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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959022
• Other study ID #: A-16907.5
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2013
• Last updated: October 19, 2016
• Start date: October 2013
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: San Francisco Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	San Francisco Veterans Affairs Medical Center	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
San Francisco Veterans Affairs Medical Center	Northern California Institute of Research and Education, United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Epub 2007 Sep 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean total sleep time and wake-time after sleep onset as measured by polysomnography and actigraphy		baseline and 8 weeks	No
Primary	Change in REM sleep time and REM period duration as measured by polysomnography		baseline and 8 weeks	No
Secondary	Change in mean scores on the CAPS, CAPS sleep and distressing dreams items, PCL, BDI, ISI, PSQI, PSQI-A and QOLI		baseline and 8 weeks	No

External Links

•   Stress and Health Research Program - REST Study