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

Primary Purpose

Stress Disorders, Post-Traumatic

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Doxazosin XL

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Posttramatic Stress Disorder, Post-traumatic Stress Disorder, PTSD, Doxazosin, Nightmares, Sleep Disturbance

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

alcohol and or drug abuse/dependence in the last 3 months
lifetime history of any psychiatric disorder with psychotic features, bipolar disorder, obsessive-compulsive disorder
exposure to trauma within the last 3 months
prominent suicidal or homicidal ideation
sleep apnea diagnosis or positive screen for sleep apnea by Type III device.
neurologic disorder or systemic illness affecting CNS function
history of brain trauma or head injury with loss of consciousness greater than 10 minutes
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
pregnancy, breastfeeding and/or refusal to use effective birth control
previous serious adverse reaction to an alpha-1-antagonist (such as priapism, hepatitis, angioedema, or intraoperative floppy iris syndrome)
current use of trazodone, hypnotics/benzodiazepines, mirtazapine, atypical antipsychotics, beta-adrenergic blockers, alpha-2-agonists, and current prazosin or other alpha-1-antagonists
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.

Sites / Locations

San Francisco Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Doxazosin XL

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in mean total sleep time and wake-time after sleep onset as measured by polysomnography and actigraphy

Change in REM sleep time and REM period duration as measured by polysomnography

Secondary Outcome Measures

Change in mean scores on the CAPS, CAPS sleep and distressing dreams items, PCL, BDI, ISI, PSQI, PSQI-A and QOLI

Full Information

NCT ID

NCT01959022

First Posted

October 4, 2013

Last Updated

October 19, 2016

Sponsor

San Francisco Veterans Affairs Medical Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01959022

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

San Francisco Veterans Affairs Medical Center

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Disorders, Post-Traumatic

Keywords

Posttramatic Stress Disorder, Post-traumatic Stress Disorder, PTSD, Doxazosin, Nightmares, Sleep Disturbance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Doxazosin XL

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Doxazosin XL

Other Intervention Name(s)

Cardura XL

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in mean total sleep time and wake-time after sleep onset as measured by polysomnography and actigraphy

Time Frame

baseline and 8 weeks

Title

Change in REM sleep time and REM period duration as measured by polysomnography

Time Frame

baseline and 8 weeks

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-69 Current full or partial syndromal PTSD of at least 3 months duration as indexed by the CAPS (Clinician-administered PTSD scale) score >30 CAPS recurrent distressing dreams item of >/= 5 Exclusion Criteria: alcohol and or drug abuse/dependence in the last 3 months lifetime history of any psychiatric disorder with psychotic features, bipolar disorder, obsessive-compulsive disorder exposure to trauma within the last 3 months prominent suicidal or homicidal ideation sleep apnea diagnosis or positive screen for sleep apnea by Type III device. neurologic disorder or systemic illness affecting CNS function history of brain trauma or head injury with loss of consciousness greater than 10 minutes 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 pregnancy, breastfeeding and/or refusal to use effective birth control previous serious adverse reaction to an alpha-1-antagonist (such as priapism, hepatitis, angioedema, or intraoperative floppy iris syndrome) current use of trazodone, hypnotics/benzodiazepines, mirtazapine, atypical antipsychotics, beta-adrenergic blockers, alpha-2-agonists, and current prazosin or other alpha-1-antagonists 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Richards, MD, MPH

Organizational Affiliation

San Francisco Veterans Affairs Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Francisco Veterans Affairs Medical Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94121

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20075659

Citation

De Jong J, Wauben P, Huijbrechts I, Oolders H, Haffmans J. Doxazosin treatment for posttraumatic stress disorder. J Clin Psychopharmacol. 2010 Feb;30(1):84-5. doi: 10.1097/JCP.0b013e3181c827ae. No abstract available.

Results Reference

background

PubMed Identifier

17868655

Citation

Taylor FB, Martin P, Thompson C, Williams J, Mellman TA, Gross C, Peskind ER, Raskind MA. Prazosin effects on objective sleep measures and clinical symptoms in civilian trauma posttraumatic stress disorder: a placebo-controlled study. Biol Psychiatry. 2008 Mar 15;63(6):629-32. doi: 10.1016/j.biopsych.2007.07.001. Epub 2007 Sep 14.

Results Reference

background

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

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