Clinical trial NCT00711971: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Depression
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2008-07-09
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: 6 - 8 weeks postpartum
Secondary outcomes:
Other outcomes:
measure: Maternal Outcomes
timeFrame: 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
measure: Gestational Age at Delivery (Weeks)
timeFrame: delivery date was assessed by medical record review between 1 day and 8 weeks after delivery
measure: Estimated Blood Loss (ml)
timeFrame: Within 24 hours after delivery
measure: Neonatal Birthweight
timeFrame: immediately after birth
measure: NICU (Neonatal Intensive Care Unit) Admissions
timeFrame: 6 weeks post delivery
measure: One Minute Apgar Score
timeFrame: 1 minute after birth
measure: Five Minute Apgar Score
timeFrame: 5 minutes after birth
measure: Cord Arterial pH
timeFrame: Immediately after birth (collected within the first hour after delivery)
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ellen Mozurkewich, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.