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CompletedNCT00711971Updated Apr 28, 2017Results posted

Does Fish Oil Prevent Depression in Pregnancy and Postpartum?

A Phase 2/3 interventional study of EPA-rich fish oil supplement and DHA-rich fish oil supplement in Depression, sponsored by University of Michigan. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-28.

Sponsored by University of Michigan · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Depression
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 126 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
126 participants (actual)

Study arms

  • Active comparator
    EPA-rich fish oil supplement

    EPA-rich fish oil supplement

    Drug: EPA-rich fish oil supplement

  • Active comparator
    DHA-rich fish oil supplement

    DHA-rich fish oil supplement

    Drug: DHA-rich fish oil supplement

  • Placebo comparator
    Soy Oil placebo

    Soy oil

    Drug: placebo

Interventions

  • DrugEPA-rich fish oil supplement

    1060 mg EPA plus 274 mg DHA

    Also known as: ProEPA Xtra

  • DrugDHA-rich fish oil supplement

    900 mg DHA plus 180 mg EPA

    Also known as: ProDHA

  • Drugplacebo

    control arm

06

What researchers measure

Primary outcomes

  1. 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.)

    Time frame: 6 - 8 weeks postpartum

Other outcomes

  1. Maternal Outcomes

    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.

    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

  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

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

    Time frame: immediately after birth

  5. NICU (Neonatal Intensive Care Unit) Admissions

    Admission to the NICU

    Time frame: 6 weeks post delivery

  6. One Minute Apgar Score

    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.

    Time frame: 1 minute after birth

  7. Five Minute Apgar Score

    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.

    Time frame: 5 minutes after birth

  8. Cord Arterial pH

    Arterial blood gas analysis of umbilical cord blood

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

07

Results

Posted Apr 28, 2017

Participant flow

Participant flow — Overall Study
MilestoneEPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil Placebo
Started424242
Completed393841
Not completed341
Withdrew: Lost to follow-up341

Outcome measures

PrimaryBeck 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.)

Time frame:
6 - 8 weeks postpartum
Reported as:
Mean · units on a scale
Beck Depression Inventory
units on a scaleEPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil Placebo
BDI at 24-28 weeks' gestation7.9 ± 3.76.5 ± 4.76.3 ± 4.1
BDI at 34-36 weeks' gestation7.4 ± 5.05.9 ± 4.97.2 ± 5.2
BDI at 6-8 weeks postpartum6.6 ± 5.25.1 ± 4.46.2 ± 6.5
Statistical analysis
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · ANOVA · p = .29
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · ANOVA · p = .51
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · ANOVA · p = .56
Other pre-specifiedMaternal Outcomes

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.

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
Reported as:
Number · participants
Maternal Outcomes
participantsEPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil Placebo
Gestational Hypertension or Preeclampsia825
Gestational Diabetes Mellitus712
Induced Labor15128
Cesarean Section101211
Spontaneous Vaginal Delivery252528
Operative Vaginal Delivery411
Statistical analysis
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · Fisher Exact · p = .06
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · Fisher Exact · p = .12
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · Fisher Exact · p = .20
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · Fisher Exact · p = .08
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · Fisher Exact · p = .88
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · Fisher Exact · p = .32
Other pre-specifiedGestational Age at Delivery (Weeks)
Time frame:
delivery date was assessed by medical record review between 1 day and 8 weeks after delivery
Reported as:
Mean · weeks
Gestational Age at Delivery (Weeks)
weeksEPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil Placebo
Gestational Age at Delivery (Weeks)39.1 ± 1.540.4 ± 0.939.1 ± 1.5
Statistical analysis
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · ANOVA · p = <.0001
Other pre-specifiedEstimated Blood Loss (ml)
Time frame:
Within 24 hours after delivery
Reported as:
Mean · mL
Estimated Blood Loss (ml)
mLEPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil Placebo
Estimated Blood Loss (ml)507 ± 481508 ± 325454 ± 296
Statistical analysis
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · ANOVA · p = .81
Other pre-specifiedNeonatal Birthweight

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

Time frame:
immediately after birth
Reported as:
Mean · grams
Neonatal Birthweight
gramsEPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil Placebo
Neonatal Birthweight3402 ± 5503774 ± 4383309 ± 555
Statistical analysis
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · ANOVA · p = <.001Kruskal-Wallis test was used for outliers; Tukey multiple comparisons test was also used.
Other pre-specifiedNICU (Neonatal Intensive Care Unit) Admissions

Admission to the NICU

Time frame:
6 weeks post delivery
Reported as:
Count of participants · Participants
NICU (Neonatal Intensive Care Unit) Admissions
ParticipantsEPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil Placebo
NICU (Neonatal Intensive Care Unit) Admissions624
Statistical analysis
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · ANOVA · p = .39
Other pre-specifiedOne Minute Apgar Score

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.

Time frame:
1 minute after birth
Reported as:
Mean · units on a scale
One Minute Apgar Score
units on a scaleEPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil Placebo
One Minute Apgar Score7.3 ± 2.27.9 ± 1.87.9 ± 1.9
Statistical analysis
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · ANOVA · p = .19
Other pre-specifiedFive Minute Apgar Score

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.

Time frame:
5 minutes after birth
Reported as:
Mean · units on a scale
Five Minute Apgar Score
units on a scaleEPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil Placebo
Five Minute Apgar Score8.6 ± 0.89.1 ± 0.28.9 ± 0.5
Statistical analysis
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · ANOVA · p = <0.01
Other pre-specifiedCord Arterial pH

Arterial blood gas analysis of umbilical cord blood

Time frame:
Immediately after birth (collected within the first hour after delivery)
Reported as:
Mean · pH
Cord Arterial pH
pHEPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil Placebo
Cord Arterial pH7.26 ± 0.097.27 ± 0.057.27 ± 0.06
Statistical analysis
  • EPA-rich Fish Oil Supplement vs DHA-rich Fish Oil Supplement vs Soy Oil Placebo · ANOVA · p = 0.54

Adverse events

Collected over Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
EPA-rich Fish Oil Supplement—8/42 (19%)28/42 (66.7%)
DHA-rich Fish Oil Supplement—5/42 (11.9%)23/42 (54.8%)
Soy Oil Placebo—5/42 (11.9%)22/42 (52.4%)
Most frequent serious events
Most frequent serious events
EventEPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil Placebo
Neonatal ICU AdmissionPregnancy, puerperium and perinatal conditions6/402/384/41
Postpartum hemorrhagePregnancy, puerperium and perinatal conditions2/423/420/42
Premature DeliveryPregnancy, puerperium and perinatal conditions0/421/420/42
late miscarriagePregnancy, puerperium and perinatal conditions0/421/420/42
Preterm premature rupture of membranesPregnancy, puerperium and perinatal conditions0/420/421/42
Maternal ICU admissionPregnancy, puerperium and perinatal conditions1/420/420/42
Most frequent other events
Most frequent other events
EventEPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil Placebo
BelchingGastrointestinal disorders11/4214/4212/42
Infant JaundiceBlood and lymphatic system disorders9/403/382/41
AftertasteGastrointestinal disorders7/428/427/42
Gestational DiabetesEndocrine disorders5/420/421/42
Loose stoolsGastrointestinal disorders5/422/425/42
mastitisReproductive system and breast disorders0/424/420/42
nauseaGastrointestinal disorders4/421/422/42
Preterm ContractionsReproductive system and breast disorders4/424/421/42
HeartburnGastrointestinal disorders3/420/421/42

Baseline characteristics

All intent to treat - (all but lost to follow up) are included in baseline measures

Age, Continuous
Age, Continuous(years)EPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil PlaceboTotal
Mean29.9 ± 5.030.6 ± 4.530.4 ± 5.930.3 ± 5.18
Sex: Female, Male
Sex: Female, Male(Participants)EPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil PlaceboTotal
Female393841118
Male0000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)EPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil PlaceboTotal
White33293496
African-American44210
Hispanic-Latina0437
Asian1113
American Indian or Alaska Native0011
Native Hawaiian or other Pacific ethnicity1001
Region of Enrollment
Region of Enrollment(Participants)EPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil PlaceboTotal
United States393841118
Gestational age at enrollment
Gestational age at enrollment(weeks)EPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil PlaceboTotal
Mean15.9 ± 2.617 ± 2.316.2 ± 2.316.36 ± 2.4
Parity
Parity(number of previous deliveries)EPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil PlaceboTotal
Mean0.87 ± 0.831.08 ± 0.940.85 ± 1.200.93 ± 1.01
Past history of depression(self reported)
Past history of depression(self reported)(participants)EPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil PlaceboTotal
Number32303395
BDI (Beck Depression Inventory) score
BDI (Beck Depression Inventory) score(units on a scale)EPA-rich Fish Oil SupplementDHA-rich Fish Oil SupplementSoy Oil PlaceboTotal
Mean8.41 ± 5.657.79 ± 5.297.15 ± 5.217.72 ± 5.38

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • University of Michigan Hospital
    Ann Arbor, Michigan 48109, United States
09

References and documents

Publications

  • Mozurkewich E, Chilimigras J, Klemens C, Keeton K, Allbaugh L, Hamilton S, Berman D, Vazquez D, Marcus S, Djuric Z, Vahratian A. The mothers, Omega-3 and mental health study. BMC Pregnancy Childbirth. 2011 Jun 22;11:46. doi: 10.1186/1471-2393-11-46. PubMed 21696635 ↗
  • Mozurkewich EL, Greenwood M, Clinton C, Berman D, Romero V, Djuric Z, Qualls C, Gronert K. Pathway Markers for Pro-resolving Lipid Mediators in Maternal and Umbilical Cord Blood: A Secondary Analysis of the Mothers, Omega-3, and Mental Health Study. Front Pharmacol. 2016 Sep 7;7:274. doi: 10.3389/fphar.2016.00274. eCollection 2016. PubMed 27656142 ↗
  • Williams JA, Romero VC, Clinton CM, Vazquez DM, Marcus SM, Chilimigras JL, Hamilton SE, Allbaugh LJ, Vahratian AM, Schrader RM, Mozurkewich EL. Vitamin D levels and perinatal depressive symptoms in women at risk: a secondary analysis of the mothers, omega-3, and mental health study. BMC Pregnancy Childbirth. 2016 Aug 3;16(1):203. doi: 10.1186/s12884-016-0988-7. PubMed 27485050 ↗
  • Romero VC, Somers EC, Stolberg V, Clinton C, Chensue S, Djuric Z, Berman DR, Treadwell MC, Vahratian AM, Mozurkewich E. Developmental programming for allergy: a secondary analysis of the Mothers, Omega-3, and Mental Health Study. Am J Obstet Gynecol. 2013 Apr;208(4):316.e1-6. doi: 10.1016/j.ajog.2013.01.024. PubMed 23531329 ↗
  • Mozurkewich EL, Clinton CM, Chilimigras JL, Hamilton SE, Allbaugh LJ, Berman DR, Marcus SM, Romero VC, Treadwell MC, Keeton KL, Vahratian AM, Schrader RM, Ren J, Djuric Z. The Mothers, Omega-3, and Mental Health Study: a double-blind, randomized controlled trial. Am J Obstet Gynecol. 2013 Apr;208(4):313.e1-9. doi: 10.1016/j.ajog.2013.01.038. PubMed 23531328 ↗
  • Ren J, Mozurkewich EL, Sen A, Vahratian AM, Ferreri TG, Morse AN, Djuric Z. Total Serum Fatty Acid Analysis by GC-MS: Assay Validation and Serum Sample Stability. Curr Pharm Anal. 2013;9(4):331-339. doi: 10.2174/1573412911309040002. PubMed 25110470 ↗
  • Berman D, Clinton C, Limb R, Somers EC, Romero V, Mozurkewich E. Prenatal Omega-3 Supplementation and Eczema Risk among Offspring at Age 36 Months. Insights Allergy Asthma Bronchitis. 2016;2(1):1. doi: 10.21767/2471-304X.100014. Epub 2016 Apr 10. PubMed 28649675 ↗
  • England JA, Jain J, Holbrook BD, Schrader R, Qualls C, Mozurkewich E. Effect of prenatal EPA and DHA on maternal and cord blood insulin sensitivity: a secondary analysis of the mothers, omega 3, and mental health study. BMC Pregnancy Childbirth. 2019 Nov 29;19(1):452. doi: 10.1186/s12884-019-2599-6. PubMed 31783739 ↗
  • Mozurkewich EL, Berman DR, Vahratian A, Clinton CM, Romero VC, Chilimigras JL, Vazquez D, Qualls C, Djuric Z. Effect of prenatal EPA and DHA on maternal and umbilical cord blood cytokines. BMC Pregnancy Childbirth. 2018 Jun 26;18(1):261. doi: 10.1186/s12884-018-1899-6. PubMed 29940888 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00711971
Lead sponsor
University of Michigan
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Responsible party
Ellen Mozurkewich (Adjunct Assistant Professor, University of Michigan) — Principal investigator
First posted
Jul 9, 2008
Start date
Sep 2008
Primary completion
Aug 2012
Completion
Jan 2013
Results posted
Apr 28, 2017
Last update
Apr 28, 2017

Study contacts

Ellen Mozurkewich, MD, MS
principal investigator · University of Michigan

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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