UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007968
Receipt number R000009382
Scientific Title Gender differences in psychosocial background of forensic inpatients under new legislation in Japan.
Date of disclosure of the study information 2012/05/16
Last modified on 2017/11/19 10:44:32

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Basic information

Public title

Gender differences in psychosocial background of forensic inpatients under new legislation in Japan.

Acronym

Gender differences in psychosocial background of forensic inpatients under new legislation in Japan.

Scientific Title

Gender differences in psychosocial background of forensic inpatients under new legislation in Japan.

Scientific Title:Acronym

Gender differences in psychosocial background of forensic inpatients under new legislation in Japan.

Region

Japan


Condition

Condition

Mental disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To survey of psychosocial characteristics and its differences of forensic male and female inpatients under new forensic legilation in Japan

Basic objectives2

Others

Basic objectives -Others

To understand of gender differences in psychosocial backgrounds of forensic patients

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

age, diagnosis, index offense, education, life history, medication history, and so on.

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

All inpatient with treatment order during July 15, 2005-March 1st, 2010, and admitted to the Forensic Ward in National Center of Neurology and Psychiatry (NCNP) hospital.

Key exclusion criteria

no exclusion criteria

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takako Nagata

Organization

National Center of Neurology and Psychiatry

Division name

Department of psychiatry

Zip code


Address

4-1-1, Ogawa-cho, Kodaira-city, Tokyo, Japan

TEL

042-341-2711

Email

tnagata@ncnp.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takako Nagata

Organization

National Center of Neurology and Psychiatry

Division name

Department of psychiatry

Zip code


Address

4-1-1, Ogawa-cho, Kodaira-city, Tokyo, Japan

TEL

042-341-2711

Homepage URL


Email

tnagata@ncnp.go.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



Funding Source

Organization

National Center of Neurology and Psychiatry

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2012 Year 05 Month 16 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


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

2005 Year 07 Month 15 Day

Date of IRB


Anticipated trial start date

2005 Year 07 Month 15 Day

Last follow-up date

2017 Year 11 Month 19 Day

Date of closure to data entry

2017 Year 11 Month 19 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

We will collect retrospectively data of forensic inpatients admitted to NCNP during July 15, 2007-March 1st, 2010 on expert's psychiatric examination reports and medical records.


Management information

Registered date

2012 Year 05 Month 16 Day

Last modified on

2017 Year 11 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009382


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name