Genetic Markers and Predictors of Antidepressant-induced Suicidality in Youth Depression
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluation of Suicidal ideation and behavior
研究概览
简要总结
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Increased suicidality
Increase in suicidal ideation after taking the standardized pharmacotherapy (bupropion or lamotrigine) during 8 weeks.
干预措施: bupropion or lamotrigine (Drug)
Non-increased suicidality
Non-increase of suicidal ideation after taking the standardized pharmacotherapy (bupropion or lamotrigine) during 8 weeks.
干预措施: bupropion or lamotrigine (Drug)
结局指标
主要结局
Evaluation of Suicidal ideation and behavior
时间窗: 8 weeks
Using Columbia-Suicide Severity Rating Scale(C-SSRS)
次要结局
- Evaluation of treatment effect of antidepressants(CDRS)(8 weeks)
- Evaluation of treatment effect of antidepressants (YMRS)(8 weeks)
- Evaluation of treatment effect of antidepressants(P-GBI)(8 weeks)
- Evaluation of treatment effect of antidepressants(CGI-S)(8 weeks)
- Genome wide association analysis(8 weeks)
研究者
Hyo-Won Kim
Assistant professor, department of psychiatry, Asan Medical Center
Asan Medical Center