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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029208
Receipt No. 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 2017/09/20

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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
Middle name
Last name Hiroyuki Oda
Organization Kansai Medical University
Division name Department of Neuropsychiatry
Zip code
Address 10-15 Fumizono-cho, Moriguchi City, Osaka 570-8506, Japan
TEL 06-6992-1001
Email hoda@takii.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Oda
Organization Kansai Medical University
Division name Department of Neuropsychiatry
Zip code
Address 10-15 Fumizono-cho, Moriguchi City, Osaka 570-8506, Japan
TEL 06-6992-1001
Homepage URL
Email hoda@takii.kmu.ac.jp

Sponsor
Institute Department of Neuropsychiatry, Kansai Medical University
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2017 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 20 Day
Last modified on
2017 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032178

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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