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

This study has been completed.
Sponsor:
Collaborators:
United States Department of Defense
Northern California Institute of Research and Education
Information provided by (Responsible Party):
Anne Richards, San Francisco Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01959022
First received: October 4, 2013
Last updated: October 19, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Stress Disorders, Post-Traumatic Drug: Doxazosin XL Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Effects of Doxazosin on Polysomnography in PTSD

Resource links provided by NLM:


Further study details as provided by Anne Richards, San Francisco Veterans Affairs Medical Center:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: October 2013
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01959022

Locations
United States, California
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
San Francisco Veterans Affairs Medical Center
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
  More Information

Publications:
Responsible Party: Anne Richards, Staff Psychiatrist, San Francisco Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01959022     History of Changes
Other Study ID Numbers: A-16907.5
Study First Received: October 4, 2013
Last Updated: October 19, 2016

Keywords provided by Anne Richards, San Francisco Veterans Affairs Medical Center:
Posttramatic Stress Disorder
Post-traumatic Stress Disorder
PTSD
Doxazosin
Nightmares
Sleep Disturbance

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Doxazosin
Antihypertensive Agents
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 September 21, 2017