UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035912
Receipt number R000040913
Scientific Title A study of grey-zone model of patients with mental disorders: Phase 2
Date of disclosure of the study information 2019/02/18
Last modified on 2022/03/14 15:11:06

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Basic information

Public title

A study of grey-zone model of patients with mental disorders: Phase 2

Acronym

Grey-zone model study in psychiatry: Phase 2

Scientific Title

A study of grey-zone model of patients with mental disorders: Phase 2

Scientific Title:Acronym

Grey-zone model study in psychiatry: Phase 2

Region

Japan


Condition

Condition

All mental disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the validity of "grey-zone models in psychiatry" and gather the opinion of designated psychiatrists about the models.

Basic objectives2

Others

Basic objectives -Others

The subject of this study is not patients.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Not applicable

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

Designated psychiatrists in Japan
Patients with mental disorders
Lawyers engaging in the field of mental health

Key exclusion criteria

adult ward or person under curatorship
incompetent to give an informed consent
participants in the previous study
inpatient in a psychiatric hospital
risk of any disadvantages due to participation

Target sample size

1012


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Shiina

Organization

Chiba University Center for Forensic Mental Health

Division name

Division of Medical Treatment and Rehabilitation

Zip code

2608670

Address

Inohana 1-8-1, Chuoh-ku, Chiba-shi

TEL

81432227171

Email

shiina-akihiro@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Shiina

Organization

Chiba University Center for Forensic Mental Health

Division name

Division of Medical Treatment and Rehabilitation

Zip code

2608670

Address

Inohana 1-8-1, Chuoh-ku, Chiba-shi

TEL

81432227171

Homepage URL


Email

shiina-akihiro@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba University Center for Forensic Mental Health

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



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba University Graduate School of Medicine

Address

Inohana 1-8-1, Chuo-ku, Chiba-shi

Tel

81432227171

Email

igaku-rinri@office.chiba-u.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

2019 Year 02 Month 18 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

460

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

2018 Year 12 Month 14 Day

Date of IRB

2018 Year 11 Month 15 Day

Anticipated trial start date

2019 Year 01 Month 09 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We will make a questionnaire survey to designated psychiatrists about "grey-zone models" created in the previous study. As well, we will conduct an interview with patients, family members, and lawyers for gathering the opinions toward the models.


Management information

Registered date

2019 Year 02 Month 18 Day

Last modified on

2022 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040913


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name