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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037486
Receipt No. R000042373
Scientific Title A Study of hormone levels in suicide attempted Male.
Date of disclosure of the study information 2019/07/25
Last modified on 2019/07/25

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Basic information
Public title A Study of hormone levels in suicide attempted Male.
Acronym A Study of hormone levels in suicide attempted Male.
Scientific Title A Study of hormone levels in suicide attempted Male.
Scientific Title:Acronym A Study of hormone levels in suicide attempted Male.
Region
Japan

Condition
Condition suicide attempt
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of hormone level in suicide attempted 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

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Target patients who meet all the following criteria
1) Male
2) Age: 20 years or older
3) Those who confirmed their intention to commit suicide by multiple consultations with a psychiatrist who is usually conducted when suicidal intention is suspected after entering the critical care and emergency center. In addition, judgment of the will of suicide is performed by clinical judgment.
Key exclusion criteria Patients who conflict with any of the following will not be included in this study
1) Those who refused to participate in this study
2) Others who are deemed inappropriate by the research director as a research subject
Target sample size 60

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
Email 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
Email hoda@takii.kmu.ac.jp

Sponsor
Institute Department of Neuropsychiatry, Kansai Medical University
Institute
Department

Funding Source
Organization Department of Neuropsychiatry, Kansai Medical University
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 Kansai Medical University
Address 10-15 Fumizono-cho, Moriguchi City, Osaka 570-8506, Japan
Tel 06-6992-1001
Email 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

Other administrative information
Date of disclosure of the study information
2019 Year 07 Month 25 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
2019 Year 07 Month 24 Day
Date of IRB
2019 Year 07 Month 23 Day
Anticipated trial start date
2019 Year 07 Month 24 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case-control study using existing information

Management information
Registered date
2019 Year 07 Month 25 Day
Last modified on
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042373

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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