Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The Impact of Event Scale-Revised Japanese Version : IES-R-J
研究概览
简要总结
Accumulating evidence suggests a key role of the N-methyl-D-aspartate (NMDA) receptor in the pathophysiology of post-traumatic stress disorder (PTSD). Recent studies suggest that the NMDA receptor antagonist ifenprodil tartrate may be a potential therapeutic drug for PTSD. The purpose of this study is to confirm whether ifenprodil tartrate is effective in the treatment of adolescents PTSD patients. If ifenprodil tartrate is effective in these patients, this study contributes to the development of novel therapeutic drugs for PTSD.
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
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ifenprodil Tartrate
Oral Administration of Ifenprodil Tartrate 40mg/day (20mg After breakfast, 20mg After supper)
干预措施: Ifenprodil Tartrate (Drug)
Placebo
Oral Administration of Placebo (After breakfast, After supper)
干预措施: Placebo (Drug)
结局指标
主要结局
The Impact of Event Scale-Revised Japanese Version : IES-R-J
时间窗: Changes from baseline in IES-R-J at 4-weeks
Evidence includes retest reliability and internal consistency of the IES-R-J. Posttraumatic stress disorder (PTSD) and partial PTSD cases indicated significantly higher scores than non-PTSD cases. The IES-R-J can be a useful self-rating diagnostic instrument particularly for survivors with PTSD symptoms as a clinical concern (PTSD + partial PTSD) by using a 24/25 cutoff in total score. The IES-R-J can be used as a validated instrument in future international comparative research.
次要结局
- Trauma Symptom Checklist for Children Japanese Version : TSCC-J(Changes from baseline in TSCC-J at 4-weeks)
研究者
Tsuyoshi Sasaki
Tsuyoshi Sasaki, Clinical Associate Professor
Chiba University