UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060084 |
|---|---|
| Receipt number | R000068696 |
| Scientific Title | Development and Application of Treatment Optimization Technology Based on Depression Diagnosis and Stratification Markers |
| Date of disclosure of the study information | 2025/12/26 |
| Last modified on | 2025/12/12 15:20:28 |
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Basic information
Public title
Development and Application of Treatment Optimization Technology Based on Depression Diagnosis and Stratification Markers
Acronym
Development and Application of Treatment Optimization Technology Based on Depression Diagnosis and Stratification Markers
Scientific Title
Development and Application of Treatment Optimization Technology Based on Depression Diagnosis and Stratification Markers
Scientific Title:Acronym
Development and Application of Treatment Optimization Technology Based on Depression Diagnosis and Stratification Markers
Region
| Japan |
Condition
Condition
Mental disorders and healthy control
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose of this study: The study will target participants in an existing dataset, the "Longitudinal MRI study to elucidate the neural circuit substrates associated with remission and recovery in mood disorders (commonly known as the L/R study)." The study will apply the "Depression Diagnostic and Stratification Brain Circuit Marker Program" to the acquired brain images. The aim is to evaluate the diagnostic brain circuit markers of participants in the L/R study and classify them into multiple depression subtypes, thereby clarifying the differences in treatment effects between standard treatments (pharmacotherapy, CBT, ECT, and rTMS) for each subtype. The data obtained during this verification process will also be used as training data to improve the accuracy of the program.
Significance of this study: In clinical practice, there are no indicators that enable objective diagnosis, or methods that allow for the prediction and direct comparison of treatment effects and remission for various highly needed treatments.
Some of the results obtained in this study regarding the "Depression Diagnostic Brain Circuit Marker Program" and the "Depression Stratification Brain Circuit Marker Program" may be used in future approval applications.
It is believed that by using the "Depression Diagnostic Brain Circuit Marker Program" to distinguish depressed cases from healthy cases using MRI images, it will be possible to diagnose depression based on objective evidence.
Similarly, by classifying depressed cases into multiple subtypes using MRI images and clarifying the differences in treatment effects when each subtype receives the four main treatments, it is believed that it will be possible to select individualized treatments for depression.
This research will have a major impact on the clinical practice of depression, and the above is its significance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Endpoints (and their measures/evaluation methods): Evaluate the diagnostic performance for depression in the L/R study and assess differences in treatment efficacy among standard therapies (pharmacotherapy, CBT, ECT, rTMS) for each depression subtype.
Regarding diagnostic performance for depression, diagnostic indices will be calculated using pre-existing programs applied to data from depressed patients and healthy controls. Diagnostic performance will be evaluated using indices such as AUC of the ROC curve, sensitivity, specificity, and discrimination rate based on the diagnostic indices for both groups.
For depression subtypes, pre-existing programs will also be used to classify depression patient data into subtypes. Subsequently, longitudinal treatment data will be used to evaluate treatment responsiveness for each subtype.
Secondary evaluation items (and their metrics/evaluation methods): Since the characteristics of groups receiving each treatment intervention may differ, we will evaluate diagnostic metric values and subtype classification rates among standard treatments (pharmacotherapy, CBT, ECT, rTMS) in the L/R study.
For the depression group, we will calculate diagnostic indicators and subtypes using the pre-established program. Comparing these across standard treatments (pharmacotherapy, CBT, ECT, rTMS) will clarify the characteristics of each group.
Exploratory evaluation items (and their indicators/evaluation methods): We will explore the relationship between depression diagnostic indicators and depression subtypes, as well as the relationship between depression diagnostic indicators/subtypes and clinical characteristics.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants aged 20 years or older (both depressed and healthy) from the existing dataset, "Longitudinal MRI study to elucidate neural circuit mechanisms associated with remission and recovery in mood disorders (commonly known as the L/R study)."
Key exclusion criteria
This study is an analytical study using an existing dataset, and will exclude
1. cases with insufficient medical information
2. cases who have expressed their intention not to participate through the opt-out process described below
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Jinichi |
| Middle name | |
| Last name | Hirano |
Organization
Keio University
Division name
School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3971
hjinichi@keio.jp
Public contact
Name of contact person
| 1st name | Jinichi |
| Middle name | |
| Last name | Hirano |
Organization
Keio University
Division name
School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3971
Homepage URL
hjinichi@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
XNef, Inc.
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
Keio University
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
Tel
03-5363-3503
med-nintei-jimu@adst.keio.ac.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
| 2025 | Year | 12 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 12 | Month | 15 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068696
