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

NCT ID: NCT01959022

Last Updated: 2016-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-06-30

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.

Conditions

Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Doxazosin XL

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Cardura XL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Northern California Institute of Research and Education

OTHER

Sponsor Role: collaborator

San Francisco Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Anne Richards

Staff Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Richards, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

San Francisco Veterans Affairs Medical Center

Locations

San Francisco Veterans Affairs Medical Center

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20075659 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17868655 (View on PubMed)

Other Identifiers

A-16907.5

Identifier Type: -

Identifier Source: org_study_id