Exploratory Research to Assess Usability of the Digital Medicine System in Patients with Schizophrenia or Schizoaffective Disorder

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032190089

Enrollment

Registered

2019-09-02

Start date

2020-09-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, schizoaffective disorder Schizophrenia

Interventions

Independent phase during the second part of the treatment period: 5 weeks At Week 3 onward, whether the subject can use the system with minimum assistance of HCPs will be evaluated.

Digital Medicine System

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Proportion of time when subjects wear their patches during the research period	—

Secondary

Measure	Time frame
1Proportion of time when subjects wear their patches during the research period by each visit 2Duration and proportion of time when subjects wear their patches successfully during the research period 3Proportion of subjects being able to apply the patch independently and successfully, and synchronize it with the application 4Time to the first occurrence of the subject being able to apply the patch independently and successfully, and synchronize it with the application, and cumulative proportion of such subjects 5Proportion of subjects being able to apply the patch successfully, and synchronize it with the application with minimum assistance 6Time to the first occurrence of the subject being able to apply the patch successfully, and synchronize it with the application with minimum assistance, and cumulative proportion of such subjects 7Perceived usability and levels of satisfaction with the DMS assessed by subjects and HCPs 8Number and proportion of days subjects are using the application during the research period 9Number and proportion of days when HCPs are using the healthcare professional portal during the research period 10Frequency of Call Center support to subjects and HCPs in total and by help type 11Number of patches which subjects wear during the research period 12Number of MITs ingested by the subject, number of ingested MITs registered on the digital health data server, and number of days when subjects wear their patches registered on the digital health data server 13Mean change from baseline to Week 8 (or early termination) in CGI-S 14Mean change from baseline to Week 8 (or early termination) in BPRS 15MIT signal detection rate at the initiation and at Week 8/early termination	—

Measure

Time frame

1Proportion of time when subjects wear their patches during the research period by each visit 2Duration and proportion of time when subjects wear their patches successfully during the research period 3Proportion of subjects being able to apply the patch independently and successfully, and synchronize it with the application 4Time to the first occurrence of the subject being able to apply the patch independently and successfully, and synchronize it with the application, and cumulative proportion of such subjects 5Proportion of subjects being able to apply the patch successfully, and synchronize it with the application with minimum assistance 6Time to the first occurrence of the subject being able to apply the patch successfully, and synchronize it with the application with minimum assistance, and cumulative proportion of such subjects 7Perceived usability and levels of satisfaction with the DMS assessed by subjects and HCPs 8Number and proportion of days subjects are using the application during the research period 9Number and proportion of days when HCPs are using the healthcare professional portal during the research period 10Frequency of Call Center support to subjects and HCPs in total and by help type 11Number of patches which subjects wear during the research period 12Number of MITs ingested by the subject, number of ingested MITs registered on the digital health data server, and number of days when subjects wear their patches registered on the digital health data server 13Mean change from baseline to Week 8 (or early termination) in CGI-S 14Mean change from baseline to Week 8 (or early termination) in BPRS 15MIT signal detection rate at the initiation and at Week 8/early termination

—

Contacts

Public ContactHideki Oi

National Center of Neurology and Psychiatry

oih@ncnp.go.jp+81-42-341-2711

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026