Repeated Ketamine Treatment to Accelerate Efficacy of Prolonged Exposure in PTSD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
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 to reduce symptoms of Posttraumatic Stress Disorder (PTSD) among Veteran receiving Prolonged Exposure Therapy.
详细描述
In this single site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine in conjunction with prolonged exposure (PE) therapy for PTSD. Veterans who meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized to one of two treatment arms (placebo plus PE vs ketamine plus PE). Participants receive the study drug via intravenous infusion once per week for 3-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)
盲法说明
The investigators will use a sequentially numbered, opaque, sealed envelopes, pharmacy-controlled allocations, and coded identical containers for adequate concealment allocation. Administration of study drugs and infusion monitoring will be conducted by research nurse keeping blinding from investigators and independent outcome assessors.
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
- •male or female Veterans between the ages of 18 and 75 years
- •diagnosis of PTSD
- •ability to provide written informed consent
排除标准
- •females who are currently pregnant or breastfeeding
- •current high risk for suicide
- •history of moderate/severe head injury
- •history of psychosis
- •current episode of mania/hypomania
- •severe substance and/or alcohol use disorder in the last 6 months
研究组 & 干预措施
Ketamine and prolonged exposure (PE)
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
干预措施: Ketamine (Drug)
Midazolam and prolonged exposure (PE)
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
干预措施: Midazolam (Drug)
结局指标
主要结局
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
时间窗: CAPS-5 to measure change in PTSD symptoms from baseline to post-treatment (10 weeks)
The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
时间窗: Baseline
The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
时间窗: Week 4
The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
时间窗: Week 10
The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
时间窗: Week 14
The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
时间窗: Week 22
The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.
次要结局
未报告次要终点