NCT00816322已完成不适用
The Effect of Fish Oil in Major Depressive Disorder: a Double-blind Placebo-controlled Monotherapy Trail and a RCT for Recurrence Prevention
National Science Council, Taiwan1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2005年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- HAMD
研究概览
简要总结
The whole study was divided into two major parts: (A) the 12-week, double-blind, randomized controlled, parallel omega-3 fatty acid monotherapy study in 60 patients with mild to moderate major depressive disorder. (B) The double-blind, randomized controlled, parallel omega-3 fatty acid add-on prevention study in 60 patients with major depressive disorder in recovery status.
The goals of this study were to examine the therapeutic and recurrence prevention effects of omega-3 fatty acids on major depressive disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV criteria for major depressive disorder.
- •Age being age 18-
- •Capacity and willingness to give written informed consent.
排除标准
- •Any major medical illnesses.
- •A recent or past history of any Axis-I diagnoses besides major depressive disorder, including psychotic disorders; cognitively impaired mental disorders; impulse control disorders; substance use disorder or substance abuse (last 6 months prior to the studies); primary anxiety disorders, including post-traumatic stress disorder and panic disorder; and bipolar disorders; or Axis-II diagnoses, i.e. borderline and antisocial personality disorder.
研究组 & 干预措施
omega-3 fatty acids
Active Comparator
EPA 2.1 g/d+DHA 1.1 g/d
干预措施: Omega-3 fatty acids (Dietary Supplement)
Placebo
Placebo Comparator
high oleic oil
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
HAMD
时间窗: W0 W2 W4 W8 W12
次要结局
- Adverse effects(W0 W2 W4 W8 W12)
- Recurrence rate(M0 M1 M2 M3 M4 M6)
- BDI(W0 W2 W4 W8 W12)
研究者
Kuan-Pin
Researcher
National Science Council, Taiwan
研究点 (1)
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