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Completed

NCT Number: NCT00711971

Does Fish Oil Prevent Depression in Pregnancy and Postpartum?

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPA-rich fish oil supplement

Drug

1060 mg EPA plus 274 mg DHA

Other names: ProEPA Xtra

DHA-rich fish oil supplement

Drug

900 mg DHA plus 180 mg EPA

Other names: ProDHA

Placebo

Drug

control arm

Primary outcomes

  1. Beck Depression Inventory

    Time frame: 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.)

Other outcomes

  1. Maternal Outcomes

    Time frame: visits at 26 - 28 weeks gestational age, 34-36 weeks gestational age during pregnancy and at the post partum visit 6- 8 weeks after delivery

    While the maternal outcomes assess criteria during pregnancy and relating to delivery they were assessed at visits 26 - 28 weeks gestational age, 34-36 weeks gestational age and at the post partum visit 6- 8 weeks after delivery.

  2. Gestational Age at Delivery (Weeks)

    Time frame: delivery date was assessed by medical record review between 1 day and 8 weeks after delivery

  3. Estimated Blood Loss (ml)

    Time frame: Within 24 hours after delivery

  4. Neonatal Birthweight

    Time frame: immediately after birth

    Mean weight in grams: where <2500 gm is considered small for gestational age and >4500 gm is considered large for gestational age.

  5. NICU (Neonatal Intensive Care Unit) Admissions

    Time frame: 6 weeks post delivery

    Admission to the NICU

  6. One Minute Apgar Score

    Time frame: 1 minute after birth

    Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the one minute Apgar.

  7. Five Minute Apgar Score

    Time frame: 5 minutes after birth

    Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the five minute Apgar.

  8. Cord Arterial pH

    Time frame: Immediately after birth (collected within the first hour after delivery)

    Arterial blood gas analysis of umbilical cord blood

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Jul 9, 2008
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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