Sertraline for the Prevention of Recurrent Postpartum Depression
Condition: Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine the effectiveness of taking sertraline within 24 hours of giving
      birth in preventing a recurrence of postpartum depression.
    

Detailed description: 
      Depression after pregnancy is called postpartum depression and may be caused by a rapid
      change in hormone levels during and immediately after pregnancy. Researchers believe that it
      is one of the most common complications linked to pregnancy. This type of depression occurs
      in 10 to 15% of women within the first 3 months of giving birth and it can negatively affect
      both mothers and their children. Mothers with postpartum depression may experience low
      energy, difficulty concentrating, irritability, and inability to meet their children's needs
      for love and affection. Research shows that children of mothers with postpartum depression
      may have delays in language development, difficulty with emotional bonding to others,
      behavioral problems, lower activity levels, sleep problems, and distress. Many women who have
      suffered from postpartum depression in the past are worried about a repeat episode with the
      birth of their next baby. This study will determine the effectiveness of taking sertraline
      within 24 hours of giving birth in preventing a recurrence of postpartum depression.

      Participants in this double blind study will initially report to the study site two separate
      times while they are pregnant. At the first visit, which will last approximately 3 hours,
      medical and psychiatric histories will be taken. Blood and urine samples will also be
      collected at this time. At the second visit, which will last approximately 1 hour,
      participants will be randomly assigned to receive either sertraline or placebo for the year
      following childbirth. All participants will then either attend 10 clinic visits, each lasting
      1 hour, or receive 17 phone calls over the course of the first 28 weeks postpartum. Mood
      symptoms and day-to-day functioning will be assessed. If the participant's baby is being
      breastfed, a blood sample will also be taken from the baby at Week 4 postpartum. At Week 12
      postpartum, the baby will wear an actigraph to measure his or her activity for one week. At
      Week 24 postpartum, participants who are not depressed will be randomly assigned to either
      continue on sertraline or taper to placebo over 4 weeks. Those who were originally assigned
      to receive placebo will continue taking placebo for the remainder of the study. Starting at
      Week 29 postpartum, there will be approximately one clinic visit per month for the remainder
      of the year. Participants' functioning, ability to interact with their children, and symptoms
      of depression will be assessed at these visits.
    

Intervention name(s): Sertraline
Intervention type(s): Drug
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Postpartum Depression; Recurrent Depression