UMIN-CTR Clinical Trial

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

depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Oita University Faculty of Medicine

Institute

Department

Personal name

Organization

Oita University Faculty of Medicine

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

11

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

11

Month

27

Day

Last modified on

2011

Year

11

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008018