A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Safety and Efficacy of Carvedilol Versus Placebo in the Treatment of Post Traumatic Stress Disorder
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Davidson Trauma Scale (DTS)
研究概览
简要总结
The investigators hypothesize that carvedilol, at less then therapeutic doses for cardiac effect, will reduce symptoms of Post Traumatic Stress Disorder.
详细描述
This initial proof of concept trial design is intended to explore multiple variables. Fist, it is intended to determine if carvedilol has any statistically significant effect over placebo on the various overall symptoms, symptom clusters, or individual symptoms of post traumatic stress disorder. Next, the flexible dosing trial design is aimed to detect the therapeutic dose, or dosing range for carvedilol when used in the treatment of PTSD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Post Traumatic Stress Disorder according to DSM-IV
- •Must be able to speak, read and understand the English language and be able to provide written informed consent
排除标准
- •current, unstable and significant medical condition/illness
- •bronchial asthma or related bronchospastic condition
- •Sick Sinus Syndrome
- •Bradycardia
- •Peripheral hear disease
- •Unstable thyroid disorder
- •History of seizure disorder
- •Females who are pregnant, lactating or planning to become pregnant
- •Schizophrenia
- •Intolerance or hypersensitivity to alpha or beta blockers
研究组 & 干预措施
carvedilol
Patients randomized to carvedilol will be administered doses ranging from 6.25 to 15.625 mg/day using a flexible-dosing model. After a 1 week titration, investigators my increase daily dose by 6.25 mg/day at weeks 1 and 2 for a maximum dose of 15.625 mg/day. Weeks 3-4 will patients will remain on a stable, tolerable dose. At week 5 patients will have a 1 week taper.
干预措施: Carvedilol (Drug)
Sugar Pill
Patients randomized to placebo will follow same dosing guidelines as if they were in the active comparator arm, carvedilol.
干预措施: Placebo (Drug)
结局指标
主要结局
Davidson Trauma Scale (DTS)
时间窗: 5 weeks
The DTS is a 17-item self report measure to assess the 17 DMS-IV symptoms of PTSD. Respondants are asked to identify the trauma that is most disturbing to them and to rate, in the past week, how much trouble they hav had with each symptom. The DTS can be used to make a preliminatry determination about whether the symptoms meet DSM criteria for PTSD, or scores can be calculated for each of the 3 PTSD symptom clusters. The DTS will be assessed at each study visit (visit 1, 2, 3, 4, 5, 6 and 7). The primary efficacy outcome will be change from baseline (visit 2) to week 5 (visit 7).
次要结局
- Clinician Administered PTSD Scale (CAPS)(6 Weeks)
- Insomnia Severity Index (ISI)(5 Weeks)