A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)
| Tracking Information | |||||
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| First Received Date ICMJE | August 15, 2008 | ||||
| Last Updated Date | July 24, 2011 | ||||
| Start Date ICMJE | June 2006 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Recurrent incidence rates of suicide attempts [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00736918 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J) | ||||
| Official Title ICMJE | A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J) | ||||
| Brief Summary | This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts |
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| Detailed Description | It is well known that many subjects who survived a suicide attempt will make further suicide attempts, even after the medical treatment at critical emergency unit. To examine the effectiveness of continuous follow-up care by case manager after the suicide attempt, a randomized, controlled, multicenter trial by J-MISP (Japanese Multimodal Intervention Trials).This research project is one of the strategic research projects funded by The Japanese Ministry of Health, Labor and Welfare. In this study, J-MISP will implement the intervention for suicide attempters, a considerably high-risk group of further suicide attempts, who are transported by emergency services. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Post-Suicide Attempt | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 842 | ||||
| Estimated Completion Date | December 2011 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00736918 | ||||
| Other Study ID Numbers ICMJE | J-MISP-01, UMIN Trial ID: C000000444 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Japan Foundation for Neuroscience and Mental Health,, Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP), Administration office | ||||
| Study Sponsor ICMJE | Japan Foundation for Neuroscience and Mental Health | ||||
| Collaborators ICMJE | National Center of Neurology and Psychiatry, Japan | ||||
| Investigators ICMJE |
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| Information Provided By | Japan Foundation for Neuroscience and Mental Health | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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