A 52-Week, Open-Label Evaluation of the Long-term Efficacy and Safety of Single and Repeated Treatments With Methylone for the Treatment of PTSD IMPACT-EXT (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 9
- 主要终点
- Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total severity score
研究概览
简要总结
This is an extension study of participants who previously completed a Transcend-sponsored clinical trial evaluating TSND-201 as a treatment for PTSD.
Participants will be followed for up to 52 weeks. During the 52 week period, PTSD symptoms and safety will be assessed monthly.
Participants' PTSD symptoms will be assessed at each observational visit and if criteria for Relapse has been met, participants may be eligible to receive a course of TSND-201 treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in and successful completion of a prior Transcend-sponsored clinical trial with TSND-
- •Agree to not participate in any other interventional clinical trials for the duration of this study.
- •Willing and able to provide informed consent.
排除标准
- •Had significant deviation(s)/non-compliance in parent study in the opinion of the Investigator which would deem them unsuitable for participation.
- •Change or development of any physical or psychological finding that would make participant unsuitable for study.
研究组 & 干预措施
Treatment (Methylone)
干预措施: Methylone (Drug)
结局指标
主要结局
Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total severity score
时间窗: Up to 52 weeks
The CAPS-5 is a structured interview designed to assess PTSD symptom severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.
次要结局
- Incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), and treatment-emergent adverse events (TEAEs)(Up to 52 weeks)