A Placebo-controlled, Randomized, Double-blind Comparison of Placebo vs Short Course Low Dose Corticosteroids on Posttraumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Clinician-Administered PTSD Scale (CAPS)
研究概览
简要总结
The purpose of this study is to investigate if a 2-wk course of 20mg/day of oral prednisone in addition to standard care will result in reduced PTSD symptoms or symptom severity compared to placebo
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for PTSD w/ symptom exacerbation (CAPS score ≥ 50)
- •Stable on other psychotropic meds x1 month
排除标准
- •Current or past history of bipolar, schizophrenic, or other psychotic disorder
- •Organic mental disorder
- •Alcohol or substance abuse in last 3 months
- •Clinically significant hepatic or renal disease or other acute or unstable medical condition
- •Chronic obstructive pulmonary disease (COPD), asthma, uncontrolled diabetes, rheumatologic diseases
研究组 & 干预措施
Prednisone
Prednisone 20mg daily x 2 weeks
干预措施: prednisone (Drug)
placebo
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change in Clinician-Administered PTSD Scale (CAPS)
时间窗: baseline, 2 weeks, 6 weeks, 12 weeks
This measure tests the hypothesis that there will be a 30% or greater improvement in the Clinician-Administered PTSD (Post Traumatic Stress Disorder) Scale over the course of the study. CAPS is a 30-item survey with a total possible range of scores from 0-120 where the higher the score, the more severe the symptoms.
Number of Participants Achieving CAPS Response
时间窗: baseline, 2 weeks, 6 weeks, 12 weeks
CAPS response defined as a 30% reduction in CAPS score from baseline.
次要结局
- Change in Salivary Cortisol (First 6 Participants)(Baseline, 2 weeks, 6 weeks, and 12 weeks)
- Change in Salivary Cortisol (Last 6 Participants)(Baseline, 2 weeks, 6 weeks, and 12 weeks)
- Change in Serum Glucose(Baseline, 2 weeks, 6 weeks, and 12 weeks)
- Number of Other Adverse Events(up to 3 weeks)
- Change in Clinical Global Impression Severity (CGI-S) Score(baseline, 2 weeks, 6 weeks, 12 weeks)
- Change in Dehydroepiandrosterone Sulfate (DHEA-S)(Baseline, 2 weeks, 6 weeks, and 12 weeks)
- Change in Hamilton Depression Rating Scale (HAM-D)(baseline, 2 weeks, 6 weeks, 12 weeks)
- Change in PCL-PTSD Score(baseline, 2 weeks, 6 weeks, 12 weeks)