UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053472 |
|---|---|
| Receipt number | R000061032 |
| Scientific Title | A Retrospective Study of Factors Associated with Suicide Attempts in Psychiatric Emergencies |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/02/02 15:45:16 |
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Basic information
Public title
A Retrospective Study of Factors Associated with Suicide Attempts in Psychiatric Emergencies
Acronym
A Retrospective Study of Factors Associated with Suicide Attempts in Psychiatric Emergencies
Scientific Title
A Retrospective Study of Factors Associated with Suicide Attempts in Psychiatric Emergencies
Scientific Title:Acronym
FASAPE study
Region
| Japan |
Condition
Condition
suicide attempts
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare the absolute risk group and relative risk group in suicide attempts in emergency psychiatric care at Iwate Medical University Hospital, and examine the factors associated with the appearance of the absolute risk group by multivariate analysis to clarify the risk factors for the occurrence of severe physical suicide attempts.
Basic objectives2
Others
Basic objectives -Others
Physically severe suicide attempts are a population similar to suicide attempters and are more likely to attempt suicide again. However, the factors associated with suicide attempts and risk factors for the occurrence of severe physical suicide attempts have not been fully identified. In this study, we aimed to investigate and identify suicide-related factors such as motive, means, and severity of suicide attempts, in addition to psychiatric symptoms and outcome, in suicide attempts who required emergency psychiatric care at Iwate Medical University Hospital.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical endpoints-such as age, gender, diagnosis, outcome, and treatment-of severe physical suicide attempts, will be used as primary outcomes, and tested for significant differences.
Key secondary outcomes
We will stratify the identified items for the presence of significant differences, and perform multivariate analysis to determine the factors associated with physically severe suicide attempts.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited the primary and secondary emergency outpatient clinics of Iwate Medical University Hospital and the Iwate Advanced Emergency Medical Center between January 1, 2003 and March 31, 2022, and were treated as emergency psychiatric cases by our psychiatrists, who met the diagnostic criteria for suicide attempts.
Key exclusion criteria
When a patient or his/her surrogate in the case of a minor requests refusal to participate in the research by opting out.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Otsuka |
Organization
Iwate Medical University
Division name
Department of Neuropsychiatry
Zip code
028-3694
Address
1-1-1, Idaidori, Yahaba, Shiwa, Iwate
TEL
+81-19-651-5111
psychiat.iwate.imu@gmail.com
Public contact
Name of contact person
| 1st name | Takaomi |
| Middle name | |
| Last name | Abe |
Organization
Iwate Medical University
Division name
Department of Neuropsychiatry
Zip code
028-3694
Address
1-1-1, Idaidori, Yahaba, Shiwa, Iwate
TEL
+81-19-651-5111
Homepage URL
psychiat.iwate.imu@gmail.com
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Kotaro Otsuka
Funding Source
Organization
None
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
Ethics Committee of Iwate Medical University School of Medicine
Address
1-1-1, Idaidori, Yahaba, Shiwa, Iwate
Tel
+81-19-651-5111
kenkyu-rinri@j.iwate-med.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
| 2024 | Year | 02 | 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
4624
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 17 | 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
This is a non-invasive, backward-looking study using information on patients who visited the emergency department of our hospital. Patients who fulfilled the Kishi's diagnostic criteria for suicide attempts were included in the study. Patients were divided into two groups; an absolute risk group and a relative risk group for severe physical suicide attempts according to Asukai's criteria, and the two groups were compared. We will also examine the factors associated with the occurrence of the absolute risk group using multivariate analysis to identify the risk factors for the occurrence of physically severe suicide attempts.
Management information
Registered date
| 2024 | Year | 01 | Month | 29 | Day |
Last modified on
| 2024 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061032
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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