Administration of Prazosin to Prevent PTSD After Sexual Assault
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in PTSD symptoms and severity - Clinician-Administered PTSD Scale - 5 (CAPS-5)
研究概览
简要总结
This study plans to learn more about whether taking the medication, Prazosin, immediately and during the weeks immediately following a traumatic event can help to reduce the risk of developing posttraumatic stress disorder (PTSD). Early post traumatic event sleep disturbance predicts the later development of PTSD. Prazosin has shown some effectiveness in reducing trauma related nightmares and sleep disturbance. We hypothesize that regulating sleep immediately after a sexual assault will reduce PTSD and diminish symptoms.
详细描述
This study plans to learn more about whether taking the medication, Prazosin, in the weeks immediately following a traumatic event can help to reduce the risk of developing posttraumatic stress disorder (PTSD).
Specific Aim 1: Test the efficacy of the drug prazosin in decreasing PTSD symptom severity as compared to placebo at 3 months post rape as measured by the Clinician-Administered PTSD Scale version 5 (CAPS-5, primary outcome) as well as associated secondary outcomes (PTSD diagnosis rate, sleep scores, and depression symptoms) at 3 months.
Hypotheses:
1a: Severity score on the CAPS-5 will be significantly lower in rape victims randomized to receive prazosin within 24 hours of at the University of Colorado Hospital (UCH) Emergency Department and continue on a titrated dose for one month compared to the control group at 3 months post rape. Secondarily, PTSD diagnosis rate will be lower in the prazosin group versus the control group at 3 months.
1b: Participants randomized to receive prazosin will have better sleep scores as measured by the Pittsburgh Sleep Quality Index (PSQI) and PSQI Trauma addendum at 3 months post rape as compared to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a randomized double-blind placebo-controlled trial. All study team personnel (PI, RAs) and study participants will be blinded to intervention condition [prazosin (treatment) vs. placebo (control)] throughout active data collection.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients between the ages of 18 years and 50 years
- •Victim of sexual assault/rape
- •Able to understand consent procedure
- •Discharged to home
排除标准
- •Admitted to inpatient unit
- •Previous diagnosis of PTSD
- •Contra-indications to prazosin: orthostatic hypotension, right heart failure, use of anti-hypertensive medication, 5-phosphodiesterase inhibitors (sildenafil) or diuretic, history of syncope or severe unexplained faintness, known hypersensitivity to quinazolines
- •Hemodynamically unstable
- •Current use of over the counter, prescribed, or use of other drugs for insomnia
- •Dependence on alcohol, opiates or other illegal drugs
- •History of psychotic disorder
- •Suicidal risk defined by a positive response on the 3-item assessment, standard protocol in the ED
- •Current use of morphine or methadone
- •Pregnant or breastfeeding
- •Known hepatic dysfunction
- •Cardiac or vascular history including coronary artery disease
- •Narcolepsy
- •History of sleep apnea
- •Returning to chronic domestic abuse situation
研究组 & 干预措施
Treatment - prazosin
Participants randomized to this group will receive the medication prazosin.
干预措施: Prazosin (Drug)
Control - placebo
Participants randomized to this group will receive placebo .
干预措施: Placebos (Drug)
结局指标
主要结局
Change in PTSD symptoms and severity - Clinician-Administered PTSD Scale - 5 (CAPS-5)
时间窗: The full interview takes 45-60 minutes to administer and will be given at baseline, at approximately 31 days post event, and at three months.
Clinician-Administered PTSD Scale-5 (CAPS-5) - Past Month \& Past Week. The CAPS is the gold standard in PTSD assessment and the total score will serve as the primary outcome. The CAPS-5 is a 30-item structured interview to make a current (past month) diagnosis of PTSD, a lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The full interview takes 45-60 minutes to administer and will be given at baseline, at approximately 31 days post event, and at three months.
次要结局
- Pittsburgh Sleep Quality Index (PSQI)(The PSQI will be completed weekly through study completion (average three months).)
- Pittsburgh Sleep Quality Index - Trauma Addendum (PSQI-A)(The PSQI-A will be completed weekly through study completion (average three months).)
- Patient Health Questionnaire (PHQ-9)(It takes about five minutes to complete and will be assessed weekly for the first seven weeks of participation and at three months/study completion (at each study visit).)