Essential Fatty Acids in Management of MDD - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS) scores
研究概览
简要总结
This is a research study to determine whether omega-3 fatty acid supplementation, when taken with the antidepressant medication escitalopram (Lexapro), helps to improve depressive symptoms in individuals who have major depressive disorder (MDD).
Omega-3 fatty acids are found in foods including walnuts, some fruits and vegetables, and coldwater fish such as herring, mackerel, sturgeon, and anchovies.
详细描述
Primary aims
Aim 1: To determine whether measures of essential fatty acid (EFA) membrane composition predict symptom improvement during selective serotonin reuptake inhibitor (SSRI) treatment of major depressive disorder.
Aim 2: To determine whether augmentation with the EFA eicosapentaenoic acid (EPA) is likely to benefit patients who have had an inadequate improvement following four weeks of SSRI monotherapy.
Aim 3: To determine the degree to which improvement following omega-3 supplementation in SSRI partial responders reflects changes in the erythrocyte concentrations of EPA and DHA and in the ratio of EPA to arachidonic acid (AA) erythrocyte concentrations.
Secondary Aim:
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV criteria for nonpsychotic MDD
- •Not currently on antidepressants OR not responding to a stable dose of antidepressants
排除标准
- •DSM-IV for substance abuse in past month or dependence past year.
- •Allergy to fish
- •Bleeding disorder or taking warfarin
- •Omega-3 supplements for more than three consecutive days in the preceding month
- •Taking medications (i.e. glucocorticoids) known to produce affective symptoms
- •History of non-response to escitalopram
- •DSM-IV for an eating disorder in the preceding year.
研究组 & 干预措施
1
干预措施: Placebo (Drug)
2
Low Dose
干预措施: Eicosapentaenoic acid (EPA) 0.7 grams/day or 1.5 grams/day (Drug)
3
High Dose
干预措施: Eicosapentaenoic acid (EPA) 0.7 grams/day or 1.5 grams/day (Drug)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS) scores
时间窗: 4 - 10 weeks
次要结局
未报告次要终点