CAP-Ketamine for Antidepressant Resistant PTSD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 3
- 主要终点
- PTSD Checklist (PCL)
研究概览
简要总结
The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo, in reducing symptoms of Posttraumatic Stress Disorder (PTSD) in an active duty military and Veteran population.
详细描述
In this 2-site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine for treatment resistant PTSD, Veterans and active duty military personnel who meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized to one of three treatment arms (placebo, low dose ketamine, high dose ketamine). Participants receive the study drug via intravenous infusion twice per week for 4-weeks.
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
- •male or female Veterans or active duty military personnel between the ages of 18 and 70 years
- •diagnosis of PTSD
- •history of trialing one or more antidepressant medications with little to no PTSD symptom improvement
- •ability to provide written informed consent
排除标准
- •females who are currently pregnant or breastfeeding
- •current high risk for suicide
- •history of severe head injury
研究组 & 干预措施
Placebo
Saline dose
干预措施: Placebo/Saline (Drug)
Low Dose Ketamine
Low Dose Ketamine (.20 mg/kg)
干预措施: Ketamine (Drug)
High Dose Ketamine
High Dose Ketamine (.50 mg/kg)
干预措施: Ketamine (Drug)
结局指标
主要结局
PTSD Checklist (PCL)
时间窗: Session 1 -Day 0
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
The PTSD Checklist (PCL)
时间窗: Follow-up 7 - Day 56
The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
次要结局
- Montgomery-Asberg Depression Rating Scale (MADRS)(Follow-up 7 - Day 56)