Does Fish Oil Prevent Depression in Pregnancy and Postpartum?
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: EPA-rich fish oil supplement Drug: DHA-rich fish oil supplement Drug: placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Does EPA or DHA Prevent Depressive Symptoms in Pregnancy and Postpartum? |
- Beck Depression Inventory [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
| Enrollment: | 126 |
| Study Start Date: | September 2008 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
EPA-rich fish oil supplement
|
Drug: EPA-rich fish oil supplement
1060 mg EPA plus 274 mg DHA
Other Name: ProEPA Xtra
|
|
Active Comparator: 2
DHA-rich fish oil supplement
|
Drug: DHA-rich fish oil supplement
900 mg DHA plus 180 mg EPA
Other Name: ProDHA
|
| Placebo Comparator: 3 |
Drug: placebo
control arm
Other Name: placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Michigan | |
| University of Michigan Hospital | |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: | Ellen Mozurkewich, MD, MS | University of Michigan |
More Information
No publications provided by University of Michigan
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ellen Mozurkewich, Adjunct Assistant Professor, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT00711971 History of Changes |
| Other Study ID Numbers: | R21 AT004166-01A1, R21AT004166-01A1, IRBMED# HUM00004684 |
| Study First Received: | July 7, 2008 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration United States: Federal Government |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013