UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057156 |
|---|---|
| Receipt number | R000065335 |
| Scientific Title | Research on biological, psychological, and sociological factors that predict refractoriness in major depressive disorder |
| Date of disclosure of the study information | 2025/02/27 |
| Last modified on | 2025/08/29 16:34:49 |
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Basic information
Public title
Research on biological, psychological, and sociological factors that predict refractoriness in major depressive disorder
Acronym
Predictors of refractoriness in major depressive disorder
Scientific Title
Research on biological, psychological, and sociological factors that predict refractoriness in major depressive disorder
Scientific Title:Acronym
Predictors of refractoriness in major depressive disorder
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to identify biological, psychological, and sociological factors that predict refractoriness in major depressive disorder.
Basic objectives2
Others
Basic objectives -Others
Basic exploratory study to explore the potential of biological, psychological, and sociological interventions for refractoriness in difficult-to-treat depression
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of biological, psychological, and sociological factors that predict refractoriness in major depressive disorder
Key secondary outcomes
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient
(1)18 years of age or older and 74 years of age or younger
(2)Diagnosis of Major Depressive Disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
(3)Observation period after the fixation of symptoms exceeds 6 months
(4)Outpatients or inpatients of the Department of Psychiatry at Jikei University Hospital, Jikei University Katsushika Medical Center, Jikei University Daisan Hospital, Jikei University Kashiwa Hospital, and Sobu Hospital
(5)Patients who can read and understand the informed consent form
Healthy subject
(1)18 years of age or older and 74 years of age or younger
(2)Individuals who can read and understand the informed consent form
Key exclusion criteria
Patient
(1)Patients who have difficulty voluntarily participating in research due to impaired judgment caused by psychiatric symptoms such as depressed mood, anxiety, agitation, and suicidal ideation
(2)Diagnosis of mental retardation, substance use disorder, or organic mental disorder
(3)Patients deemed inappropriate by the attending or responsible physician
Healthy subject
(1)Individuals with a history of psychiatric/neurological disorders, as identified by the research project member's review of background factors.
(2)Individuals with a history of psychotropic medication use identified by a research project member's review of background factors.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Mori |
Organization
The Jikei University School of Medicine
Division name
Department of Psychiatry
Zip code
105-8461
Address
3-25-8 Nishi-Shimbashi, Minato-Ku, Tokyo, Japan
TEL
03-3433-1111(3301)
h30d-mori@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Mori |
Organization
The Jikei University School of Medicine
Division name
Department of Psychiatry
Zip code
105-8461
Address
3-25-8 Nishi-Shimbashi, Minato-Ku, Tokyo, Japan
TEL
03-3433-1111(3301)
Homepage URL
h30d-mori@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Keisuke Mori
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jikei University Hospital
Jikei University KatsushikaMedical Center
Jikei University Daisan Hospital
Jikei University Kashiwa Hospital
Soubu Hospital, Fukkokai Foundation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Jikei University School of Medicine
Address
3-25-8 Nishi-Shimbashi, Minato-Ku, Tokyo, Japan
Tel
03-3433-1111(2134)
rinri@jikei.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 | 27 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multi-institutional, minimally invasive, prospective, observational study to collect samples and information from patients diagnosed with major depressive disorder and healthy controls at the Jikei University School of Medicine and collaborating institutions to identify biological, psychological, and sociological factors that predict refractoriness in major depressive disorder
Management information
Registered date
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065335
