Use of Omega-3 Fatty Acids for Perinatal Depression
Condition: Depression; Depression, Postpartum
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effectiveness of using omega-3 fatty acids to treat women with
      perinatal depression.
    

Detailed description: 
      Depression is the chief cause of disease-associated disability in women. Because of the highs
      and lows during pregnancy through the first year of motherhood, expectant and new mothers are
      particularly prone to depression. Approximately 10% to 15% of women experience perinatal
      depression, which includes depression during pregnancy and/or postpartum depression. Signs of
      perinatal depression include persistent feelings of anxiety, guilt, or hopelessness;
      irregular sleep and appetite patterns; lethargy; disinterest in the infant or family
      activities; excessive irritability and restlessness; thoughts of hurting self or infant;
      inability to concentrate; and lack of enjoyment in previously enjoyed activities. Depression
      occurring during pregnancy and postpartum can have a negative impact on the development and
      health of the baby. Additionally, maternal stress in humans is associated with lower birth
      weights and lower gestational ages at birth. Currently, there is a lack of knowledge on the
      use of antidepressants during pregnancy and postpartum, making this a significant health
      issue. Earlier studies have suggested that a depletion of omega-3 fatty acids during
      pregnancy might be the cause of depression and mood disorders in pregnant women. This study
      will evaluate the effectiveness of using omega-3 fatty acids to treat women with perinatal
      depression.

      Participation in this double-blind study will last about 9 weeks. All participants will
      attend an initial screening visit and subsequent study visits, which will occur bi-weekly
      throughout the treatment phase. During these visits, participants will be asked questions
      about their medical and substance use history, demographic information, and eating behaviors.
      Participants will also complete questionnaires and interviews that will be used to assess
      their mental status, depression levels, marital/partner satisfaction levels,
      social/functional abilities, and overall mood levels. After the initial screening visit,
      eligible participants will be randomly assigned to receive either omega-3 fatty acids or
      placebo capsules. Participants in each group will be required to take four capsules on a
      daily basis for 8 weeks. During this treatment phase, all participants will also attend six
      weekly 30-minute supportive psychotherapy sessions. Blood samples for omega-3 fatty acid
      analysis will be taken on the first and last visits.
    

Intervention name(s): Omega-3 Fatty Acids (EPA plus DHA); Supportive psychotherapy; Placebo
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): Four capsules will be taken daily for 8 weeks.; Supportive psychotherapy will provide education to increase understanding of the condition, guidance on how to cope with depression, and methods on how to improve self-esteem.; Four capsules will be taken daily for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Perinatal Depression; Postpartum Depression; Omega-3 Fatty Acids; Eicosapentaenoic Acid (EPA); Docosahexaenoic Acid (DHA); Pregnancy; Psychotherapy