DepressionNCT02428439
Identification of Genetic Markers and Predictors of Antidepressant-induced Suicidality in Youth Depression
An observational study of Depression and Suicidal Ideation, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The objective of this study is to identification of genetic markers and predictors of antidepressant-induced suicidality in youth depression. Participants who take the standardized pharmacotherapy (bupropion or lamotrigine) for depression will be observed for 8 weeks. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Depression, Suicidal Ideation
- What is being tested?
- bupropion or lamotrigine
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to 30 Jun 2020
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents between 11 years and 18 years in depressed psychiatric outpatients. increased suicidal ideation: 14 people, non-increased suicidal ideation: 54 people, patient drop-out rate: 20%, total 80 people.
Who may be able to join
- Aged between 11 and 18 years
- Met the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL) diagnostic criteria for depressive episode or dysthymia
- Intelligence quotient higher than 70 on the Korean Educational Developmental Institute's Wechsler Intelligence Scale for Children
Who cannot join
- presence of intellectual disability
- presence of hereditary disorder
- past and/or current history of acquired brain injury, like cerebral palsy
- presence of seizure, other neurological disorder or sensory impairments
- past and/or current history of pervasive developmental disorder
- past and/or current history of schizophrenia, bipolar disorder or psychosis
- presence of severe learning disorder
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Hyo-Won Kim, 82-2-3010-3414, shingubi@amc.seoul.kr
About this study
Official title: Genetic Markers and Predictors of Antidepressant-induced Suicidality in Youth Depression
The objective of this study is to identification of genetic markers and predictors of antidepressant-induced suicidality in youth depression. Participants who take the standardized pharmacotherapy (bupropion or lamotrigine) for depression will be observed for 8 weeks. They will do several scales and genetic tests at visit 1 (week 0), visit 3 (week 4) and visit 4 (week 8)
- Conditions
- Depression, Suicidal Ideation
- Being tested
- bupropion or lamotrigine
- Keywords
- genetic markers, predictors, Antidepressive Agents, Suicidal Ideation, Adolescent
- Medical subject headings
- Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupropion or lamotrigineDrug
Also called Wellbutrin, Lamictal
Participants who take the standardized pharmacotherapy (bupropion or lamotrigine) for depression will be observed for 8 weeks. Drugs using in this study are the standard treatment for depression, and are NOT administered as part of this study.
| Study group | Role | What they receive |
|---|---|---|
| Increased suicidality | Increase in suicidal ideation after taking the standardized pharmacotherapy (bupropion or lamotrigine) during 8 weeks. Receives: Drug: bupropion or lamotrigine | |
| Non-increased suicidality | Non-increase of suicidal ideation after taking the standardized pharmacotherapy (bupropion or lamotrigine) during 8 weeks. Receives: Drug: bupropion or lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Suicidal ideation and behavior
Using Columbia-Suicide Severity Rating Scale(C-SSRS)
Measured: 8 weeks
Secondary outcomes (5)
Evaluation of treatment effect of antidepressants(CDRS)
A composite measure consisting of Children's Depression Rating scale(CDRS). Modeled after the Hamilton Rating Scale for Depression, the CDRS is a clinical interview tool designed for assessing 6-12 year-olds, and it has also been used successfully for adolescents.
Measured: 8 weeks
Evaluation of treatment effect of antidepressants (YMRS)
A composite measure consisting of Young Mania Rating Scale(YMRS). The YMRS is an 11-item scale used to assess the severity of mania in children and adolescents ages 5-17.The YMRS has been used in clinical practice since 1978. Ratings are based on child/adolescent self-reporting and clinician observation. This instrument does not assess depressed mood.
Measured: 8 weeks
Evaluation of treatment effect of antidepressants(P-GBI)
The P-GBI is adapted from the General Behavior Inventory, and allows parents to rate depressive, hypomanic, manic, and alternating mood symptoms in their children and adolescents ages 5-17.
Measured: 8 weeks
Evaluation of treatment effect of antidepressants(CGI-S)
The Clinical Global Impression rating scales(CGI-S) are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders.
Measured: 8 weeks
Genome wide association analysis
KNIH Biobank Array
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Jun 2020 (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.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Won Kim, Asan Medical Center
- Investigators
- Hyowon Kim, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428439
- Sponsor's protocol ID
- S2015-0305-0003
- Status last verified
- Jul 2019
- First submitted
- 20 Apr 2015
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Markers and Predictors of Antidepressant-induced Suicidality in Youth Depression
- ClinicalTrials.gov ID
- NCT02428439
- Acronym / sponsor ID
- S2015-0305-0003
- Conditions
- Depression, Suicidal Ideation
- Keywords
- genetic markers, predictors, Antidepressive Agents, Suicidal Ideation, Adolescent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 28 Apr 2015 (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 objective of this study is to identification of genetic markers and predictors of antidepressant-induced suicidality in youth depression. Participants who take the standardized pharmacotherapy (bupropion or lamotrigine) for depression will be observed for 8 weeks. They will do several scales and genetic tests at visit 1 (week 0), visit 3 (week 4) and visit 4 (week 8)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Increased suicidality | – | Drug: bupropion or lamotrigineIncrease in suicidal ideation after taking the standardized pharmacotherapy (bupropion or lamotrigine) during 8 weeks. |
| Non-increased suicidality | – | Drug: bupropion or lamotrigineNon-increase of suicidal ideation after taking the standardized pharmacotherapy (bupropion or lamotrigine) during 8 weeks. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents between 11 years and 18 years in depressed psychiatric outpatients. increased suicidal ideation: 14 people, non-increased suicidal ideation: 54 people, patient drop-out rate: 20%, total 80 people.
Key inclusion criteria (3 listed)
- Aged between 11 and 18 years
- Met the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL) diagnostic criteria for depressive episode or dysthymia
- Intelligence quotient higher than 70 on the Korean Educational Developmental Institute's Wechsler Intelligence Scale for Children
Key exclusion criteria (7 listed)
- presence of intellectual disability
- presence of hereditary disorder
- past and/or current history of acquired brain injury, like cerebral palsy
- presence of seizure, other neurological disorder or sensory impairments
- past and/or current history of pervasive developmental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupropion or lamotrigineAlso: Wellbutrin, LamictalParticipants who take the standardized pharmacotherapy (bupropion or lamotrigine) for depression will be observed for 8 weeks. Drugs using in this study are the standard treatment for depression, and are NOT administered as part of this study. | Drug | Increased suicidality, Non-increased suicidality |
Primary outcome
Evaluation of Suicidal ideation and behavior
Time frame: 8 weeks
Using Columbia-Suicide Severity Rating Scale(C-SSRS)
5 secondary outcomes
Evaluation of treatment effect of antidepressants(CDRS)
Time frame: 8 weeks
Evaluation of treatment effect of antidepressants (YMRS)
Time frame: 8 weeks
Evaluation of treatment effect of antidepressants(P-GBI)
Time frame: 8 weeks
Evaluation of treatment effect of antidepressants(CGI-S)
Time frame: 8 weeks
Genome wide association analysis
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Hyowon Kim, Professor principal investigator
Asan 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 and Suicidal Ideation, run by Asan 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 7 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 Jul 2019. 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 lee myungeun, BA (+82-2-3010-7190, lme23@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Suicidal ideation and behavior (time frame: 8 weeks). 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 Jul 2019.