Suicidal Ideation and Behavior in Korean Adolescents With... | NCT01314521

Studies
Suicidal Ideation and Behavior in Korean Adolescents With Depression

NCT01314521

Sponsor

Hallym University Medical Center

Status

Unknown status

Last Update Posted

Oct 5, 2011Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Depression

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Not provided

Completion Date

Mar 2012Estimated

First Submitted Date

Mar 9, 2011

First Submission Date that Met QC Criteria

Mar 11, 2011

First Posted Date

Mar 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2011

Last Update Posted Date

Oct 5, 2011Estimated

Name	Class
Bundang CHA Hospital	OTHER
Myongji Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to examine clinical characteristics of Korean adolescents with depression who have suicidal ideation and behavior. We formulate those hypotheses.

Being bullied in peer relationships, excessive use of internet, excessive extra-curricular tutoring, sexual abuse in childhood, physical abuse and emotional neglect are risk factors of suicide in adolescents.
Depression of parents and negative child-rearing attitude are risk factors of suicidal ideation and behavior in adolescents.
Emotional quotient (EQ) and resilience of adolescent are protective factors of suicide.

Detailed Description

Korea has reported the highest suicide rate among OECD members and according to the data from the Korea national statistical office, suicide is the second major cause of death in adolescents and is increasing. Depression, one of the well-known risk factors of suicide in adolescents, can cause maladjustments to school and family life, problems of interpersonal relationship and drug abuse so that work to trigger the suicidal ideation and behavior. In his study, we planned to examine the relationship between suicidal ideation and behavior and several risk factors by using the standardized diagnostic clinical interview, especially an objective suicide evaluating method which has recently developed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Columbia Suicide Severity Rating Scale; C-SSRS	Semi-structured clinical interview based on the systematic guideline which help draw inferences about suicidal ideation from clinical situation and risk factors related to the suicide. It is composed with three categories that are suicidal attempt (ideation), non-suicidal attempt (ideation), and potential of suicidal attempt (ideation).	baseline only (at any one point during the depressive episode)

Secondary Outcomes

Measure	Description	Time Frame
Beck suicidal ideation scale	self report form of 19 items with 3 point scale. for subjects and their parents.	baseline only
Revised Children's Manifest Anxiety Scale; RCMAS		baseline only

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

a subject who has depression (Major depressive disorder, dysthymic disorder, depressive disorder NOS) diagnosed by Kiddie-Schedule for affective disorder and schizophrenia (K-SADS-PL-K)
subjects and their family (a parent or a grandparent) or their legal representative consent to participate in this study voluntarily
subjects and their family (a parent or a grandparent) or their legal representative are able to understand the meaning of participation in this study and able to reject or ask to leave from this study

Exclusion Criteria:

a patient who has diagnosed with bipolar disorder, psychotic disorder, pervasive developmental disorder, organic brain disease, or epilepsy
a patient with mental retardation who is IQ under 70
a patient who has a severe medical illness (chronic physical disease, cardiovascular, hepatobiliary, nephrology, or respiratory disease and so on)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

outpatients of university hospitals. 50 from Hallym University Sacred Heart Hospital, 50 from Bundang CHA Hospital, 50 from Myongji Hospital.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mina Song, MD	Contact	+82-10-4760-2990		blue-oboe@hanmail.net
Hyun Ju Hong, MD, PhD	Contact	+82-31-380-3751		honghj88@gmail.com

Overall Officials

Name	Affiliation	Role
Hyun Ju Hong, MD, PhD	Hallym University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hallym University Sacred Heart Hospital	Recruiting	Anyang-si	Kyeonggi Do	431-070	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D013405	Suicide

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D016728	Self-Injurious Behavior

Browse Leaves

Not provided

Browse Branches

Not provided