title: The mothers, Omega-3 and mental health study.
abstract: BACKGROUND
  Major depressive disorder (MDD) during pregnancy and postpartum depression are associated with significant maternal and neonatal morbidity. While antidepressants are readily used in pregnancy, studies have raised concerns regarding neurobehavioral outcomes in exposed infants. Omega-3 fatty acid supplementation, most frequently from fish oil, has emerged as a possible treatment or prevention strategy for MDD in non-pregnant individuals, and may have beneficial effects in pregnant women. Although published observational studies in the psychiatric literature suggest that maternal docosahexaenoic acid (DHA) deficiency may lead to the development of MDD in pregnancy and postpartum, there are more intervention trials suggesting clinical benefit for supplementation with eicosapentaenoic acid (EPA) in MDD.
  
  
  METHODS
  The Mothers, Omega-3 and Mental Health study is a double blind, placebo-controlled, randomized controlled trial to assess whether omega-3 fatty acid supplementation may prevent antenatal and postpartum depressive symptoms among pregnant women at risk for depression. We plan to recruit 126 pregnant women at less than 20 weeks gestation from prenatal clinics at two health systems in Ann Arbor, Michigan and the surrounding communities. We will follow them prospectively over the course of their pregnancies and up to 6 weeks postpartum. Enrolled participants will be randomized to one of three groups: a) EPA-rich fish oil supplement (1060 mg EPA plus 274 mg DHA) b) DHA-rich fish oil supplement (900 mg DHA plus 180 mg EPA; or c) a placebo. The primary outcome for this study is the Beck Depression Inventory (BDI) score at 6 weeks postpartum. We will need to randomize 126 women to have 80% power to detect a 50% reduction in participants' mean BDI scores with EPA or DHA supplementation compared with placebo. We will also gather information on secondary outcome measures which will include: omega-3 fatty acid concentrations in maternal plasma and cord blood, pro-inflammatory cytokine levels (IL-1β, IL-6, and TNF-α) in maternal and cord blood, need for and dosage of antidepressant medications, and obstetrical outcomes. Analyses will be by intent to treat.
  
  
  CONCLUSIONS
  This study compares the relative effectiveness of DHA and EPA at preventing depressive symptoms among pregnant women at risk.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  NCT00711971.
authors.affiliation: University of Michigan, Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Ann Arbor, Michigan, USA. mozurk@med.umich.edu
authors.forename: Ellen
authors.initials: E
authors.lastname: Mozurkewich
authors.forename: Julie
authors.initials: J
authors.lastname: Chilimigras
authors.forename: Chelsea
authors.initials: C
authors.lastname: Klemens
authors.forename: Kristie
authors.initials: K
authors.lastname: Keeton
authors.forename: Lucy
authors.initials: L
authors.lastname: Allbaugh
authors.forename: Susan
authors.initials: S
authors.lastname: Hamilton
authors.forename: Deborah
authors.initials: D
authors.lastname: Berman
authors.forename: Delia
authors.initials: D
authors.lastname: Vazquez
authors.forename: Sheila
authors.initials: S
authors.lastname: Marcus
authors.forename: Zora
authors.initials: Z
authors.lastname: Djuric
authors.forename: Anjel
authors.initials: A
authors.lastname: Vahratian
mesh_terms: D000928:Antidepressive Agents / Q000008:administration & dosage; D019052:Depression, Postpartum / Q000178:diet therapy / Q000517:prevention & control*; D003865:Major Depressive Disorder / Q000178:diet therapy / Q000517:prevention & control*; D019587:Dietary Supplements; D004281:Docosahexaenoic Acids / Q000097:blood / Q000627:therapeutic use*; D004311:Double-Blind Method; D015118:Eicosapentaenoic Acid / Q000097:blood / Q000627:therapeutic use*; D005260:Female; D005312:Fetal Blood / Q000378:metabolism; D006801:Humans; D053583:Interleukin-1beta / Q000097:blood; D015850:Interleukin-6 / Q000097:blood; D011247:Pregnancy; D011256:Pregnancy Outcome; D014409:Tumor Necrosis Factor-alpha / Q000097:blood
chemical_list: D000928:Antidepressive Agents; D053583:Interleukin-1beta; D015850:Interleukin-6; D014409:Tumor Necrosis Factor-alpha; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid