UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029208 |
|---|---|
| Receipt number | R000032178 |
| Scientific Title | A Study on Relationship between Suicide Attempted Male and LOH Syndrome. |
| Date of disclosure of the study information | 2017/09/20 |
| Last modified on | 2019/09/26 15:53:29 |
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Basic information
Public title
A Study on Relationship between Suicide Attempted Male and LOH Syndrome.
Acronym
A Study on Relationship between Suicide Attempted Male and LOH Syndrome.
Scientific Title
A Study on Relationship between Suicide Attempted Male and LOH Syndrome.
Scientific Title:Acronym
A Study on Relationship between Suicide Attempted Male and LOH Syndrome.
Region
| Japan |
Condition
Condition
suicide attempt
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of testosterone level in suicide attempt male
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
testosterone lebel
Key secondary outcomes
AMS(aging males' symptoms)
BDI(Beck Depression Inventory)
M.I.N.I.(Mini-International Neuropsychiatric Interview)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Participants were evaluated by testosterone lebel, AMS, BDI, M.I.N.I..
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
| Not applicable |
Gender
Male
Key inclusion criteria
Suicide attempt.
Participants provided written informed consent to participate in this study.
Key exclusion criteria
Disturbance of consciousness.
Participants who do not understand Japanese.
Participants who have ineligible reasons.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Oda |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry
Zip code
570-8506
Address
10-15 Fumizono-cho, Moriguchi City, Osaka 570-8506, Japan
TEL
06-6992-1001
hoda@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Oda |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry
Zip code
570-8506
Address
10-15 Fumizono-cho, Moriguchi City, Osaka 570-8506, Japan
TEL
06-6992-1001
Homepage URL
hoda@takii.kmu.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
10-15 Fumizono-cho, Moriguchi City, Osaka, Japan
Tel
06-6992-1001
kmuinfo@hirakata.kmu.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
関西医科大学総合医療センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 20 | 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
| 2017 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 20 | Day |
Last modified on
| 2019 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032178
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
