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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002828
Receipt No. 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 2019/06/10

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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
Institute National Center of Neurology and Psychiatry
Institute
Department

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 Enrolling by invitation
Date of protocol fixation
2009 Year 10 Month 27 Day
Date of IRB
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
2019 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.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


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