UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042716 |
|---|---|
| Receipt number | R000048724 |
| Scientific Title | Unzen Fugendake eruption disaster stress medical record survey on the relationship between long-term course and emotional disorders in old age and dementia |
| Date of disclosure of the study information | 2020/12/15 |
| Last modified on | 2025/12/16 19:06:03 |
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Basic information
Public title
Unzen Fugendake eruption disaster stress medical record survey on the relationship between long-term course and emotional disorders in old age and dementia
Acronym
Unzen Fugendake eruption disaster stress medical record survey on the relationship between long-term course and emotional disorders in old age and dementia
Scientific Title
Unzen Fugendake eruption disaster stress medical record survey on the relationship between long-term course and emotional disorders in old age and dementia
Scientific Title:Acronym
Unzen Fugendake eruption disaster stress medical record survey on the relationship between long-term course and emotional disorders in old age and dementia
Region
| Japan |
Condition
Condition
Depression, Dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Based on data records, we will investigate the effects of the Unzen Fugendake eruption disaster on the onset and progression of depression or dementia who are 60 years old or older and are currently in the hospital or outpatient clinic.
Basic objectives2
Others
Basic objectives -Others
Status of onset and current treatment
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
GAF scale
Key secondary outcomes
Current treatment content
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
Outpatients or inpatients with consent during the survey period
Key exclusion criteria
Those who cannot agree (those who cannot obtain proxy consent)
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hirohisa |
| Middle name | |
| Last name | Kinoshita |
Organization
Nagasaki University
Division name
Center for Health and Community Medicine
Zip code
852-8521
Address
1-14 Bunkyou,Nagasaki,852-8521,Japan
TEL
095-819-2212
nus-kino@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirohisa |
| Middle name | |
| Last name | Kinoshita |
Organization
Nagasaki University
Division name
Center for Health and Community Medicine
Zip code
852-8521
Address
1-14 Bunkyou,Nagasaki,852-8521,Japan
TEL
095-819-2212
Homepage URL
nus-kino@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Nagasaki University Graduate School of Biomedical Sciences
Address
1-12-4,Sakamoto,Nagasaki,852-8523,Japan
Tel
0958197198
gakujutu_gakuji@ml.nagasaki-u.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
| 2020 | Year | 12 | Month | 15 | 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
The plan has not yet been implemented due to the impact of the spread of the new coronavirus infection.
We are currently considering changes to our research plan.
Results date posted
| 2022 | Year | 06 | Month | 30 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The plan has not yet been implemented due to the impact of the spread of the new coronavirus infection.
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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 15 | Day |
Other
Other related information
Investigate the effects of the Unzen Fugendake eruption disaster on the onset and progression of depression and dementia. Investigate whether there is a difference in impact depending on the region.
Due to the continuing impact of the spread of coronavirus infections, as of January 2023, the survey could not be started.
From January 2024, patient enrollment began and continued through March, resulting in 120 participants.
Of these, 119 cases were analyzed to investigate the presence or absence of disaster experience and its impact on the long-term course of dementia and depression. Statistically, no significant difference was observed between the presence or absence of disaster experience and its effect on dementia or depression.
These results were presented at the 43rd Annual Meeting of the Japanese Society of Psychiatric Diagnosis (Kobe) on September 21, 2024.
The study will be concluded on December 15,2025
Management information
Registered date
| 2020 | Year | 12 | Month | 10 | Day |
Last modified on
| 2025 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048724
