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临床试验/NCT00276900
NCT00276900已完成3 期

Prevention of Recurrent Postpartum Depression

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2003年12月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
300
试验地点
2
主要终点
Depressive symptoms (measured at Weeks 24 and 52 postpartum)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Presents by week 36 gestation for first two study visit interviews (interviews may be combined)
  • History of DSM-IV Major Depression after the age of 15
  • Score no higher than 19 on the 29-item SIGH-ADS at Week 36
  • Medically healthy, as determined by a physician
  • Exclusion criteria
  • Current major depression
  • Urine screen positive for drugs
  • Currently using other therapies for depression
  • DSM-IV diagnoses of bipolar 1 or 2 disorder or any psychotic episode
  • History of substance abuse within 6 months prior to study entry
  • Has not received any obstetrical care
  • Use of medications for medical disorders (except for treatment of stable disorders)

排除标准

  • 未提供

结局指标

主要结局

Depressive symptoms (measured at Weeks 24 and 52 postpartum)

次要结局

  • Functioning (measured at Weeks 24 and 52 postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katherine Wisner

Professor of Psychiatry, Obstetrics and Gynecology and Reproductive Sciences, Epidemiology and Women's Studies

University of Pittsburgh

研究点 (2)

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