UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022500 |
|---|---|
| Receipt number | R000025876 |
| Scientific Title | Prospective cohort study of patients with mental illness hospitalized compulsorily by prefectural governors. |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2021/11/17 13:11:00 |
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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
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
setohidefumi@ybb.ne.jp
Sponsor or person
Institute
Fukuoka Prefectural Psychiatric Center Dazaifu Hospital
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025876
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
