JPRN-jRCTs032190089已完成1 期
Exploratory Research to Assess Usability of the Digital Medicine System (Proteus Digital Medicine Systems and Otsuka Medical Software) in Patients with Schizophrenia or Schizoaffective Disorder
Kishimoto Taishiro0 个研究点目标入组 30 人开始时间: 2019年9月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
In terms of efficacy, the primary endpoint, "Proportion of time when subjects wear their patches during the research period" was 93.21%. The secondary endpoint, "Proportion of time when subjects wear their patches during the research period by each visit" was 92.90% in the training period and 93.40% in the monotherapy period. In terms of safety, no deaths, serious adverse events, or other events requiring treatment with the investigational products occurred.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •1Clinical diagnosis of schizophrenia or schizoaffective disorder
- •2Male and female subjects 18 to 65 years of age
- •3Subjects must be willing and able to give written informed consent
- •4Outpatients who are visiting the research site
- •5Subjects are cooperative, able to ingest oral medication
- •6Subjects must be willing to use the DMS
- •7Subjects should own a smartphone for personal use that is available for this research
- •8Subjects must be willing to carry the smartphone on his/her person
- •9Subjects possess the capacity to utilize the technology interfaces
- •10Subjects must be willing to download and interact with the DMS app in a smartphone
排除标准
- •1Subjects who are planned or necessary to be admitted to a hospital
- •2Subjects who may desire to change their medication to a new treatment method or regimen during the research period to improve symptoms, and alleviate adverse drug reactions
研究者
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