DepressionNCT01314521
Suicidal Ideation and Behavior in Korean Adolescents With Depression
An observational study of Depression, run by Hallym University Medical Center at 1 site in South Korea.
Trial 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. 1. Being bullied in peer relationships, excessive use of internet, excessive extra-curricular tutoring, sexual abuse in childhood, physical… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Depression
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: outpatients of university hospitals. 50 from Hallym University Sacred Heart Hospital, 50 from Bundang CHA Hospital, 50 from Myongji Hospital.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang-si, Kyeonggi Do, 431-070
Hyun Ju Hong, MD, PhD, +82-31-380-3751, honghj88@gmail.com
Mina Song, MD, +82-10-4760-2990, blue-oboe@hanmail.net
About this study
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.
Read the 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.
- Conditions
- Depression
- Keywords
- Suicide, Depression, Adolescents
- Medical subject headings
- Depression, Suicide
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline only (at any one point during the depressive episode)
Secondary outcomes (3)
Beck suicidal ideation scale
self report form of 19 items with 3 point scale. for subjects and their parents.
Measured: baseline only
Revised Children's Manifest Anxiety Scale; RCMAS
Measured: baseline only
Beck Depression Inventory
Measured: baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startJan 2011
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bundang CHA Hospital, Myongji Hospital
- Responsible party
- Sponsor
- Investigators
- Hyun Ju Hong, MD, PhD, Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314521
- Sponsor's protocol ID
- SKAD
- Status last verified
- Mar 2011
- First submitted
- 9 Mar 2011
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicidal Ideation and Behavior in Korean Adolescents With Depression
- ClinicalTrials.gov ID
- NCT01314521
- Acronym / sponsor ID
- SKAD
- Conditions
- Depression
- Keywords
- Suicide, Depression, Adolescents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Collaborators
- Bundang CHA Hospital, Myongji Hospital
- Study start
- Jan 2011
- Study completion
- Mar 2012 (estimated)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- outpatients of university hospitals. 50 from Hallym University Sacred Heart Hospital, 50 from Bundang CHA Hospital, 50 from Myongji Hospital.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Columbia Suicide Severity Rating Scale; C-SSRS
Time frame: baseline only (at any one point during the depressive episode)
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).
3 secondary outcomes
Beck suicidal ideation scale
Time frame: baseline only
Revised Children's Manifest Anxiety Scale; RCMAS
Time frame: baseline only
Beck Depression Inventory
Time frame: baseline only
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Ju Hong, MD, PhD principal investigator
Hallym University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Hallym University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mina Song, MD (+82-10-4760-2990, blue-oboe@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columbia Suicide Severity Rating Scale; C-SSRS (time frame: baseline only (at any one point during the depressive episode)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2011.