Antimanic Use During Pregnancy

怀孕期间使用抗躁狂药

基本信息

批准号：
7920852
负责人：
KATHERINE L WISNER
金额：
$ 59.58万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-09-01 至 2012-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7920852
关键词：
Address Affect Age of Onset Americas Anticonvulsants Antidepressive Agents Antimanic Agents Area Benefits and Risks Biological Assay Bipolar Disorder Birth Breast Feeding Caring Child Communities Complex Control Groups Cytochrome P-450 CYP2D6 Cytochrome P450 DSM-IV Data Data Collection Decision Making Depressed mood Development Disease Disease remission Documentation Dose Drops Drug Kinetics Drug usage Elderly Enrollment Epilepsy Evaluation Evolution Exposure to Family Female of child bearing age Fetus Free Will Frequencies Glucose Glucose Intolerance Glucose tolerance test Goals Healthcare Hepatic High Risk Woman Hour Immunization Individual Infant Infant Care Infant Development Investigation Kidney Level of Evidence Life Lithium Low Birth Weight Infant Manic Measures Medical Metabolism Minor Monitor Moods Mothers Neonatal Newborn Infant Nortriptyline Observational Study Occupational Orphan Outcome Outcome Measure Patient currently pregnant Patients Pharmaceutical Preparations Pharmacotherapy Physicians Physiological Population Population Study Postpartum Period Postpartum Women Pregnancy Pregnancy Outcome Pregnant Women Premature Birth Process Recurrence Relapse Relative (related person)Research Infrastructure Research Personnel Risk Risk Assessment Role Schizophrenia Serum Severities Subgroup Sum System Therapeutic Third Pregnancy Trimester Time Toxic effect Training Umbilical Cord Blood Unipolar Depression Visit Weight Gain Woman Work atypical antipsychotic base biopsychosocial child bearing cohort comparison group disorder control drug relapse follow-up infant outcome malformation maternal serum neonate nondrug therapy offspring pregnant prevention service prospective reproductive response social

项目摘要

DESCRIPTION (provided by applicant): Bipolar disorder (BP) is a serious psychiatric condition that affects 0.5 -1.5% of individuals in America. The age of onset of BP is during the initial childbearing years. Seventy percent of women with established BP will suffer recurrent episodes post-birth. Continuous medication administration is the mainstay of treatment for BP. Although the information available to physicians who treat pregnant women with unipolar depression has increased over the past decade, data to inform decisions about treatment of BP has not advanced similarly. Information about anticonvulsant use during pregnancy has been garnered solely from the study of women with epilepsy, who have increased risk for malformations independent of drug treatment. Data about atypical antipsychotic use in pregnancy is almost non-existent in either women with BP or schizophrenia. The majority of studies have not included the range of outcome measures that comprise the contemporary portfolio of the reproductive toxicity outcomes. Pharmacologists have produced data for altered physiologic states (renal or hepatic disease) and for other patient subpopulations (children and elderly). The need for similar studies in pregnancy is certainly no less than for these populations. New information must be obtained to guide risk-benefit decision-making to a new level of sophistication. This is a prospective observational study of women with BP during pregnancy and the mother-infant pairs n the first postpartum year. We plan to enroll 200 women with BP and 58 women without BP (for 140 and 40 completers, respectively). Decisions about treatment during pregnancy will be made by the woman with her physician (not associated with the study) prior to study enrollment. The major aims of the study are to define a cohort of pregnant women with DSM-IV defined BP and to: 1) Characterize the BP illness course in the population through pregnancy and the first postpartum year, with careful documentation of treatment(s) and gestational timing. 2) Evaluate function in the maternal role as well as occupational, educational and social domains. 3) Define pregnancy and infant outcomes in both medicated and unmedicated women with BP and compare them to those of unmedicated women without BP. Separation of the effects of medication from the disorder is critical to advance risk assessment. 4) Assess the infants' development through the first year of life. 5) Perform serum levels at 20, 30, and 36 weeks gestation to allow level/dose ratio monitoring for women who take medications during childbearing. The mother-infant serum levels of women with BP who breastfeed their infants also will be assayed. 6) Conduct pharmacokinetic (PK) studies on the subset of women who take lithium, the most common drug used to manage BP during pregnancy in our Center, at 20- 24 weeks, 32-36 weeks, and 12-16 weeks after birth. No such PK data are currently available.

描述（由申请人提供）：双相情感障碍（BP）是一种严重的精神病病，影响了0.5-1.5％的美国个人。 BP的发病年龄是在最初的生育年份。 BP既定的女性中有70％会在出生后复发。连续药物给药是BP治疗的支柱。尽管过去十年来治疗单极抑郁症的孕妇的医生可获得的信息有所增加，但可以为BP治疗的决定提供的数据并未类似地提出。关于怀孕期间使用抗惊厥药的信息仅来自对癫痫的女性的研究，她们的畸形风险与药物治疗无关。在BP或精神分裂症的女性中，关于怀孕中非典型抗精神病药物的数据几乎不存在。大多数研究都不包括构成生殖毒性结果的当代投资组合的结果范围。药理学家已经生成了改变生理状态（肾脏或肝病）以及其他患者亚群（儿童和老年人）的数据。对怀孕的类似研究的需求当然不亚于这些人群。必须获得新的信息，以将风险效益决策指导到新的复杂水平。这是对怀孕期间BP和母亲成对的前瞻性观察性研究。我们计划招募200名BP女性和58名没有BP的女性（分别为140和40个完成者）。在研究入学之前，该妇女与她的医生（与研究无关）将做出有关怀孕期间治疗的决定。该研究的主要目的是定义DSM-IV定义的BP的孕妇队列，至：1）特征是通过怀孕和产后第一年的人群中的BP疾病病程，并仔细地记录治疗和妊娠时间。 2）评估产妇角色以及职业，教育和社会领域的功能。 3）定义具有BP的药物和未药物的妇女的妊娠和婴儿结局，并将其与没有BP的未经药物的妇女进行比较。将药物与疾病的影响分离对于提高风险评估至关重要。 4）在生命的第一年评估婴儿的发育。 5）在妊娠20、30和36周时进行血清水平，以允许监测育儿期间服用药物的女性的水平/剂量比。母乳喂养婴儿的母亲血清水平也将被测定。 6）对服用锂的女性子集进行药代动力学（PK）研究，这是在我们中心在怀孕期间管理BP的最常见药物，在20至24周，32-36周和出生后12-16周。目前没有这样的PK数据。