NCT00480207已完成2 期
Randomized Double-blind Controlled Clinical Trial to Assess the Impact of Folic Acid and Omega-3 Fatty Acids Supplementation on the Severity of Depressive Symptoms in Older Adults With Identified Depression
Prof. RH Belmaker1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2007年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- the severity of depressive symptoms
研究概览
简要总结
Our specific aim is to determine the impact of folic acid and omega-3 supplementation on the severity of depressive symptoms among depressed adults aged 65 and above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65+ (year of birth -1942 or below)
- •Depression (as defined by the DSM-IV diagnostic criteria for depression: major or minor depression or dysthymia)
排除标准
- •Co-existing psychiatric disorder (except anxiety disorders)
- •Moderate and severe cognitive impairment
- •Current treatment with anticoagulants, antithrombotics and fibrinolytics
- •Current severe angina with exertion
- •Chronic renal insufficiency
- •Liver cirrhosis
- •Alcohol or drug abuse
结局指标
主要结局
the severity of depressive symptoms
时间窗: baseline, 4th , 8th and 12th week
次要结局
- nutritional status(baseline and end of study)
- possible side effects(baseline, 4th, 8th, and 12th week)
- cognitive status(baseline, 4th, 8th, and 12th week)
研究者
Prof. RH Belmaker
Prof. RH Belmaker
Beersheva Mental Health Center
研究点 (1)
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