A Pilot Study to Assess the Effects of Doxazosin on Polysomnography in PTSD

October 19, 2016 updated by: Anne Richards, San Francisco Veterans Affairs Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • San Francisco Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-69
  2. Current full or partial syndromal PTSD of at least 3 months duration as indexed by the CAPS (Clinician-administered PTSD scale) score >30
  3. CAPS recurrent distressing dreams item of >/= 5

Exclusion Criteria:

  1. alcohol and or drug abuse/dependence in the last 3 months
  2. lifetime history of any psychiatric disorder with psychotic features, bipolar disorder, obsessive-compulsive disorder
  3. exposure to trauma within the last 3 months
  4. prominent suicidal or homicidal ideation
  5. sleep apnea diagnosis or positive screen for sleep apnea by Type III device.
  6. neurologic disorder or systemic illness affecting CNS function
  7. history of brain trauma or head injury with loss of consciousness greater than 10 minutes
  8. chronic or unstable medical illness including unstable angina, myocardial infarction within the past 6 months, congestive heart failure, preexisting hypotension or orthostatic hypotension, chronic renal or hepatic failure, and pancreatitis
  9. pregnancy, breastfeeding and/or refusal to use effective birth control
  10. previous serious adverse reaction to an alpha-1-antagonist (such as priapism, hepatitis, angioedema, or intraoperative floppy iris syndrome)
  11. current use of trazodone, hypnotics/benzodiazepines, mirtazapine, atypical antipsychotics, beta-adrenergic blockers, alpha-2-agonists, and current prazosin or other alpha-1-antagonists
  12. previous non-response to prazosin for treatment of PTSD related sleep disturbance

Participants taking SSRIs, bupropion, venlafaxine and duloxetine may be included if they have been on a stable dose for 2 months. Participants may be included if they have been stable in psychotherapy treatment for 2 months and/or if they begin no new psychotherapy while in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Cardura XL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in mean total sleep time and wake-time after sleep onset as measured by polysomnography and actigraphy
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Change in REM sleep time and REM period duration as measured by polysomnography
Time Frame: baseline and 8 weeks
baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Francisco Veterans Affairs Medical Center

Collaborators

United States Department of Defense
Northern California Institute of Research and Education

Investigators

  • Principal Investigator: Anne Richards, MD, MPH, San Francisco Veterans Affairs Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 4, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 9, 2013

Study Record Updates

Last Update Posted (Estimate)

October 20, 2016

Last Update Submitted That Met QC Criteria

October 19, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-16907.5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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