A Randomized Double-blind Placebo-controlled Cross-over Trial of Hydrocortisone for Post-traumatic Stress Disorder
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Clinical Global Impressions - Improvement (CGI-I)
研究概览
简要总结
Developing novel and effective pharmacologic interventions for this post-traumatic stress disorder is important. The investigators propose to replicate findings of an earlier published pilot study using low dose hydrocortisone as a treatment for PTSD. In order to do so in a more meaningful way, the investigators will conduct a larger but similar randomized double-blind placebo-controlled, cross-over design treatment study examining the use of low dose hydrocortisone (or placebo) for 4 weeks in combat veterans suffering from PTSD.
The investigators hypothesize that, as described by Aerni et al. (2004), administration of daily hydrocortisone will lead to a reduction in PTSD symptom severity, but particularly for re-experiencing types (e.g., flashbacks, nightmares)of symptoms. The investigators also hope to examine potential predictors and moderators of treatment response based on subjects' clinical characteristics, as well as serum cortisol and ACTH levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male military veterans
- •Between the ages of 18-65 years old
- •Generally good medical health with no clinically significant abnormalities on physical examination, electrocardiogram, or laboratory findings
- •Ability to provide informed consent and comply with requirements of study protocol
- •No specific contraindications to hydrocortisone
- •Clinically predominant DSM-IV diagnosis of PTSD
- •Score of ≥ 40 on Clinician Administered PTSD Scale [CAPS]
排除标准
- •History of moderate to severe traumatic brain injury, seizure or organic mental illness
- •Lifetime history of schizophrenia, bipolar disorder, other psychotic disorder, or depression with a score of ≥ 16 on the 17-item Hamilton Depression Rating Scale (Hamilton, 1960), active suicidal ideation
- •Unstable medical illness
- •Subjects undergoing any formal psychotherapy within 3 months of enrollment
- •Subjects that meet criteria for substance dependence during the last 6 months
- •History of adverse reaction to corticosteroids.
- •Concurrent use of other psychotropic medication (e.g. benzodiazepines, antipsychotics)
研究组 & 干预措施
Hydrocortisone
干预措施: Hydrocortisone (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Global Impressions - Improvement (CGI-I)
时间窗: Week 0,2,4,6,8,10
Clinician Administered PTSD Scale (CAPS)
时间窗: Week 0,2,4,6,8,10
次要结局
- Brief Symptom Inventory - 18 item (BSI-18)(Week 0,2,4,6,8,10)
- Sheehan Disability Inventory (SDI)(Week 0,4,6,10)