UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063602 |
|---|---|
| Receipt number | R000072685 |
| Scientific Title | Usability Study of a Digital Therapeutic App for Patients with Major Depressive Disorder |
| Date of disclosure of the study information | 2026/11/12 |
| Last modified on | 2026/11/12 00:14:39 |
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Basic information
Public title
A Study to Evaluate the Usability of a Digital App for Treating Depression
Acronym
Depression App Usability Study
Scientific Title
Usability Study of a Digital Therapeutic App for Patients with Major Depressive Disorder
Scientific Title:Acronym
Digital Therapeutic App Usability Study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm that the Japanese-language user interface of a digital therapeutic app for patients with major depressive disorder can be used safely and appropriately by Japanese users and that use-related problems attributable to the user interface have been adequately reduced.
Basic objectives2
Others
Basic objectives -Others
Usability evaluation of the Japanese-translated and localized user interface
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Task performance during simulated use. Based on observation by study personnel, each task will be classified as Success, Difficulty, Use Error, or Not Attempted. Assessment will be conducted during each task.
Key secondary outcomes
1. Root causes of problems and participants' subjective feedback for tasks classified as Difficulty or Use Error, assessed through questions after the relevant task or after use.
2. Classification of the causes of observed use errors into Perception, Cognition, or Action.
3. Participants' perception and understanding of safety-related information and their ability to take appropriate action in anticipated scenarios, assessed within a single study session.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Japanese adults aged 18 years or older at the time of informed consent.
2.Able to communicate, read, and write in Japanese.
3.Regular users of an iOS or Android smartphone who are able to perform basic smartphone operations.
4.Able to provide written informed consent to participate in this study.
Key exclusion criteria
1.Individuals who have difficulty fully understanding the purpose or procedures of the study.
2.Individuals who have difficulty operating a smartphone or participating in the study throughout its duration.
3.Individuals with professional knowledge of or prior experience using this app or similar digital therapeutic apps for depression that may affect the usability evaluation.
4.Individuals otherwise considered unsuitable for participation by the study personnel.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Ohnishi |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Digital Business Office
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo, Japan
TEL
03-6717-1400
ohnishiko@otsuka.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Aizawa |
Organization
Uism KK
Division name
Research Department
Zip code
151-0053
Address
BizSmart 5F, 1-25-5 Yoyogi, Shibuya-ku, Tokyo, Japan
TEL
03-6869-3048
Homepage URL
naoto.aizawa@uism.co.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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3, Kichijoji-kitamachi, Musashino-shi, Tokyo, Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.com
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
STEP B-1ルーム
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 12 | 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
6
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study evaluates the usability of the Japanese-language digital therapeutic app for patients with major depressive disorder through simulated use by healthy adults.
Management information
Registered date
| 2026 | Year | 11 | Month | 12 | Day |
Last modified on
| 2026 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072685
