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. Japan35 个研究点分布在 1 个国家目标入组 52 人2024年9月1日

适应症Post-Traumatic Stress Disorder, PTSD

概览

阶段: 2 期
干预措施: 未指定
疾病 / 适应症: Post-Traumatic Stress Disorder, PTSD
发起方: Otsuka Medical Devices Co., Ltd. Japan
入组人数: 52
试验地点: 35
主要终点: Clinician-Administered PTSD Scale for DSM-5
状态: 招募中
最后更新: 5个月前

概览研究者入排标准结局指标研究点相似试验

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)

注册库

clinicaltrials.gov

开始日期

2024年9月1日

结束日期

2028年1月31日

最后更新

5个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Otsuka Medical Devices Co., Ltd. Japan

责任方

Sponsor

入排标准

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.