Omega-3 Fatty Acids, Inflammation, Gut Microbiota in Youth With Depression (OMIMYDep)- A Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- clinical symptoms
研究概览
简要总结
This is a 12 week double blind RCT aimed to investigate the role of omega-3 fatty acids in patients with major depressive disorder
详细描述
This is a 12 week double blind RCT aimed to investigate the role of omega-3 fatty acids in patients with major depressive disorder. Outcome measures including clinical symptoms, inflammation biomarkers and gut microbiota profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Youth with a DSM-5 diagnosis of MDE
排除标准
- •Has a recent change in antidepressants or psychotherapy treatment within 4 weeks.
- •Allergic to omega-3 fatty acids
研究组 & 干预措施
omega-3
EPA
干预措施: Omega-3 fatty acids (Combination Product)
placebo
soy bean oil
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
clinical symptoms
时间窗: week 0,1,2,4,8,12
Hamilton Depression Rating Scale (HAMD)-21 item is a clinician-rated scale designed to assess the severity of depressive symptoms over the past week. It is commonly used in clinical trials and psychiatric practice Total Score Interpretation (Commonly Used) Total Score and Severity Level * 0-7: No depression / Normal * 8-13: Mild depression * 14-18: Moderate depression * 19-22: Severe depression -≥23: Very severe depression
次要结局
- gut microbiota(week 0,12)
- inflammatory cytokines (IL-6, hsCRP)(week 0,12)
研究者
Pei-Chen Chang
Consultant Psychiatrist
China Medical University Hospital