Comparative Effectiveness and Safety of Depression Treatments during Pregnancy

怀孕期间抑郁症治疗的比较有效性和安全性

• 批准号: 8505331
• 负责人: Sonia Hernandez-Diaz
• 金额: $ 45.83万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8505331
• 关键词: Comparative; Effectiveness; Safety; Depression; Treatments

DESCRIPTION (PROVIDED BY APPLICANT): Depression affects 10-15% of all pregnant women and many of them are treated with antidepressants such as selective serotonin reuptake inhibitors (SSRIs). However, multiple studies have suggested an association between prenatal exposure to SSRIs and an increased risk of cardiovascular malformations, persistent pulmonary hypertension of the newborn and neonatal withdrawal syndrome. On the other hand, pregnant women with major depression who discontinue antidepressant therapy experience relapse of symptoms more often than those who continue on antidepressants. Because moderate to severe depression require pharmacologic treatment and many pregnancies are unplanned, the clinically relevant questions are 1) which antidepressant or SSRI to recommend for women of childbearing age and 2) whether and when to discontinue treatment during pregnancy. Despite the difficult decisions faced by patients and physicians, sufficient comparative safety and effectiveness information to guide therapeutic decisions for depression during pregnancy is lacking. Our primary objective is to provide direct evidence on the comparative effectiveness and safety of each antidepressant in a vulnerable segment of the population, i.e., low income depressed pregnant women and their children. We hypothesize that not all SSRIs are equal and that discontinuation early in pregnancy might reduce the effectiveness of treatment while reducing some risks. We propose to quantify the risk of maternal and fetal adverse events associated with continuing and discontinuing specific SSRIs during pregnancy. Within the Medicaid Analytic eXtract (MAX), a large population-based claims database linkable to additional obstetrical, birth, and psychiatric records, we will identify a cohort of over 78,000 women on SSRIs before conception who delivered between 2001 and 2007. We will compare the effectiveness and safety of continuing versus discontinuing specific SSRIs during pregnancy. We will apply an innovative combination of propensity score techniques and nested case control analyses and will obtain information from medical records to validate the outcomes and incorporate detailed clinical information, including measures of depression severity. The current proposal is an interdisciplinary collaboration between the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, the Department of Epidemiology at Harvard School of Public Health, and the Perinatal Psychiatry Program at Massachusetts General Hospital.

描述(申请人提供)：抑郁症影响10-15%的所有孕妇，她们中的许多人接受抗抑郁药物治疗，如选择性5-羟色胺再摄取抑制剂(SSRIs)。然而，多项研究表明，产前暴露于SSRIs与心血管畸形、新生儿持续性肺动脉高压和新生儿戒断综合征的风险增加有关。另一方面，患有重度抑郁症的孕妇停止抗抑郁治疗的症状复发的频率高于继续服用抗抑郁药物的孕妇。由于中度到重度抑郁症需要药物治疗，而且许多怀孕都是计划外的，临床上相关的问题是：1)对育龄妇女推荐哪种抗抑郁药或SSRI；2)是否以及何时停止怀孕期间的治疗。尽管患者和医生面临着艰难的决定，但缺乏足够的相对安全性和有效性信息来指导妊娠期抑郁症的治疗决定。我们的主要目标是提供直接证据，证明每种抗抑郁药在人群中的弱势群体，即低收入抑郁孕妇及其子女中的相对有效性和安全性。我们假设并不是所有的SSRI都是平等的，怀孕早期停药可能会降低治疗的有效性，同时降低一些风险。我们建议量化与妊娠期间持续和停止特定SSRI相关的母婴不良事件的风险。在医疗补助分析摘录(MAX)中，我们将识别2001至2007年间怀孕前服用SSRI的超过7.8万名女性的队列。MAX是一个基于人群的大型索赔数据库，可链接到额外的产科、分娩和精神疾病记录。我们将比较妊娠期间继续和停止使用特定SSRIs的有效性和安全性。我们将应用倾向评分技术和嵌套病例对照分析的创新组合，并将从医疗记录中获取信息以验证结果，并纳入详细的临床信息，包括抑郁症严重程度的测量。目前的提案是布里格姆妇女医院的药物流行病学和药物经济学部门、哈佛大学公共卫生学院的流行病学系和马萨诸塞州综合医院的围产期精神病学项目之间的跨学科合作。