Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- the change from baseline in CDRS-R at week 8 or upon termination
研究概览
简要总结
The aims of this study are to (1) identify inflammatory/neurotrophic and neurodevelopmental markers that predict antidepressant response and suicidal risk in depressed youth and (2) predict their treatment response and the occurrence of suicidal events at the individual level using machine learning approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of major depressive disorder(MDD) according to criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- •current episode at least 4 weeks in duration at baseline
- •with a score of at least 40 on the Children's Depression Rating Scale-Revised (CDRS-R), and CGI-Severity ≥4 at baseline
排除标准
- •intelligence quotient (IQ) lower than 70
- •psychotic features or first-degree relatives with a history of bipolar I disorder
- •alcohol or substance abuse within the past 6 months
- •history of schizophrenia, bipolar disorder, eating disorder, or autism
- •history of neurological diseases including convulsive disorders or brain damage
- •concurrent medications with psychotropic effects (other than stimulants for ADHD)
- •chronic medical conditions (e.g., asthma, inflammatory bowel disease, diabetes) and/or chronic medication with psychotropic effects (e.g., anticonvulsants) or chronic use of NSAIDS or other drugs with known impact on inflammatory pathways.
研究组 & 干预措施
Escitalopram
Participants with depression were treated with escitalopram(ranging from 5mg to 30mg) for 8 weeks. Escitalopram was initiated at 5mg for 1 week, followed by an increase to 10mg at week 2. After week 2, doses of escitalopram were titrated according to symptoms and adverse effects. Specific, indicated psychotherapy for depression was not allowed during the study.
干预措施: Escitalopram (Drug)
结局指标
主要结局
the change from baseline in CDRS-R at week 8 or upon termination
时间窗: baseline and 8 weeks or upon termination
The Children's Depression Rating Scale-Revised (CDRS-R) is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items. Depression symptoms are rated on a 5-point scale from 1 to 5 for sleep, appetite, and tempo of speech items and a 7-point scale from 1 to 7 for remaining 14 items. The total score ranges form 17 (normal) to 113 (severe depression). Change from baseline CDRS-R at 8 weeks or upon termination was calculated as baseline minus 8 weeks in the adjusted CDRS-R total score (CDRS-R total minus 17, the minimum possible total score).
次要结局
- CGI-I at 8 weeks or upon termination(baseline and 8 weeks or upon termination)
研究者
Jae-Won Kim
Professor
Seoul National University