UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049967 |
|---|---|
| Receipt number | R000056911 |
| Scientific Title | Multi-institutional clinical study of patients with major depressive disorder and healthy participants to examine the usefulness of the brain network marker program using fMRI for the diagnosis and stratification of major depressive disorder |
| Date of disclosure of the study information | 2023/03/24 |
| Last modified on | 2023/12/08 17:42:50 |
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Basic information
Public title
Multi-institutional clinical study of patients with major depressive disorder and healthy participants to examine the usefulness of the brain network marker program using fMRI for the diagnosis and stratification of major depressive disorder
Acronym
Multi-institutional clinical study to examine the usefulness of the brain network marker program using fMRI for the diagnosis of major depressive disorder
Scientific Title
Multi-institutional clinical study of patients with major depressive disorder and healthy participants to examine the usefulness of the brain network marker program using fMRI for the diagnosis and stratification of major depressive disorder
Scientific Title:Acronym
Multi-institutional clinical study to examine the usefulness of the brain network marker program using fMRI for the diagnosis of major depressive disorder
Region
| Japan |
Condition
Condition
Patients with major depressive disorder and healthy participants
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The usefulness of the "diagnostic brain network marker" and "stratification brain network marker" for major depressive disorder calculated from fMRI images by the AI program will be verified using clinical data anterogradely.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC of ROC curves in discriminating between depressed and healthy groups calculated using depression diagnostic brain network markers
Key secondary outcomes
-Diagnostic brain network markers for major depressive disorder evaluated longitudinally (0w, 6w, 6m).
-Depression severity (Hamilton Rating Scale for Depression) obtained longitudinally (0w, 6w) in the usual care group.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[Patients]
(1)Men and women aged between 20 and 75 at the time of consent acquisition.
(2)Patients with major depressive disorder using structured diagnostic interview measured after obtaining the consent.
(3)Patients who provide written and voluntary consent for participation in this study.
[Healthy participants]
(1)Men and women aged between 20 and 75 at the time of consent acquisition.
(2)Those whose psychiatric diagnostic interview results measured after obtaining consent are not psychiatric disorders.
(3)Participants who provide written and voluntary consent for participation in this study.
Key exclusion criteria
[Patients]
(1)Patients with mental status that makes it difficult to understand the purpose of the study.
(2)Patients who meet any of the following criteria:
-Patients with depression with psychotic features.
-Patients who have been diagnosed with bipolar disorder or schizophrenia using DSM.
-Patients who have been diagnosed with substance abuse within 6 months prior to obtaining consent.
-Patients who have been treated for an anxiety disorder within 6 months prior to obtaining consent.
-Patient who have a comorbid personality disorder at the time of consent acquisition.
(3)Patients with significant suicidal tendencies.
(4)Patients with contraindications to MRI.
(5)Patients who are deemed inappropriate as research participants by the principal investigator or a subinvestigator.
[Healthy participants]
(1)Participants with current or history of psychiatric or neurological disorders.
(2)Participants with contraindications to MRI.
(3)Participants who are deemed inappropriate as research participants by the principal investigator or a subinvestigator.
Target sample size
520
Research contact person
Name of lead principal investigator
| 1st name | Hidehiko |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Medical and Dental University
Division name
Department of Psychiatry and Behavioral Sciences
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5238
hidepsyc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Fujino |
Organization
Tokyo Medical and Dental University
Division name
Department of Psychiatry and Behavioral Sciences
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5238
Homepage URL
jf15psyc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental 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
Tokyo Medical and Dental University Ethics Review Committee, School of Medicine
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-3813-6111
syomu1.adm@tmd.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
東京医科歯科大学病院（東京都）、東京大学医学部附属病院(東京都）、昭和大学発達障害医療研究所（東京都）、慶應義塾大学病院（東京都）、国立精神・神経医療研究センター病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 24 | 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
| 2023 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational Study
Management information
Registered date
| 2023 | Year | 01 | Month | 05 | Day |
Last modified on
| 2023 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056911
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