跳至主要内容
临床试验/NCT00711971
NCT00711971已完成2 期

Does EPA or DHA Prevent Depressive Symptoms in Pregnancy and Postpartum?

University of Michigan1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
126
试验地点
1
主要终点
Beck Depression Inventory

研究概览

简要总结

This study is designed to test whether an alternative medicine treatment, fish oil, will prevent depressive symptoms in pregnant and postpartum women who have been found to be at risk for depression. Epidemiologists have observed that people who live in countries where people on average eat a diet high in fish have a lower risk of depression than people who live in populations that eat less fish. Postpartum depression is also less common in these countries. The omega-3 fatty acids found in fish oil are thought to be responsible for this beneficial effect of eating fish. The two major omega-3 fatty acids found in fish are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). DHA is an essential building block of the brain and nerve tissue. EPA may act to optimize the electrical signals between nerve cells and brain cells and may help the immune system to function well.

Some researchers have treated people who are already suffering from depression with fish oil. Some of these studies have shown a benefit for the fish oil treatment and others have not. These studies have tested EPA and DHA alone and in various combinations. Currently, it is not known whether EPA or DHA is more effective in preventing and treating depression. Some of the researchers involved in this study have learned how to identify mothers who are most at risk for developing depression during and after pregnancy. This study is designed to learn whether EPA-rich and DHA-rich fish oil supplements will prevent depressive symptoms in women who are at risk to develop depression.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who are more than 12 weeks pregnant but less than 20 weeks pregnant
  • Women who are found to be at risk for depression
  • Women who have been treated for depression in the past
  • Women with depression after a previous pregnancy
  • Women planning to deliver at University of Michigan Hospital

排除标准

  • Women who have major depression or other psychiatric disorders (current substance abuse, schizophrenia, bipolar disorder) at the time of screening
  • Women who are currently taking anti-depressant or other psychiatric medications
  • Women who routinely eat more than 2 fish meals per week
  • Women on anticoagulants (blood thinners)
  • Women currently taking omega-3 fatty acid dietary supplements (fish oil, flaxseed oil or cod liver oil)
  • Women with bleeding disorders such as von Willebrand's disease
  • Women under the age of 18
  • Women with a multiple gestation (twins, for example)
  • Women planning to deliver at another hospital
  • Women planning to move away before 6 weeks after delivery

研究组 & 干预措施

EPA-rich fish oil supplement

Active Comparator

EPA-rich fish oil supplement

干预措施: EPA-rich fish oil supplement (Drug)

DHA-rich fish oil supplement

Active Comparator

DHA-rich fish oil supplement

干预措施: DHA-rich fish oil supplement (Drug)

Soy Oil placebo

Placebo Comparator

Soy oil

干预措施: placebo (Drug)

结局指标

主要结局

Beck Depression Inventory

时间窗: 6 - 8 weeks postpartum

The Beck Depression inventory scores depression based on 21 items, with a score of 0 - 3 on each item where 0 is no depression and a score of 31 or more is clinically depressed. The 21 items were summed to obtain the total score (The maximum possible score is 63.)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ellen Mozurkewich

Adjunct Assistant Professor

University of Michigan

研究点 (1)

Loading locations...

相似试验