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: 8274301
• 负责人: Sonia Hernandez-Diaz
• 金额: $ 45.93万
• 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 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8274301
• 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）：抑郁症影响所有孕妇的10-15％，其中许多抑郁症用抗抑郁药（例如选择性5-羟色胺再摄取抑制剂（SSRIS））进行治疗。然而，多项研究表明，产前暴露于SSRIS与心血管畸形的风险增加，新生儿持续性肺动脉高压和新生儿戒断综合征之间存在关联。另一方面，与继续使用抗抑郁药的患者相比，停止抗抑郁治疗的重度抑郁症的孕妇经历了症状复发的频率。由于中度至重度抑郁需要药理治疗，并且许多怀孕是计划外的，因​​此临床相关的问题是1）针对生育年龄的妇女推荐哪种抗抑郁药或SSRI，以及2）在怀孕期间是否以及何时停止治疗。尽管患者和医生做出了艰难的决定，但缺乏足够的比较安全性和有效性信息来指导怀孕期间抑郁症的治疗决定。我们的主要目标是直接提供有关每种抗抑郁药在脆弱人群中的比较有效性和安全性的直接证据，即低收入的孕妇及其子女。我们假设并非所有的SSRI都相等，并且在怀孕初期停用可能会降低治疗的有效性，同时降低一些风险。我们建议量化与持续和中断怀孕期间的孕产妇和胎儿不良事件的风险。在医疗补助分析提取物（MAX）中，这是一个可与其他产科，出生和精神病记录相关的大型基于人群的索赔数据库，我们将在2001年至2007年之间确定由SSRIS上的78,000多名女性组成的女性。我们将在2001年至2007年之间交付。我们将采用倾向评分技术和嵌套病例控制分析的创新组合，并将从医疗记录中获取信息以验证结果并包含详细的临床信息，包括抑郁症严重程度的测量。目前的提案是Brigham和妇女医院的药物ePidemiology and PharmaCosocoecoponansics，哈佛公共卫生学院的流行病学系与马萨诸塞州围产期精神病学计划之间的跨学科合作。