Does Fish Oil Prevent Depression in Pregnancy and Postpartum?

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Drug: EPA-rich fish oil supplement
* Drug: DHA-rich fish oil supplement
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EPA-rich fish oil supplement<br>EPA-rich fish oil supplement | Drug: EPA-rich fish oil supplement<br>* 1060 mg EPA plus 274 mg DHA<br>* Other names: ProEPA Xtra;|
| Active Comparator: DHA-rich fish oil supplement<br>DHA-rich fish oil supplement | Drug: DHA-rich fish oil supplement<br>* 900 mg DHA plus 180 mg EPA<br>* Other names: ProDHA;|
| Placebo Comparator: Soy Oil placebo<br>Soy oil | Drug: placebo<br>* control arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory | 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.) | 6 - 8 weeks postpartum |