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

Asan Medical Center80 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Depression Suicidal Ideation

Interventions

bupropion or lamotrigineDRUG

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.

Eligibility

Sex: ALLMin age: 11 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Evaluation of Suicidal ideation and behavior

Using Columbia-Suicide Severity Rating Scale(C-SSRS)

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 8 weeks

Genome wide association analysis

KNIH Biobank Array

Time frame: 8 weeks

Central Contacts

lee myungeun, BA

CONTACT

+82-2-3010-7190 lme23@amc.seoul.kr

Sojung Park, BA

CONTACT

+82-2-3010-7190 sojung@amc.seoul.kr

Data from ClinicalTrials.gov

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