Eicosapentaenoic Acid and Specialized Pro-Resolving Mediator for Depressive Symptoms in Long COVID: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HAMD)
研究概览
简要总结
Researchers conducted a 12-week, double-blind, randomized, placebo-controlled trial to assess the effectiveness of EPA or SPM treatments versus a placebo in managing Long COVID symptoms in adult patients. Researchers planned to enroll 240 eligible participants from various general and psychiatric hospitals in Taiwan. The focus was on evaluating the therapeutic impact and potential side effects of administering 3 g/day of EPA or 1.67 mg/day of SPMs on symptoms of depression in these patients. This consolidated approach aims to provide comprehensive insights into the efficacy of EPA and SPM treatments in Long COVID cases, addressing crucial mental health aspects.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed SARS-CoV-2 infection by PCR, documented positive test, or clinician diagnosis
- •Meeting CDC criteria for Post-COVID Conditions (Long COVID) as the presence of new, returning, or ongoing symptoms ≥4 weeks after confirmed SARS-CoV-2 infection
- •Hamilton Depression Rating Scale (HAMD-21) score ≥18 at baseline
- •Stable antidepressant treatment for ≥4 weeks or no current antidepressant use; and
- •Ability to provide written informed consent
排除标准
- •Current or past six-month diagnosis of psychotic disorder, bipolar disorder, substance use disorder, or other major psychiatric conditions based on ICD-10 or DSM-5 criteria
- •Significant neurological or medical comorbidities (eg, epilepsy, traumatic brain injury, autoimmune disease, cancer), acute infections, or clinically significant laboratory abnormalities
- •Regular use of SPM or EPA supplementation >0·5 g/day
- •Known allergy or intolerance to omega-3 fatty acids or SPMs; and
- •Requirement for inpatient psychiatric care due to acute suicide risk
研究组 & 干预措施
Eicosapentaenoic acid (EPA)
Eicosapentaenoic acid (EPA) at a total daily dose of 3 g, administered as six capsules
干预措施: Eicosapentaenoic acid (omega-3 fatty acid) (Dietary Supplement)
Specialized pro-resolving mediators (SPMs)
SPM at a total daily dose of 1.67 g, administered as six capsules
干预措施: Specialized Pro-Resolving Lipid Mediator (Dietary Supplement)
Placebo
soybean oil
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Hamilton Depression Rating Scale (HAMD)
时间窗: (week 0) and at weeks 1, 2, 4, 8, and 12
Adult depressive symptoms were assessed using the 21-item HAMD at baseline (week 0) and at weeks 1, 2, 4, 8, and 12.
次要结局
- Erythrocyte Omega-3 Polyunsaturated Fatty Acids(Week 0 and Week 12)
研究者
Kuan-Pin
Professor
National Science and Technology Council, Taiwan