UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002828
Receipt number R000003449
Scientific Title A prognostic study of mentally disordered offender in the Medical Care and Supervision Act in Japan.
Date of disclosure of the study information 2009/12/02
Last modified on 2020/06/10 12:27:08

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Basic information

Public title

A prognostic study of mentally disordered offender in the Medical Care and Supervision Act in Japan.

Acronym

A prognostic study of mentally disordered offender in the Medical Care and Supervision Act in Japan.

Scientific Title

A prognostic study of mentally disordered offender in the Medical Care and Supervision Act in Japan.

Scientific Title:Acronym

A prognostic study of mentally disordered offender in the Medical Care and Supervision Act in Japan.

Region

Japan


Condition

Condition

mentally disordered offender under the Medical Care and Supervision Act

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to investivate the prognosis of mentally disorderd offenders following discharge and identify associated risk factors

Basic objectives2

Others

Basic objectives -Others

the same above

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the rate of reconviction, suicide, re-admission and the length of stay in our hospital

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 and Female

Key inclusion criteria

patients discharged from our forensic ward (only patients with their consent to this study)

Key exclusion criteria

none

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Naotsugu
Middle name
Last name Hirabayashi

Organization

National Center of Neurology and Psychiatry

Division name

Psychiatry

Zip code

1788551

Address

4-1-1 Ogawahigashi-machi, Kodaira-city, Tokyo

TEL

042-341-2711

Email

tnagata@ncnp.go.jp


Public contact

Name of contact person

1st name Naotsugu
Middle name
Last name Hirabayashi

Organization

National Center of Neurology and Psychiatry

Division name

psychiatry

Zip code

1788551

Address

4-1-1 Ogawahigashi-machi, Kodaira-city, Tokyo

TEL

042-341-2711

Homepage URL


Email

hirabaya@ncnp.go.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

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

National Center of Neurology and Psychiatry

Address

4-1-1 Ogawahigashi-machi, Kodaira-city, Tokyo

Tel

042-341-2711

Email

rinri-jimu@ncnp.go.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

国立病院機構花巻病院(岩手県)、国立病院機構さいがた病院(新潟県)、都立松沢病院(東京都)他


Other administrative information

Date of disclosure of the study information

2009 Year 12 Month 02 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

Completed

Date of protocol fixation

2009 Year 10 Month 27 Day

Date of IRB

2009 Year 09 Month 01 Day

Anticipated trial start date

2009 Year 10 Month 01 Day

Last follow-up date

2011 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete

2011 Year 03 Month 01 Day

Date analysis concluded

2011 Year 03 Month 31 Day


Other

Other related information

This study consists of prospective and retrospective parts: to investigate patients prognosis in prospective, and charactaristics from their medical sheets retrospectively. The ralation between two parts will be analyzed statistically.


Management information

Registered date

2009 Year 12 Month 02 Day

Last modified on

2020 Year 06 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003449


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name