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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) 是一种严重的精神疾病，影响着美国 0.5 -1.5% 的人。 BP 的发病年龄是在育龄初期。百分之七十患有高血压的女性在产后会反复发作。持续用药是治疗 BP 的主要方法。尽管在过去十年中，治疗单相抑郁症孕妇的医生可以获得的信息有所增加，但为血压治疗决策提供信息的数据却没有类似的进展。关于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，这些妇女的畸形风险增加，与药物治疗无关。对于患有 BP 或精神分裂症的女性，几乎不存在关于妊娠期非典型抗精神病药物使用的数据。大多数研究并未包括构成当代生殖毒性结果组合的结果测量范围。药理学家已经生成了生理状态改变（肾脏或肝脏疾病）和其他患者亚群（儿童和老年人）的数据。对于妊娠期的类似研究的需求肯定不亚于这些人群。必须获得新的信息来将风险收益决策引导到新的复杂水平。这是一项针对怀孕期间患有血压的女性以及产后第一年母婴的前瞻性观察研究。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）。有关怀孕期间治疗的决定将由妇女在参加研究之前与她的医生（与研究无关）做出。该研究的主要目的是确定一组患有 DSM-IV 定义的血压的孕妇，并：1) 描述人群在怀孕期间和产后第一年的血压病程，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) 定义接受药物治疗和未接受药物治疗的 BP 女性的妊娠和婴儿结局，并将其与未接受药物治疗的无 BP 女性进行比较。将药物的影响与疾病的影响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、30 和 36 周进行血清水平检测，以便对生育期间服用药物的妇女进行水平/剂量比监测。母乳喂养婴儿的 BP 妇女的母婴血清水平也将被检测。 6) 对部分服用锂的女性进行药代动力学 (PK) 研究，锂是我们中心妊娠期间最常用的控制血压的药物，在出生后 20-24 周、32-36 周和 12-16 周时进行。目前尚无此类 PK 数据。