Antimanic Use During Pregnancy

怀孕期间使用抗躁狂药

• 批准号: 7493577
• 负责人: KATHERINE L WISNER
• 金额: $ 63.2万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7493577
• 关键词: Acute; Address; Adolescence; Affect; Age of Onset; American; Americas; Anticonvulsants; Antidepressive Agents; Antimanic Agents; Area; Benefits and Risks; Biological Assay; Bipolar Disorder; Birth; Breast Feeding; Caring; Child; Chronic; Chronic Disease; Communities; Complex; Condition; Control Groups; Cytochrome P-450 CYP2D6; Cytochrome P450; DSM-IV; Data; Data Collection; Decision Making; Depressed mood; Development; Diagnosis; Disease; Disease remission; Documentation; Dose; Drops; Drug Evaluation; Drug Kinetics; Drug usage; Elderly; Enrollment; Epilepsy; Evaluation; Evolution; Exposure to; Family; Female of child bearing age; Fetal Death; Fetus; Foundations; Free Will; Frequencies; Genetic; Glucose; Glucose Intolerance; Glucose tolerance test; Goals; Growth; Guidelines; Healthcare; Hepatic; High Risk Woman; Hour; Immunization; Individual; Infant; Infant Care; Infant Development; Investigation; Kidney; Level of Evidence; Life; Lithium; Low Birth Weight Infant; Maintenance Therapy; Manic; Measures; Medical; Mental disorders; Metabolism; Minor; Monitor; Mood Disorders; 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; Prevalence; Process; Professional Education; Psychiatric therapeutic procedure; Psychotic Disorders; Publishing; Range; Rate; Recommendation; Recurrence; Relapse; Relative (related person); Research; Research Infrastructure; Research Personnel; Review Literature; Risk; Risk Assessment; Role; Schizophrenia; Serum; Severities; Sleep; Standards of Weights and Measures; Subgroup; Sum; Symptoms; System; Therapeutic; Therapeutic Uses; Third Pregnancy Trimester; Time; Toxic effect; Training; Umbilical Cord Blood; Unipolar Depression; United States Food and Drug Administration; Visit; Week; Weight Gain; Woman; Work; atypical antipsychotic; base; biopsychosocial; child bearing; cohort; comparison group; depressive symptoms; disorder control; drug relapse; fetal; follow-up; hypomania; improved; infant outcome; malformation; maternal serum; men; neonate; neurobehavioral; nondrug therapy; prevention service; prospective; reproductive; response; social

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(申请人提供)：双相情感障碍(BP)是一种严重的精神疾病，在美国影响0.5%-1.5%的人。BP的发病年龄是在最初的生育年龄。70%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。尽管治疗患有单相抑郁症的孕妇的医生可以获得的信息在过去十年中有所增加，但为BP治疗决策提供信息的数据并没有类似的进展。关于怀孕期间使用抗惊厥药物的信息仅从对癫痫妇女的研究中获得，这些妇女独立于药物治疗而增加了畸形的风险。关于怀孕期间非典型抗精神病药物使用的数据在患有BP或精神分裂症的女性中几乎不存在。大多数研究没有包括构成当代生殖毒性结果组合的一系列结果衡量标准。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。在怀孕期间进行类似研究的必要性肯定不亚于这些人群。必须获得新的信息，以指导风险-收益决策达到一个新的复杂程度。这是一项对怀孕期间患有BP的妇女和产后第一年母婴配对的前瞻性观察研究。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)。关于怀孕期间的治疗将由妇女和她的医生(与研究无关)在研究登记之前做出决定。这项研究的主要目的是确定患有DSM-IV定义的BP的孕妇队列，并：1)描述人群中通过怀孕和产后第一年的BP病程，并仔细记录治疗(S)和妊娠时机。2)评估在母性角色以及职业、教育和社会领域的作用。3)定义患有BP的服药和未服药妇女的妊娠和婴儿结局，并将其与未服药的未服药妇女的结果进行比较。将药物的影响与疾病分开是推进风险评估的关键。4)评估婴儿出生后第一年的发育情况。5)在怀孕20周、30周和36周时进行血清水平监测，以便对生育期间服用药物的妇女进行水平/剂量比监测。还将检测哺乳婴儿的患有BP的妇女的母婴血清水平。6)对孕期服用锂的妇女在20-24周、32-36周和12-16周进行药代动力学(PK)研究。锂是本中心孕期最常用的降压药物。目前没有这样的主键数据。