UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006777
Receipt No. R000008018
Scientific Title Case management for prevention of recurrent suicide attempt
Date of disclosure of the study information 2011/11/28
Last modified on 2011/11/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Case management for prevention of recurrent suicide attempt
Acronym Study for prevention of suicide attempt
Scientific Title Case management for prevention of recurrent suicide attempt
Scientific Title:Acronym Study for prevention of suicide attempt
Region
Japan

Condition
Condition depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary aim of is to examine the effectiveness of an extensive intervention for suicide attempters in prevention of recurrent suicidal behavior, as compared with standard intervention.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes After crisis intervention including psychiatric evaluation,
psychosocial assessment, and psychological education, subjects will be randomly assigned to either
a group receiving continuous case management or a control group receiving standard care.
Key secondary outcomes Suicidal ideation, depressive symptoms, and general health condition will be evaluated as secondary measures.

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 NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Investigation group
After the participants will attend the semi-structured Psychoeducation Program I, which will involve a discussion of psychological changes leading to suicide, risk factors for
suicide and the relationship to psychiatric disorders, they take the standard treatment, Pamphlet on suicide
prevention and case management.
Interventions/Control_2 Control group
After the participants will attend the semi-structured Psychoeducation Program I, which will involve a discussion of psychological changes leading to suicide, risk factors for
suicide and the relationship to psychiatric disorders, they take the standard treatment, Pamphlet on 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) Subject is over 20 years old.
2) Subject has been diagnosed with a psychiatric disorder
classified into DSM-IV axis I.
3) Subject has had suicidal intentions confirmed at least
twice using the Suicide Intent Scale .
4) Subject is able to understand the description of the
study and provide informed consent.
5) During hospitalization, subject is able to attend an
interview and the Psychoeducation Program I , which will be required before enrollment in
the study.
6) Subject is able to visit the participating hospital regularly for evaluations and case management and be contacted directly from the hospital on a regular basis
Key exclusion criteria Individual has a primary diagnosis that is not classified
into DSM-IV axis I.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jotaro Akiyoshi
Organization Oita University Faculty of Medicine
Division name Departemnt of Neuropsychiatry
Zip code
Address Hasama-Machi idaigaoka, Yufu-Shi, Oita
TEL 097-586-5823
Email

Public contact
Name of contact person
1st name
Middle name
Last name Jusen Tsuru
Organization Oita University Faculty of Medicine
Division name Departemnt of Neuropsychiatry
Zip code
Address Hasama-Machi idaigaoka, Yufu-Shi, Oita
TEL 097-586-5823
Homepage URL http://www.med.oita-u.ac.jp/psy/index.html
Email tsuru@oita-u.ac.jp

Sponsor
Institute Oita University Faculty of Medicine
Institute
Department

Funding Source
Organization Oita University Faculty of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 28 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 Open public recruiting
Date of protocol fixation
2010 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 27 Day
Last modified on
2011 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008018

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.