NCT06589505招募中2 期
A Multicenter, Randomized, Double-blind, Parallel-group Comparative Study to Assess Efficacy and Safety of Software as a Medical Device in Patients With Post-Traumatic Stress Disorder (PTSD)
Otsuka Medical Devices Co., Ltd. Japan66 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 66
- 主要终点
- Clinician-Administered PTSD Scale for DSM-5
研究概览
简要总结
To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PTSD according to the DSM-5
- •Subjects who are within 1 to 20 years since index trauma
排除标准
- •Subjects diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar I disorder, autism spectrum disorder, or intellectual disability based on DSM-
- •Subjects diagnosed with any mood disorder and anxiety disorder according to DSM-5 that is the primary focus of treatment in the last 6 months prior to screening, as per the clinical judgement of the investigator
- •Subjects who have completed two or more full courses of trauma-focused therapy in the past
结局指标
主要结局
Clinician-Administered PTSD Scale for DSM-5
时间窗: baseline and after intervention (up to 21 weeks)
The primary objective of this study is to assess the change from baseline of the Clinician Administered PTSD Scale (CAPS - 5) score. Scores range from 0 - 80, with higher scores indicating increased PTSD symptom severity.
次要结局
未报告次要终点
研究者
研究点 (66)
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