Effects of Hydrocortisone and D-Cycloserine on Fear Extinction in Veterans With Posttraumatic Stress Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)
研究概览
简要总结
This is a research study examining the use of two medications, Hydrocortisone and D-Cycloserine, compared to an inactive substance (placebo), on their ability to reduce fear responses and memory of fear in Veterans with symptoms of Posttraumatic Stress Disorder (PTSD). These responses will be tested using a fear learning and memory task administered by computer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Veterans and civilians with an age range of 18 to 65 years
- •Participants must be physically healthy volunteers
排除标准
- •Individuals who fall outside the age range
- •Individuals with medical conditions that would interfere with participation
- •Other criteria
研究组 & 干预措施
Arm 1: Hydrocortisone
Hydrocortisone
干预措施: Hydrocortisone (Drug)
Arm 2: D-Cycloserine
D-Cycloserine
干预措施: D-Cycloserine (Drug)
Arm 3: Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)
时间窗: 15 minute measurement intervals on Study Days 7, 9, and 16
Psychophysiology measurements occurred on day 7 for fear conditioning, day 9 for fear extinction, and day 11 for extinction retention. The primary outcome measures are presented for the first and last conditioned stimulus (CS) trials during fear conditioning and extinction and for the first 2 trials during retention. Conditioned Responses (CR): An SCR score was obtained for each CS by subtracting the mean skin conductance level (SCL) in microsiemens (µS) for the 2-s interval immediately preceding CS onset from the max SC level in µS during the 8-s CS presentation. Unconditioned Response (UCR): An SCR score for the UCR was obtained by subtracting the mean SCL in µS within 6-8 s following CS offset from the max increase in SC level during the .5-6.5 time interval following the CS offset, corresponding to the onset of the .5s US. SC responses were range corrected using each participant's maximum response to the UCS or CS during acquisition trials of the fear conditioning phase.
次要结局
未报告次要终点