UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037486
Receipt number 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 15:22:11

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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 or person

Institute

Department of Neuropsychiatry, Kansai Medical University

Institute

Department

Personal name



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

Value
https://center6.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