Exploratory Research to Assess Usability of the Digital Medicine System in Patients with Schizophrenia or Schizoaffective Disorder
- Conditions
- Schizophrenia, schizoaffective disorderSchizophrenia
- Registration Number
- JPRN-jRCTs032190089
- Lead Sponsor
- Kishimoto Taishiro
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of time when subjects wear their patches during the research period
- Secondary Outcome Measures
Name Time Method