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RCT of Post-Suicide Attempt Case Management (ACTION-J)

This study has been completed.
Sponsor:
Collaborator:
National Center of Neurology and Psychiatry, Japan
Information provided by (Responsible Party):
Japan Foundation for Neuroscience and Mental Health
ClinicalTrials.gov Identifier:
NCT00736918
First received: August 15, 2008
Last updated: January 14, 2014
Last verified: January 2014

August 15, 2008
January 14, 2014
June 2006
June 2011   (final data collection date for primary outcome measure)
First recurrent suicide behavior (suicide attempted and completed suicide) [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
Recurrent incidence rates of suicide attempts [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00736918 on ClinicalTrials.gov Archive Site
  • Any cause of death [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
  • Repeated recurrent incidence of suicide attempts [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
  • Utilization or personal or social resources [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: No ]
  • Number of self-injury [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
  • Health care utilization [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: No ]
  • Physical function [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
  • Beck hopeless scale [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
  • Any cause of death [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
  • Number and rates of repeated recurrent incidence of suicide attempts [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
  • Utilization or personal or social resources [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: No ]
  • Number of self-injury [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
  • Health care utilization [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: No ]
  • Physical function [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
  • Beck hopeless scale [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Minimum 1.5 year ] [ Designated as safety issue: Yes ]
  • Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 1 month after the randomization ] [ Designated as safety issue: Yes ]
  • Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 3 months after the randomization ] [ Designated as safety issue: Yes ]
  • Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 6 months after the randomization ] [ Designated as safety issue: Yes ]
  • Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 12 months after the randomization ] [ Designated as safety issue: Yes ]
  • Incidence proportion of the first episode of recurrent suicidal behaviour (attempted suicide or completed suicide) [ Time Frame: at 18 months after the randomization ] [ Designated as safety issue: Yes ]
Not Provided
 
RCT of Post-Suicide Attempt Case Management (ACTION-J)
A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)

This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Suicide Attempt
  • Behavioral: Case management
    Case management, Usual clinical practice and Providing paper based information for suicide prevention
  • Other: Enhanced usual care
    Usual clinical practice and Providing paper based information for suicide prevention
  • Experimental: Case management
    Case management
    Intervention: Behavioral: Case management
  • Active Comparator: Enhanced usual care
    Enhanced usual care
    Intervention: Other: Enhanced usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
914
October 2013
June 2011   (final data collection date for primary outcome measure)

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 assessment at continuous follow-up care by case manager at the hospital

Exclusion Criteria:

  1. Not suffering from Axis I disorder as a primary diagnosis
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00736918
J-MISP-01, C000000444
Yes
Japan Foundation for Neuroscience and Mental Health
Japan Foundation for Neuroscience and Mental Health
National Center of Neurology and Psychiatry, Japan
Principal Investigator: Yoshio Hirayasu, MD,PhD Yokohama City University
Japan Foundation for Neuroscience and Mental Health
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP