UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060436 |
|---|---|
| Receipt number | R000069141 |
| Scientific Title | An Observational Study Using Wearable Devices for the Exploration of Digital Biomarkers in Psychiatric Disorders |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/01/22 10:51:46 |
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Basic information
Public title
An Observational Study Using Wearable Devices for the Exploration of Digital Biomarkers in Psychiatric Disorders
Acronym
An Observational Study Using Wearable Devices for the Exploration of Digital Biomarkers in Psychiatric Disorders
Scientific Title
An Observational Study Using Wearable Devices for the Exploration of Digital Biomarkers in Psychiatric Disorders
Scientific Title:Acronym
An Observational Study Using Wearable Devices for the Exploration of Digital Biomarkers in Psychiatric Disorders
Region
| Japan |
Condition
Condition
Psychiatric Disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore and characterize digital biomarkers associated with psychiatric disorders by using data for wearable devices in patients and healthy controls, and to compare findings across disorders.
Basic objectives2
Others
Basic objectives -Others
Not applicable (exploratory analyses only)
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
None prespecified (exploratory analyses only)
Key secondary outcomes
None; exploratory analyses only.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
<for patients>
1) Participants who are eighteen years of age or older and younger than seventy years of age at the time of screening
2) Participants who are diagnosed with the relevant psychiatric disorder according to the DSM-5 diagnostic criteria
<for healthy controls>
1) Participants who are eighteen years of age or older and younger than seventy years of age at the time of screening
Key exclusion criteria
<for patients>
1) Participants for whom the investigator determines at screening that completion of the study is not feasible.
<for healthy controls>
1) Participants with a current or past history of psychiatric disorders.
2) Participants for whom the investigator determines at screening that completion of the study is not feasible.
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Nakagome |
Organization
National Center of Neurology and Psychiatry
Division name
President
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi-machi, Kodaira-shi, Tokyo, Japan
TEL
042-341-2711
nakagome@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Furukawa |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
HQ of Clinical Development
Zip code
108-8242
Address
Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Homepage URL
Furukawa.Megumi@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi-machi, Kodaira-shi, Tokyo, Japan
Tel
042-341-2711
rinri-jimu@ncnp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study using wearable devices to explore digital biomarkers associated with psychiatric disorders. The study aims to identify candidate digital biomarkers by analyzing clinical data and wearable device-derived digital data collected from patients with psychiatric disorders and healthy controls. No primary endpoint is defined in this study. Exploratory analyses, including correlation analyses to evaluate the relationships between clinical and digital measures, will be conducted.
Management information
Registered date
| 2026 | Year | 01 | Month | 22 | Day |
Last modified on
| 2026 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069141
