An Open-label Clinical Outcomes Study to Determine the Safety and Efficacy of Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder and Gulf War Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- SF-36 general health survey
研究概览
简要总结
An open-label clinical outcomes study to determine the safety and efficacy of Sentra AM® and Sentra PM® for post-traumatic stress disorder (PTSD) and Gulf War fibromyalgia (GWF).
详细描述
Male and female military veterans age 18 to 75 experiencing moderate to severe PTSD symptoms including cognitive dysfunction, sleep disorders and mood disorders.
Open-label internet questionnaire-based clinical outcomes study. 250 subjects. 60 days from enrollment initiation to completion and study close. Sentra AM- two capsules given orally once daily in the morning for 30 days. Sentra PM- two capsules given orally once daily thirty minutes before bedtime for 30 days.
To measure improvement in quality of life determined by the change in short form-36 (SF-36) general health survey.
Improvements in daytime sleepiness determined by the Epworth Sleepiness Scale (ESS), improvement in cognitive and emotional function using the Cognitive emotion regulation questionnaire - short (CERQ-Short), change in PTSD symptoms with the Primary Care - PTSD (PC-PTSD), Psychopathy Checklist- Military (PCL-M). Heart rate variability (HRV) data variation will be measured in a group of twenty subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •United States military veterans reporting PTSD and/or Gulf War Illness symptoms at least three months after return from duty.
- •Men and non-pregnant, non-lactating women over the age of 18 and under the age of 75, able to read and understand English-language informed consent.
- •Men and women of child-bearing potential willing to use adequate contraception, not to become pregnant or impregnate their partner for the study duration.
- •Patients who will continue on a stable dose (no less than three months) of other medications they are taking and maintain the same dose throughout the duration of the study.
- •Patients willing to commit to completing all clinical questionnaires and guidelines during study-related procedures.
排除标准
- •Patients who have previously taken Sentra AM or Sentra PM.
- •Patients not fluent in English.
- •Participation in a clinical trial within one (1) month prior to screening.
- •Uncontrolled or unstable serious cardiovascular, pulmonary, gastrointestinal, endocrine or neurologic disorder.
结局指标
主要结局
SF-36 general health survey
时间窗: Baseline and Day 30
A general health questionnaire to measure quality of life. Change from baseline.
次要结局
- Epworth Sleepiness Scale(Baseline and Day 30)
- CERQ-short(Baseline and Day 30)
- PCL-Military(Baseline and Day 30)
研究者
Stephanie Pavlik
Clinical Research Associate
Targeted Medical Pharma