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Does Fish Oil Prevent Depression in Pregnancy and Postpartum?
This study is not yet open for participant recruitment.
Verified by National Center for Complementary and Alternative Medicine (NCCAM), July 2008
First Received: July 7, 2008   No Changes Posted
Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00711971
  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
Dietary Supplement: EPA-rich fish oil supplement
Dietary Supplement: DHA-rich fish oil supplement
Other: placebo
Phase II
Phase III

MedlinePlus related topics: Depression Dietary Supplements Diets Postpartum Care
Drug Information available for: Fish oil
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
Official Title: Does EPA or DHA Prevent Depressive Symptoms in Pregnancy and Postpartum?

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: August 2008
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
EPA-rich fish oil supplement
Dietary Supplement: EPA-rich fish oil supplement
1060 mg EPA plus 274 mg DHA
2: Active Comparator
DHA-rich fish oil supplement
Dietary Supplement: DHA-rich fish oil supplement
900 mg DHA plus 180 mg EPA
3: Placebo Comparator Other: placebo
control arm

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711971

Contacts
Contact: Julie Chilimigras, MPH jlc@umich.edu

Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Investigators
Principal Investigator: Ellen Mozurkewich, MD, MS University of Michigan
  More Information

No publications provided

Responsible Party: University of Michigan ( Ellen Mozurkewich, MD, MS )
Study ID Numbers: R21 AT004166-01A1, IRBMED# HUM00004684
Study First Received: July 7, 2008
Last Updated: July 7, 2008
ClinicalTrials.gov Identifier: NCT00711971     History of Changes
Health Authority: United States: Institutional Review Board;   United States: Food and Drug Administration;   United States: Federal Government

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:
Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 07, 2009