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临床试验/NCT00279370
NCT00279370已完成不适用

Antidepressant Use During Pregnancy

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 283 人开始时间: 1999年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
283
试验地点
1
主要终点
SIGH-ADS

研究概览

简要总结

This study will determine the safety of antidepressant use during pregnancy for both the mother and the child.

详细描述

Symptoms of major depressive disorder (MDD) include persistent sad mood, feelings of hopelessness or guilt, decreased energy, irritability, and more. If untreated, MDD can interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. MDD occurs most commonly in females between the ages of 25 and 44. This puts women of childbearing age at a particularly high risk for developing the disorder. However, very little research has been done to determine the safety of antidepressant use during pregnancy and how the medication may affect the baby. This study will determine the safety of antidepressant use during pregnancy for both the mother and the child.

Participants in this observational study will not receive medication or treatment of any kind. Pregnant woman who are already taking medication for depression will be recruited, in addition to pregnant women who are not taking any medication. The participants will first undergo interviews to establish their psychiatric diagnoses. Subsequent interviews will be held to monitor levels of depressive symptoms, exposure to other substances that could potentially harm the fetus, levels of antidepressants in the blood, and dietary intake during pregnancy. Participants will report to the study site for these evaluations at Weeks 20, 30, and 36 of pregnancy. From Week 36 to Week 40, interviews will be conducted over the phone.

At birth, cord blood will be collected and the infant's cries will be recorded. The infant's development will be assessed at 2 weeks and 3, 6 ½, 12, 18, and 24 months postpartum. Mothers who take selective serotonin reuptake inhibitors (SSRIs) and are breastfeeding their children will report to the study site with their children at 1 month postpartum to measure the level of SSRIs in the infant's blood. In addition, digital photographs of the infant's face, profile, hands, and torso will be taken at 2 weeks and 3, 12, and 24 months postpartum. Additional face-only photographs of the infant will be taken at these times and at birth for further in-depth analyses of facial characteristics. Mother-child interactions will be videotaped at all postpartum assessments.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Less than 24 weeks pregnant at the time of study entry
  • As of 12/1/2005, at significant risk for developing depression or currently taking SSRIs during pregnancy

排除标准

  • History of or current psychosis, bipolar disorder, or schizoaffective disorder
  • Current substance use disorder
  • Any medical condition that may be related to outcomes (such as multiple births or insulin-dependent diabetes)
  • Has not attended at least two prenatal visits at the 20-week intake point

结局指标

主要结局

SIGH-ADS

时间窗: 20, 30, 36 weeks gestation and 2, 12, 28, 52, and 104 weeks postpartum

Bayley Scales of Infant Development

时间窗: 12, 28, 52, and 104 weeks postpartum

次要结局

未报告次要终点

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 (1)

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