NCT00711971

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for phase_2 depression

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_2 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

April 28, 2017

Completed
Last Updated

April 28, 2017

Status Verified

March 1, 2017

Enrollment Period

3.9 years

First QC Date

July 7, 2008

Results QC Date

November 2, 2016

Last Update Submit

March 17, 2017

Conditions

Depression

Outcome Measures

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.)

    6 - 8 weeks postpartum

Other Outcomes (8)

  • Maternal Outcomes

    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

  • Gestational Age at Delivery (Weeks)

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

  • Estimated Blood Loss (ml)

    Within 24 hours after delivery

  • +5 more other outcomes

Study Arms (3)

EPA-rich fish oil supplement

ACTIVE COMPARATOR

EPA-rich fish oil supplement

Drug: EPA-rich fish oil supplement

DHA-rich fish oil supplement

ACTIVE COMPARATOR

DHA-rich fish oil supplement

Drug: DHA-rich fish oil supplement

Soy Oil placebo

PLACEBO COMPARATOR

Soy oil

Drug: placebo

Interventions

EPA-rich fish oil supplementDRUG

1060 mg EPA plus 274 mg DHA

Also known as: ProEPA Xtra
EPA-rich fish oil supplement
DHA-rich fish oil supplementDRUG

900 mg DHA plus 180 mg EPA

Also known as: ProDHA
DHA-rich fish oil supplement
placeboDRUG

control arm

Soy Oil placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (9)

  • 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.

    PMID: 21696635BACKGROUND

  • 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.

    PMID: 27656142RESULT

  • 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.

    PMID: 27485050RESULT

  • 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.

    PMID: 23531329RESULT

  • 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.

    PMID: 23531328RESULT

  • 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.

    PMID: 25110470RESULT

  • 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.

    PMID: 28649675RESULT

  • 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.

    PMID: 31783739DERIVED

  • 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.

    PMID: 29940888DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Ellen Mozurkewich, Adjunct Assistant Professor
Organization
University of Michigan
emozurkewich@salud.unm.edu
(734) 546-2772

Study Officials

  • Ellen Mozurkewich, MD, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Assistant Professor

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 9, 2008

Study Start

September 1, 2008

Primary Completion

August 1, 2012

Study Completion

January 1, 2013

Last Updated

April 28, 2017

Results First Posted

April 28, 2017

Record last verified: 2017-03

Locations

US(1)