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
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
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
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
