UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045404
Receipt number R000051847
Scientific Title Suicide and unemployment rate: nationwide survey in Japan
Date of disclosure of the study information 2021/09/07
Last modified on 2022/11/18 16:12:10

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Basic information

Public title

Suicide and unemployment rate: nationwide survey in Japan

Acronym

Suicide and unemployment rate: nationwide survey in Japan

Scientific Title

Suicide and unemployment rate: nationwide survey in Japan

Scientific Title:Acronym

Suicide and unemployment rate: nationwide survey in Japan

Region

Japan


Condition

Condition

Suicide

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will re-evaluate the influence of the COVID-19 pandemic on the suicide incidence in Japan using nationwide data provided from the government.

Basic objectives2

Others

Basic objectives -Others

In addition, we will analyze how unemployment rate confounded suicide incidence.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Monthly suicide incidence.
Spearman's rank correlation coefficient and determination of coefficient will be assessed between suicide incidence and unemployment rate.

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

All residents in Japan including both sexes.

Key exclusion criteria

Not set.

Target sample size

128000000


Research contact person

Name of lead principal investigator

1st name Nobuyuki
Middle name
Last name Horita

Organization

Yokohama City University Hospital

Division name

Chemotherapy Center

Zip code

236-0004

Address

3-9, Fukuura, Kanazawa

TEL

0081-45-787-2800

Email

horitano@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Nobuyuki
Middle name
Last name Horita

Organization

Yokohama City University Hospital

Division name

Chemotherapy Center

Zip code

236-0004

Address

3-9, Fukuura, Kanazawa

TEL

0081-45-787-2800

Homepage URL


Email

horitano@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University Hospital

Institute

Department

Personal name



Funding Source

Organization

Yokohama City University Hospital

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

Yokohama City University Hospital

Address

3-9, Kanazawa, Fukuura, Yokohama

Tel

0081-45-787-2800

Email

horitano@yokohama-cu.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

2021 Year 09 Month 07 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8965634/

Number of participants that the trial has enrolled

120000000

Results

In the gender-stratified analysis of all ages, the incidence of suicide was higher than the estimation by 17.0% (95% CI, 11.4%-22.7%; Pā€‰<ā€‰.001) for men and 31.0% (95% CI, 22.8%-39.2%; Pā€‰<ā€‰.001) for women.

Results date posted

2022 Year 11 Month 18 Day

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

Main results already published

Date of protocol fixation

2021 Year 09 Month 07 Day

Date of IRB

2021 Year 09 Month 07 Day

Anticipated trial start date

2021 Year 09 Month 07 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

[Data access]
Population size will be provided from the Statistics Bureau of Japan.
Number of cause-specified death cases compiled by the Ministry of Health, Labor and Welfare will be provided from the Statistics Bureau of Japan.
Number of suicide cases compiled by the National Police Agency will be obtained through the National Police Agency will be provided from the Statistics Bureau of Japan.
Unemployment rate will be provided from the Statistics Bureau of Japan.

[Interrupted time series analysis]
Firstly, monthly suicide incidence will be calculated. Then, interrupted time series analysis will be conducted following the following methodology.
Kontopantelis E, et al. Regression based quasi-experimental approach when randomisation is not an option: interrupted time series analysis. BMJ 2015; 350: h2750.
Penfold RB, et al. Use of interrupted time series analysis in evaluating health care quality improvements. Acad Pediatr 2013; 13(6 Suppl): S38-44.
Wagner AK, et al. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther 2002; 27(4): 299-309.

[General statistical approach]
Spearman's rank correlation coefficient and determination of coefficient will be assessed between suicide incidence and unemployment rate.
Statistical significance threshold will be set at 0.05.
Bonferroni correction will be used as appropriate.
All the statistical analyses will be conducted by BellCurve for Excel (SSRI, Tokyo, Japan).
Additional descriptive analysis will be conducted as appropriate.


Management information

Registered date

2021 Year 09 Month 07 Day

Last modified on

2022 Year 11 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051847


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name