UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059466 |
|---|---|
| Receipt number | R000067998 |
| Scientific Title | The Clinical Features and Underlying Neural Mechanisms of Late-Life Depression |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/18 22:33:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Clinical Features and Underlying Neural Mechanisms of Late-Life Depression
Acronym
CNLLD
Scientific Title
The Clinical Features and Underlying Neural Mechanisms of Late-Life Depression
Scientific Title:Acronym
CNLLD
Region
| Japan |
Condition
Condition
Late-Life Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to clarify the clinical manifestations and neurological differences based on the age of onset in late-life depression (LLD).
Basic objectives2
Others
Basic objectives -Others
Exploration of clinical manifestations and neurological differences.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differentiations in cognitive function, biological response indicators and brain structure.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Individuals diagnosed with Major Depressive Disorder, either outpatients or inpatients in Keio University hospital.
2.Individuals 60 years of age or older at the time of informed consent.
3.Individuals who are clinically free of any overt neurodegenerative disorder at the time of informed consent.
4.Individuals who are capable of providing written informed consent for this study.
Key exclusion criteria
1.Individuals with co-morbid disorders that are determined to be severe or significantly unstable.
2.Individuals with a history of head trauma or substance dependence.
3.Individuals with a pacemaker or other metallic implants.
4.Individuals with current or a history of epilepsy or generalized seizures.
5.Individuals judged as unsuitable for participation in this study by the investigators for any other reason.
Target sample size
200
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
TEL
03-3353-1211
hjinichi@keio.jp
Public contact
Name of contact person
| 1st name | Jinichi |
| Middle name | |
| Last name | Hirano |
Organization
Department of Neuropsychiatry
Division name
School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
hjinichi@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
The Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office of Clinical Research
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
ocr@crea.hosp.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 | 11 | Month | 01 | 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
Suspended
Date of protocol fixation
| 2023 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special notes
Management information
Registered date
| 2025 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067998
