UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056333 |
|---|---|
| Receipt number | R000064344 |
| Scientific Title | Evaluation of the Clinical Usefulness of Measurement-Based and AI-Supported Care in the Treatment of Depression: An Open-Label Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/02/14 |
| Last modified on | 2025/02/13 09:13:20 |
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Basic information
Public title
Evaluation of the Clinical Usefulness of Measurement-Based and AI-Supported Care in the Treatment of Depression: An Open-Label Randomized Controlled Trial
Acronym
MBAIC Study
Scientific Title
Evaluation of the Clinical Usefulness of Measurement-Based and AI-Supported Care in the Treatment of Depression: An Open-Label Randomized Controlled Trial
Scientific Title:Acronym
MBAIC Study
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical usefulness of Measurement -Based and AI-supported care to the adult patients of major depressive disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Shared Decision Making Scale (SDM-Q-9 or SDM-Q-Doc) score and Client Satisfaction (CSQ-8J) at the time of end of intervention period
Key secondary outcomes
1. Coincident ratio between patient shared decision making (DSM-Q-9) and physician shared decision making (SDM-Q-Doc)
2. Remission rate of depression
3. Tool issues, frequency of tool use
4. Trust in physicians (TPS)
5. Depressive symptoms (HAMD, MADRS, BDI-II)
6. Satisfaction with the care using the tool (CSQ-8J)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Measurement -Based and AI-supported care along with usual care
Interventions/Control_2
Treatment as usual
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(Patients)
1. Those who meet the diagnostic criteria for depression in DSM-5
2. Those who understand the purpose and content of this study and have obtained written consent from the individual to participate in the study of their own free will
(Medical Doctors)
1. Outpatient doctors who are in charge of above patient
2. Those who understand the purpose and content of this study and have obtained written consent from the individual to participate in the study of their own free will
Key exclusion criteria
(Patients)
1. Those with a history of severe organic brain lesions or cognitive dysfunction
2. Those with a clinically diagnosed life-threatening or unstable physical condition at the time of screening
3. Those who are unable to visit the hospital more than twice within 3 months of participation in the study
4. Others deemed by the principal investigator to be ineligible for the study
(Medical Doctors)
N/A
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Kikuchi |
Organization
Keio University of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
t-kick.z3@keio.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Kikuchi |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
Homepage URL
t-kick.z3@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Himorogi Psychiatric Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211(ex62014)
med-rinri-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 | 02 | Month | 14 | 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
| 2025 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 02 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064344
