Efficacy and Safety of Resveratrol in the Treatment of Depression: Double-blind Randomized Placebo-controlled Parallel-group Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Total HDRS-17 Score From Baseline to Week 4
研究概览
简要总结
Patients with depression (target number - 60) receive resveratrol 500 mg or placebo (1:1) each morning daily for 1 month with primary outcome measures of the score change on depression rating scale HDRS-17 and change in SIRT1 activity in the blood measured 4 times over the study period (before, in the middle, after the intervention, and in 2 week follow up).
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Resveratrol Pill
干预措施: Resveratrol Pill (Drug)
Placebo
干预措施: Placebos (Drug)
结局指标
主要结局
Change in Total HDRS-17 Score From Baseline to Week 4
时间窗: 4 weeks
Hamilton Depression Rating Scale 17 items, total score range 0-53 (53 - worse)
Change in SIRT1 Activity From Baseline to Week 4
时间窗: 4 weeks
SIRT1 is enzyme sirtuin-1 which activity is measured in the blood
次要结局
- Change in Total BDI-II Score From Baseline to Week 4(4 weeks)
研究者
Lyubomir I Aftanas, MD, PhD, DrSci., Prof.
Director of the Institute of Physiology and Basic Medicine, Principal Investigator
Russian Academy of Medical Sciences