Omega-3 Fatty Acids for Treatment of Major Depression: Differential Effects of EPA and DHA, and Associated Biochemical and Immune Parameters
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Score on a Depression Severity Rating Scale Over Eight Weeks
研究概览
简要总结
This study examines the difference in the effectiveness of two natural compounds, eicosapentanoic (EPA) and docosahexanoic (DHA)omega-3 fatty acids, in treating major depressive disorder. Both types of omega-3 fatty acids are commonly found in fish oils. It is believed that a deficiency in these omega-3 fatty acids may lead to the development of major depression.
详细描述
The study lasts for eight weeks and involves four visits after the screen and baseline visits (biweekly). Participants will be randomized, or chosen by chance, to enter into one of three groups. People in the first group will take 1 g/day or EPA omega-3 fatty acid, those in the second group will take 1 g/day of DHA omega-3 fatty acid, and those in the third group will take a placebo. This study is double-blind, which means that neither the participant, nor the doctor, nor the research staff will know which group each person is in. At the end of the study the participant will be offered three months of follow-up care at the Depression Clinical and Research Program.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18-80 years old.
- •Must meet criteria for current Major Depressive Disorder.
排除标准
- •Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease
- •History of seizure disorder.
- •Substance use disorders, including alcohol, active within the last six months (past history is OK).
- •History of multiple adverse drug reactions or allergy to the study drugs.
研究组 & 干预措施
EPA
Eicosapentaenoic acid (EPA) Omega-3, 1g/day
干预措施: eicosapentaenoic acid (Dietary Supplement)
DHA
Docosahexaenoic acid (DHA) Omega-3, 1g/day
干预措施: docosahexaenoic acid (Dietary Supplement)
Placebo
Placebo capsule (980mg soybean oil)
干预措施: Placebo (Drug)
结局指标
主要结局
Score on a Depression Severity Rating Scale Over Eight Weeks
时间窗: 8 weeks
Change in score on 17-item Hamilton D depression severity rating scale over 8 weeks of treatment. Scores were obtained every 2 weeks for 8 weeks. The total sum score of the 17 items is used to assess depressive severity. Possible total scores range from 0-52, with a higher score indicating greater depressive severity. Scores of 7 or less are indicative of full remission (i.e. no depression). Scores of 8-15 indicate mild depression; scores of 16-25 indicate moderate depression; scores of 25 or greater indicate severe depression. Mixed model repeated measures analysis (MMRM) was used to examine treatment group effect on changes from baseline to week 8 in Hamilton D scores. Models included subjects as a random effect, and treatment group and study week as fixed effects. An auto-regressive covariance structure was used because it provided the best fit to the data. Site and baseline score were included as covariates in all models.
次要结局
未报告次要终点
研究者
David Mischoulon, MD
Principal Investigator
Massachusetts General Hospital