The Efficacy and Safety of Adjunctive Curcumin for Treatment of Depression: A Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale
研究概览
简要总结
Antidepressants generally do not lead to an immediate relief of symptoms. Most people will not see a significant improvement for at least 4 weeks. Studies have generally shown that the full benefits of antidepressant therapy may take as long as 8 to 12 weeks. However, this timeline is variable among individuals.Curcumin is one of the main curcuminoids isolated from this perennial herb. It possesses a variety of pharmacological activities, including anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects. Curcumin has been found to possess antidepressant action in various animal models of depression. Chronic administration of curcumin has been reported to exert antidepressant-like action in olfactory bulbectomy model of depression in rats. Although the mechanism of the antidepressant effect of curcumin is not fully understood, it is hypothesized that it acts through inhibiting the monoamine oxidase enzyme and modulating the release of serotonin and dopamine.In randomized, double-blind, placebo-controlled study 40 patients will be randomized to receive either 500 mg/day of curcumin or placebo together with antidepressants for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- 未提供
排除标准
- •Evidence of organic brain damage
- •Mental retardation
- •Alcohol or drug abuse
- •An unstable medical condition
- •Any significant medical or neurological illness
- •Patients with a known hypersensitivity to curcumin or other components of the product
- •Pregnant women or women who intend to become pregnant
- •Receiving any antidepressant and mood-stabilizers
研究组 & 干预措施
curcumin
干预措施: curcumin (Drug)
placebo
干预措施: curcumin (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale
时间窗: Change in the scores from baseline at six weeks
Montgomery-Asberg Depression Rating Scale
时间窗: Change in the scores from baseline at six weeks
次要结局
- Clinical Global Impression(Change in the scores from baseline at six weeks)
研究者
Vladimir Lerner
A/Professor, Head of department
Beersheva Mental Health Center
