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Does Fish Oil Prevent Depression in Pregnancy and Postpartum?

Primary Purpose

Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EPA-rich fish oil supplement
DHA-rich fish oil supplement
placebo
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

EPA-rich fish oil supplement

DHA-rich fish oil supplement

Soy Oil placebo

Arm Description

EPA-rich fish oil supplement

DHA-rich fish oil supplement

Soy oil

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

Full Information

First Posted
July 7, 2008
Last Updated
March 17, 2017
Sponsor
University of Michigan
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00711971
Brief Title
Does Fish Oil Prevent Depression in Pregnancy and Postpartum?
Official Title
Does EPA or DHA Prevent Depressive Symptoms in Pregnancy and Postpartum?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EPA-rich fish oil supplement
Arm Type
Active Comparator
Arm Description
EPA-rich fish oil supplement
Arm Title
DHA-rich fish oil supplement
Arm Type
Active Comparator
Arm Description
DHA-rich fish oil supplement
Arm Title
Soy Oil placebo
Arm Type
Placebo Comparator
Arm Description
Soy oil
Intervention Type
Drug
Intervention Name(s)
EPA-rich fish oil supplement
Other Intervention Name(s)
ProEPA Xtra
Intervention Description
1060 mg EPA plus 274 mg DHA
Intervention Type
Drug
Intervention Name(s)
DHA-rich fish oil supplement
Other Intervention Name(s)
ProDHA
Intervention Description
900 mg DHA plus 180 mg EPA
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
control arm
Primary Outcome Measure Information:
Title
Beck Depression Inventory
Description
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 Pre-specified Outcome Measures:
Title
Maternal Outcomes
Description
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
Title
Gestational Age at Delivery (Weeks)
Time Frame
delivery date was assessed by medical record review between 1 day and 8 weeks after delivery
Title
Estimated Blood Loss (ml)
Time Frame
Within 24 hours after delivery
Title
Neonatal Birthweight
Description
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
Title
NICU (Neonatal Intensive Care Unit) Admissions
Description
Admission to the NICU
Time Frame
6 weeks post delivery
Title
One Minute Apgar Score
Description
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
Title
Five Minute Apgar Score
Description
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
Title
Cord Arterial pH
Description
Arterial blood gas analysis of umbilical cord blood
Time Frame
Immediately after birth (collected within the first hour after delivery)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Mozurkewich, MD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21696635
Citation
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.
Results Reference
background
PubMed Identifier
27656142
Citation
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.
Results Reference
result
PubMed Identifier
27485050
Citation
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.
Results Reference
result
PubMed Identifier
23531329
Citation
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.
Results Reference
result
PubMed Identifier
23531328
Citation
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.
Results Reference
result
PubMed Identifier
25110470
Citation
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.
Results Reference
result
PubMed Identifier
28649675
Citation
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.
Results Reference
result
PubMed Identifier
31783739
Citation
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.
Results Reference
derived
PubMed Identifier
29940888
Citation
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.
Results Reference
derived

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Does Fish Oil Prevent Depression in Pregnancy and Postpartum?

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