UMIN-CTR Clinical Trial

Basic information
Public title	Prospective cohort study of patients with mental illness hospitalized compulsorily by prefectural governors.
Acronym	Prospective cohort study of patients with mental illness hospitalized compulsorily by prefectural governors.
Scientific Title	Prospective cohort study of patients with mental illness hospitalized compulsorily by prefectural governors.
Scientific Title:Acronym	Prospective cohort study of patients with mental illness hospitalized compulsorily by prefectural governors.
Region	Japan

Condition
Condition	Patients with mental illness hospitalized compulsorily by prefectural governors.
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the outcomes of patients hospitalized compulsorily by prefectural governors.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Personal and social performance scale (PSP) total score
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with mental illness hospitalized compulsorily by prefectural governors (in accordance with the provisions of Article 29 of the Mental Health Act)
Key exclusion criteria	None
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hidefumi Middle name Last name Seto
Organization	Fukuoka Prefectural Psychiatric Center Dazaifu Hospital
Division name	Psychiatry
Zip code	818-0125
Address	3-8-1 Gojo, Dazaifu-City, Fukuoka
TEL	092-922-3137
Email	setohidefumi@ybb.ne.jp

Public contact
Name of contact person	1st name Hidefumi Middle name Last name Seto
Organization	Fukuoka Prefectural Psychiatric Center Dazaifu Hospital
Division name	Psychiatry
Zip code	818-0125
Address	3-8-1 Gojo, Dazaifu-City, Fukuoka
TEL	092-922-3137
Homepage URL
Email	setohidefumi@ybb.ne.jp

Sponsor
Institute	Fukuoka Prefectural Psychiatric Center Dazaifu Hospital
Institute
Department

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	Aoyama Gakuin University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukuoka Prefectural Psychiatric Center Dazaifu Hospital
Address	3-8-1 Gojo, Dazaifu-City, Fukuoka
Tel	092-922-3137
Email	setohidefumi@dazaifu-hsp.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	長崎県精神医療センター（長崎県），国立病院機構肥前精神医療センター（佐賀県），宮城県立精神医療センター（宮城県），栃木県立岡本台病院（栃木県），石川県立高松病院（石川県），医療法人社団翠会八幡厚生病院（福岡県）、公益財団法人井之頭病院（東京都）、医療法人財団厚生協会大泉病院（東京都）、公益財団法人復康会沼津中央病院（静岡県）、岡山県精神科医療センター（岡山県）、国立病院機構琉球病院（沖縄県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 01 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	2016 Year 06 Month 01 Day
Date of IRB	2016 Year 04 Month 15 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is supported by the grant from the Japan Agency for Medical Research and Development (AMED).

Management information
Registered date	2016 Year 05 Month 27 Day
Last modified on	2021 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025876