UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039811
Receipt number R000045401
Scientific Title Analysis of risk factors and examination of biomarkers for recurrence in suicide attempts
Date of disclosure of the study information 2020/03/13
Last modified on 2024/03/06 16:39:28

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Basic information

Public title

Analysis of risk factors and examination of biomarkers for recurrence in suicide attempts

Acronym

Analysis of risk factors and examination of biomarkers for recurrence in suicide attempts

Scientific Title

Analysis of risk factors and examination of biomarkers for recurrence in suicide attempts

Scientific Title:Acronym

Analysis of risk factors and examination of biomarkers for recurrence in suicide attempts

Region

Japan


Condition

Condition

Drug intoxication

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze risk factors for relapse in suicide attempt patients transported by emergency and examine simple biomarkers

Basic objectives2

Others

Basic objectives -Others

To search for factors related to the status of taking psychotropic drugs as regular drugs and the suicide behavior

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

suicide attempt

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who were transported to the Advanced Critical Care and Emergency Center in Teikyo University Hospital for impaired consciousness caused by suicide attempt

Key exclusion criteria

Patients or family of whom expressed an intention to refuse to participate in this study

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Machiko
Middle name
Last name Watanabe

Organization

Faculty of Pharma-Science, Teikyo University

Division name

Laboratory of Clinical Pharmaceutics

Zip code

1738605

Address

2-11-1 Kaga Itabashi-ku, Tokyo

TEL

03-3964-1211

Email

wmachiko@pharm.teikyo-u.ac.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Hosono

Organization

Teikyo University Hospital

Division name

Center for Clinical Research & Trial

Zip code

1738606

Address

2-11-1 Kaga Itabashi-ku, Tokyo

TEL

03-3964-1211

Homepage URL

https://www.teikyo-u.ac.jp/affiliate/public_projects_202002_05.pdf

Email

hhosono@med.teikyo-u.ac.jp


Sponsor or person

Institute

Teikyo 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

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Teikyo University Review Board

Address

2-11-1 Kaga Itabashi-ku, Tokyo,173-8605

Tel

03-3964-7256

Email

turb-office@teikyo-u.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

帝京大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 13 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

661

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

Completed

Date of protocol fixation

2020 Year 02 Month 27 Day

Date of IRB

2020 Year 02 Month 27 Day

Anticipated trial start date

2020 Year 03 Month 13 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 03 Month 31 Day

Date trial data considered complete

2023 Year 03 Month 31 Day

Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information

observational research


Management information

Registered date

2020 Year 03 Month 13 Day

Last modified on

2024 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045401


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name