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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000444
Receipt No. R000000539
Scientific Title A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)
Date of disclosure of the study information 2006/07/04
Last modified on 2013/10/30

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Basic information
Public title A Randomized Controlled Multicenter Trial of Post-Suicide Attempt
Case Management for the Prevention of Further Attempts in Japan
(ACTION-J)
Acronym A Randomized Controlled Multicenter Trial of Post-Suicide Attempt
Case Management for the Prevention of Further Attempts in Japan
(ACTION-J)
Scientific Title A Randomized Controlled Multicenter Trial of Post-Suicide Attempt
Case Management for the Prevention of Further Attempts in Japan
(ACTION-J)
Scientific Title:Acronym A Randomized Controlled Multicenter Trial of Post-Suicide Attempt
Case Management for the Prevention of Further Attempts in Japan
(ACTION-J)
Region
Japan

Condition
Condition suicide attempts
Classification by specialty
Psychiatry Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Incidence of first recurrent suicidal behavior
Key secondary outcomes *Any cause of death
*Repeated recurrent incidence of suicide attempts
*Number of self-injury
*Utilization or personal or social resources
*Health care utilization
*Physical function
*Beck hopeless scale
*SF-36
*Adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Case management
Usual clinical practice
Providing paper based information for suicide prevention
Interventions/Control_2 Usual clinical practice
Providing paper based information for suicide prevention
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 1.Over 20 years old
2.Suffering from Axis I disorder
3.Had intent for suicide (confirmed more than 2 times)
4.Able to understand this study and provide informed consent
5.Able to have interview before trial registry and psycho education at hospital
6. Able to have interview for assess
ment at continuous follow-up care by case manager at the hospital
Key exclusion criteria Not suffering from Axis I disorder as a primary diagnosis
Target sample size 914

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Hirayasu
Organization Yokohama City University
Division name Department of psychiatry, School of medicine
Zip code
Address 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, Japan
TEL 042-341-2711
Email hirayasu@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chiaki Kawanishi
Organization Yokohama City University
Division name Department of psychiatry, School of medicine
Zip code
Address 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, Japan
TEL 042-341-2711
Homepage URL http://www.jfnm.or.jp/itaku/J-MISP/index.html
Email sp_ycu@yokohama-cu.ac.jp

Sponsor
Institute Health Labour Sciences Research Grant
Research on Psychiatric and Neurological Diseases and Mental Health
Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP)
Institute
Department

Funding Source
Organization Health Labour Sciences Research Grant
Research on Psychiatric and Neurological Diseases and Mental Health
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Japan foundation for neuroscience and mental health
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00736918
Org. issuing International ID_1 Clinical Trials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2006 Year 07 Month 04 Day

Related information
URL releasing protocol http://www.biomedcentral.com/1471-2458/9/364
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
2006 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2011 Year 06 Month 01 Day
Date of closure to data entry
2012 Year 05 Month 01 Day
Date trial data considered complete
2013 Year 05 Month 01 Day
Date analysis concluded
2013 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2006 Year 07 Month 04 Day
Last modified on
2013 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000539

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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