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%的个体。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的主要方法。尽管在过去的十年中，医生治疗孕妇单极抑郁症的信息有所增加，但用于决定如何治疗BP的数据却没有同样的进步。怀孕期间使用抗惊厥药物的信息仅来自对癫痫妇女的研究，这些妇女在药物治疗之外出现畸形的风险增加。妊娠期非典型抗精神病药物使用的数据在BP或精神分裂症患者中几乎不存在。大多数研究没有包括包括当代生殖毒性结果组合的结果测量范围。药理学家已经提供了生理状态改变（肾脏或肝脏疾病）和其他患者亚群（儿童和老年人）的数据。对怀孕进行类似研究的需求当然不亚于对这些人群的研究。必须获得新的信息，以将风险-收益决策引导到一个新的复杂水平。本研究是一项前瞻性观察性研究，研究对象为妊娠期BP妇女和产后第一年的母婴对。我们计划招募200名有BP的女性和58名无BP的女性（分别为140名和40名完成者）。怀孕期间的治疗决定将由妇女和她的医生（与研究无关）在研究入组前做出。该研究的主要目的是确定一组患有DSM-IV定义的BP的孕妇，并：1)描述人群在怀孕期间和产后第一年的BP病程，并仔细记录治疗和妊娠时间。2)评估母亲角色以及职业、教育和社会领域的功能。3)定义药物治疗和未药物治疗的BP女性的妊娠和婴儿结局，并将其与未药物治疗的无BP女性进行比较。将药物的影响从疾病中分离出来对于提前进行风险评估至关重要。4)评估婴儿出生后第一年的发育情况。5)在妊娠20、30和36周检测血清水平，以便对在生育期间服用药物的妇女进行水平/剂量比监测。同时还将检测母乳喂养婴儿的BP患者的母婴血清水平。6)对在出生后20- 24周、32-36周和12-16周服用锂（本中心妊娠期最常用的降压药物）的女性亚群进行药代动力学（PK）研究。目前没有这样的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.