A Pilot Study to Assess the Effects of Doxazosin on Polysomnography in PTSD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in mean total sleep time and wake-time after sleep onset as measured by polysomnography and actigraphy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Doxazosin XL (Drug)
结局指标
主要结局
Change in mean total sleep time and wake-time after sleep onset as measured by polysomnography and actigraphy
时间窗: baseline and 8 weeks
Change in REM sleep time and REM period duration as measured by polysomnography
时间窗: baseline and 8 weeks
次要结局
- 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)
研究者
Anne Richards
Staff Psychiatrist
San Francisco Veterans Affairs Medical Center