Antimanic Use During Pregnancy

描述（由申请人提供）：双相情感障碍（BP）是一种严重的精神疾病，影响美国0.5 - 1.5%的人。BP的发病年龄是在最初的生育年龄。70%的患有BP的女性在出生后会反复发作。持续用药是治疗BP的主要手段。尽管在过去的十年里，治疗单相抑郁症孕妇的医生所获得的信息有所增加，但为BP治疗决策提供信息的数据并没有类似的进展。关于妊娠期间使用抗惊厥药的信息仅来自对癫痫女性的研究，这些女性的畸形风险增加，与药物治疗无关。关于妊娠期非典型抗精神病药物使用的数据在BP或精神分裂症女性中几乎不存在。大多数研究未纳入包含生殖毒性结局的当代组合的结局指标范围。药理学家已经为改变的生理状态（肾脏或肝脏疾病）和其他患者亚群（儿童和老年人）提供了数据。在妊娠期进行类似研究的必要性肯定不低于这些人群。必须获得新的信息，以指导风险-受益决策达到新的复杂水平。这是一项对妊娠期BP妇女和产后第一年的母婴对进行的前瞻性观察性研究。我们计划招募200名患有BP的女性和58名没有BP的女性（分别为140名和40名完成者）。妊娠期间的治疗决定将由女性在研究入组前与其医生（与研究无关）一起做出。本研究的主要目的是定义一组患有DSM-IV定义的BP的孕妇，并：1）描述整个妊娠期和产后第一年人群中的BP病程，并仔细记录治疗和妊娠时间。2)评估在母亲角色以及职业、教育和社会领域的作用。3)定义用药和未用药的BP妇女的妊娠和婴儿结局，并将其与未用药的BP妇女进行比较。将药物的影响与疾病分开对于推进风险评估至关重要。4)评估婴儿出生后第一年的发育情况。5)在妊娠20周、30周和36周时进行血清水平测定，以监测在分娩期间服用药物的女性的水平/剂量比。还将测定母乳喂养婴儿的BP妇女的母婴血清水平。6)对在我中心妊娠期间服用锂（最常用的血压管理药物）的女性亚组进行药代动力学（PK）研究，时间为出生后20- 24周、32-36周和12-16周。目前尚无此类PK数据。

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.