Skip to content

Identification of Genetic Markers and Predictors of Antidepressant-induced Suicidality in Youth Depression

Genetic Markers and Predictors of Antidepressant-induced Suicidality in Youth Depression

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02428439
Enrollment
80
Registered
2015-04-28
Start date
2015-04-30
Completion date
2020-06-30
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Suicidal Ideation

Keywords

genetic markers, predictors, Antidepressive Agents, Suicidal Ideation, Adolescent

Brief 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. They will do several scales and genetic tests at visit 1 (week 0), visit 3 (week 4) and visit 4 (week 8)

Interventions

DRUGbupropion or lamotrigine

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.

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

1. Aged between 11 and 18 years 2. Met the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL) diagnostic criteria for depressive episode or dysthymia 3. Intelligence quotient higher than 70 on the Korean Educational Developmental Institute's Wechsler Intelligence Scale for Children

Exclusion criteria

1. presence of intellectual disability 2. presence of hereditary disorder 3. past and/or current history of acquired brain injury, like cerebral palsy 4. presence of seizure, other neurological disorder or sensory impairments 5. past and/or current history of pervasive developmental disorder 6. past and/or current history of schizophrenia, bipolar disorder or psychosis 7. presence of severe learning disorder

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of Suicidal ideation and behavior8 weeksUsing Columbia-Suicide Severity Rating Scale(C-SSRS)

Secondary

MeasureTime frameDescription
Evaluation of treatment effect of antidepressants(CDRS)8 weeksA 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.
Evaluation of treatment effect of antidepressants (YMRS)8 weeksA 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.
Evaluation of treatment effect of antidepressants(P-GBI)8 weeksThe 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.
Evaluation of treatment effect of antidepressants(CGI-S)8 weeksThe 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.
Genome wide association analysis8 weeksKNIH Biobank Array

Countries

South Korea

Contacts

Primary Contactlee myungeun, BA
lme23@amc.seoul.kr+82-2-3010-7190
Backup ContactSojung Park, BA
sojung@amc.seoul.kr+82-2-3010-7190

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026