measures of sleep in PTSD subjects using home ambulatory polysomnography. Twenty (20) men and women with chronic PTSD will be enrolled at the San Francisco Veterans Affairs Medical Center. After initial screening, subjects will complete 1 week of baseline assessments including 2 nights of home ambulatory polysomnography. They will then participate in a 2-week flexible-dose titration of doxazosin based on clinical response and adverse effects followed by 6 weeks of steady dose treatment ending with 2 nights of home polysomnography. Subjective and rater-based assessments will be conducted at baseline and at set intervals during and at the end of treatment. Wrist actigraphy measurements will also be made at baseline and at end of treatment as an economical, fairly valid and unobtrusive measure of sleep duration. We hypothesize that doxazosin will be associated with an increase in total sleep time (TST) and a decrease in wake time after sleep onset (WASO). We hypothesize that doxazosin will also be associated with clinical gains with respect to nightmares, subjective sleep quality, non-sleep PTSD symptoms, depression symptoms, and quality of life.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01959022
|Contact: Christen Waldon, MSW||415-221-4810 ext firstname.lastname@example.org|
|United States, California|
|San Francisco Veterans Affairs Medical Center||Recruiting|
|San Francisco, California, United States, 94121|
|Contact: Christen Waldon, MSW 415-221-4810 ext 3809 email@example.com|
|Principal Investigator: Anne Richards, MD, MPH|
|Principal Investigator:||Anne Richards, MD, MPH||San Francisco Veterans Affairs Medical Center|