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

Study Overview
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Brief Summary
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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)

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

Conditions
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Depression, Suicidal Ideation

Intervention / Treatment
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* Drug: bupropion or lamotrigine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Increased suicidality<br>Increase in suicidal ideation after taking the standardized pharmacotherapy (bupropion or lamotrigine) during 8 weeks. | Drug: bupropion or lamotrigine<br>* 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.<br>* Other names: Lamictal;|
| Non-increased suicidality<br>Non-increase of suicidal ideation after taking the standardized pharmacotherapy (bupropion or lamotrigine) during 8 weeks. | Drug: bupropion or lamotrigine<br>* 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.<br>* Other names: Lamictal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Suicidal ideation and behavior | Using Columbia-Suicide Severity Rating Scale(C-SSRS) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 8 weeks | 
| Genome wide association analysis | KNIH Biobank Array | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genetic markers, predictors, Antidepressive Agents, Suicidal Ideation, Adolescent