Active Surveillance of the Safety of Antipsychotic Medications in Pregnancy
妊娠期抗精神病药物安全性的主动监测
基本信息
- 批准号:10179605
- 负责人:
- 金额:$ 55.27万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-04-12 至 2026-03-31
- 项目状态:未结题
- 来源:
- 关键词:AccountingAdverse effectsAgeAnimalsAntipsychotic AgentsAreaBipolar DisorderCenters for Disease Control and Prevention (U.S.)ClinicalCohort StudiesCongenital AbnormalityCounselingDataData SourcesDatabasesDiagnosisDiscipline of obstetricsDiseaseEquilibriumEtiologyEvaluationFeedsFetusHealth PersonnelHumanIndividualLeadMarketingMental HealthMental disordersMethodsMothersNeonatalNewborn InfantOutcomePatientsPerinatalPharmaceutical PreparationsPharmacological TreatmentPharmacologyPopulationPostpartum WomenPregnancyPregnant WomenProcessPsychiatric therapeutic procedurePsychiatryPublic HealthRegistriesReportingResearch PersonnelRiskSafetyScanningSchizophreniaSignal TransductionSystemTeratogensTestingTherapeutic Clinical TrialTimeTissuesTreesWomanadverse maternal outcomesadverse outcomeadverse pregnancy outcomebasecase controlcohortcomparativedesigndetection methoddrug structure functionevidence basefetalhealth care service utilizationinterestmaternal outcomematernal riskmedication safetymemberneonatal outcomenovelnovel strategiesoffspringprospectiverelapse riskreproductivescreeningteratogenesistopiramatetreatment riskvaccine safetyvenlafaxine
项目摘要
Mental health conditions are common among pregnant and postpartum women as well as non-pregnant
women of reproductive age. While many patients require pharmacologic treatment, the safety of psychotropic
medications in pregnancy is an area with large evidence gaps. Historically, spontaneous reports, pregnancy
exposure registries, and case-control designs were the main approaches used to evaluate the safety of
psychotropic medications in pregnancy, all of which have well-known limitations. In recent years, the field has
gained much expertise with the conduct of cohort studies nested in large healthcare utilization data. Across all
these designs, studies tend to focus on a single or a few selected adverse pregnancy outcomes, and they are
performed at a single time point many years after the drug has entered the market and has been used by many
pregnant women. To avoid unnecessary exposure of mother and fetus to harmful medications or to avoid
women being unnecessarily deprived of treatments for psychiatric disorders when no harmful effects exist, a
new and systematic approach is needed to generate timely evidence on the safety of psychotropic medications
in pregnancy with respect to all relevant maternal and fetal outcomes.
We will develop and implement a TreeScan based approach to conduct active surveillance of antipsychotic
medication safety in pregnancy. TreeScan is a novel method for drug safety surveillance, which scans
hierarchical trees of specific outcomes as well as groups of clinically related outcomes for associations with the
treatment of interest, while accounting for multiple testing of correlated hypotheses. We will first develop
hierarchical trees for congenital malformations, maternal and other neonatal outcomes based on shared
underlying disease processes, and modify the TreeScan approach to accommodate the unique challenges of
drug safety evaluation in the context of pregnancy. Use of hierarchical trees increases power to detect clinically
related outcomes, which would not be feasible by evaluating individual diagnoses only. We will then implement
TreeScan to evaluate the risks of a broad range of adverse maternal and neonatal outcomes associated with
antipsychotic medications. Antipsychotics are the mainstay of treatment for women with schizophrenia and
bipolar disorder, but little is known regarding their safety profile in pregnancy, especially for the newer
antipsychotics. We will use nationwide cohorts of over 3.5 million publicly and privately insured pregnancies in
the US, nested in healthcare utilization databases that contain rich information on confounders. In the final aim,
we will extend the approach to conduct near real-time prospective, sequential surveillance of newly approved
antipsychotic and other psychotropic medications in order to detect potential safety signals as early as possible
after approval. By providing the necessary information for healthcare providers to make evidence-based
prescribing decisions and to counsel women about the use of specific antipsychotics during pregnancy, the
proposed studies will have an immediate public health impact within the field of perinatal psychiatry.
心理健康状况在怀孕和产后妇女以及非怀孕妇女中很常见
育龄妇女。虽然许多患者需要药物治疗,但精神药物的安全性
妊娠期用药是一个证据缺口很大的领域。历史上,自发报告,妊娠
暴露登记和病例对照设计是用于评价安全性的主要方法。
精神药物在怀孕期间,所有这些都有众所周知的局限性。近年来,该领域
获得了大量的专业知识,进行嵌套在大型医疗保健利用数据中的队列研究。跨所有
这些设计,研究往往集中在一个单一的或少数选定的不良妊娠结局,他们是
在药物进入市场多年后的单个时间点进行,并已被许多人使用
孕妇避免母亲和胎儿不必要地接触有害药物或避免
在没有有害影响的情况下,不必要地剥夺妇女的精神疾病治疗,a
需要一种新的和系统的方法来及时提供关于精神药物安全性的证据
在妊娠期,所有相关的母亲和胎儿的结果。
我们将开发和实施基于TreeScan的方法,以进行抗精神病药物的主动监测。
妊娠期用药安全。TreeScan是一种用于药物安全监测的新方法,
特定结局的分层树以及与
感兴趣的治疗,同时考虑相关假设的多重检验。我们将首先开发
先天性畸形、孕产妇和其他新生儿结局的分层树,
潜在的疾病过程,并修改树扫描方法,以适应独特的挑战,
妊娠期用药安全性评价。使用分层树提高了临床检测能力
相关的结果,这将是不可行的,通过评估个人的诊断只。我们将实施
TreeScan评估与下列因素相关的广泛的不良孕产妇和新生儿结局的风险:
抗精神病药物抗精神病药物是治疗女性精神分裂症的主要药物,
双相情感障碍,但很少有人知道他们在怀孕期间的安全性,特别是对于新生儿
抗精神病药我们将在全国范围内使用超过350万公共和私人保险怀孕的队列,
美国,嵌套在医疗保健利用数据库中,其中包含有关混杂因素的丰富信息。在最后的目标中,
我们将扩大这一方法,对新批准的
抗精神病药物和其他精神药物,以便尽早检测潜在的安全信号
批准后。通过为医疗保健提供者提供必要的信息,
处方决定和咨询妇女在怀孕期间使用特定的抗精神病药物,
拟议的研究将对围产期精神病学领域的公共卫生产生直接影响。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Krista F Huybrechts其他文献
Short-Term Increases in NO2 and O3 Concentrations during Pregnancy and Stillbirth Risk in the U.S.: A Time-Stratified Case-Crossover Study.
美国怀孕期间 NO2 和 O3 浓度的短期增加和死产风险:时间分层病例交叉研究。
- DOI:
- 发表时间:
2024 - 期刊:
- 影响因子:11.4
- 作者:
M. Shupler;Krista F Huybrechts;Michael Leung;Yaguang Wei;Joel Schwartz;Longxiang Li;P. Koutrakis;S. Hernández;Stefania Papatheodorou - 通讯作者:
Stefania Papatheodorou
Emulating a Target Trial of Interventions Initiated During Pregnancy With Healthcare Databases: The Example of COVID-19 Vaccination. The Authors Respond.
利用医疗保健数据库模拟怀孕期间启动的干预措施的目标试验:以 COVID-19 疫苗接种为例。
- DOI:
10.1097/ede.0000000000001710 - 发表时间:
2024 - 期刊:
- 影响因子:5.4
- 作者:
Sonia Hernández;Krista F Huybrechts;Miguel A Hernán - 通讯作者:
Miguel A Hernán
Krista F Huybrechts的其他文献
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{{ truncateString('Krista F Huybrechts', 18)}}的其他基金
TreeScan to Evaluate the Safety of New Drugs in Pediatric Populations
TreeScan 评估新药在儿科人群中的安全性
- 批准号:
10539032 - 财政年份:2022
- 资助金额:
$ 55.27万 - 项目类别:
TreeScan to Evaluate the Safety of New Drugs in Pediatric Populations
TreeScan 评估新药在儿科人群中的安全性
- 批准号:
10673144 - 财政年份:2022
- 资助金额:
$ 55.27万 - 项目类别:
Active Surveillance of the Safety of Antipsychotic Medications in Pregnancy
妊娠期抗精神病药物安全性的主动监测
- 批准号:
10611382 - 财政年份:2021
- 资助金额:
$ 55.27万 - 项目类别:
Active Surveillance of the Safety of Antipsychotic Medications in Pregnancy
妊娠期抗精神病药物安全性的主动监测
- 批准号:
10391510 - 财政年份:2021
- 资助金额:
$ 55.27万 - 项目类别:
In-utero exposure to psychotropic medications and the risk of neurodevelopmental disorders
子宫内接触精神药物和神经发育障碍的风险
- 批准号:
10378117 - 财政年份:2018
- 资助金额:
$ 55.27万 - 项目类别:
In-utero exposure to psychotropic medications and the risk of neurodevelopmental disorders
子宫内接触精神药物和神经发育障碍的风险
- 批准号:
10133474 - 财政年份:2018
- 资助金额:
$ 55.27万 - 项目类别:
In-utero exposure to psychotropic medications and the risk of neurodevelopmental disorders
子宫内接触精神药物和神经发育障碍的风险
- 批准号:
9893923 - 财政年份:2018
- 资助金额:
$ 55.27万 - 项目类别:
Ondansetron and risk of congenital malformations
昂丹司琼和先天性畸形的风险
- 批准号:
9298084 - 财政年份:2017
- 资助金额:
$ 55.27万 - 项目类别:
Improved methods to assess the comparative safety of new psychiatric medications
评估新精神科药物相对安全性的改进方法
- 批准号:
8711562 - 财政年份:2013
- 资助金额:
$ 55.27万 - 项目类别:
Improved methods to assess the comparative safety of new psychiatric medications
评估新精神科药物相对安全性的改进方法
- 批准号:
8581368 - 财政年份:2013
- 资助金额:
$ 55.27万 - 项目类别:
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