UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000444 |
|---|---|
| Receipt number | 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 15:42:54 |
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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
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
sp_ycu@yokohama-cu.ac.jp
Sponsor or person
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
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000539
