CORE--Human Subjects

核心B -摘要 事实上，所有现有的针对精神疾病妇女的妊娠结局研究都存在以下问题： 两个关键缺点之一：1）依赖回顾性报告，即使受试者是前瞻性的， 确定，以记录怀孕期间的暴露和疾病过程，以及2）近视的重点是 胎儿暴露于精神药物的影响，尽量控制精神药物的影响 疾病/压力，反之亦然。 核心B（人类受试者核心）的主要目标是克服这些限制， 中心的胎儿和婴儿的结果项目与一个队列的生物学母亲和父亲的婴儿， 怀孕与压力、精神疾病、精神药物和其他 伴随暴露，包括烟草、非处方药等。总之，核心产品 B将是前瞻性收集的胎儿/婴儿暴露于母体精神和精神疾病的纵向指数。 疾病和疾病的治疗，反过来将作为独立的，即，暴露，变量 中心的临床项目。 人类主题核心的具体目标是：1）扩展我们小组在以下方面的丰富经验： 通过实施一项前瞻性研究， 一项对有和无妊娠史的孕妇进行的大样本自然观察性研究 抑郁症和/或焦虑症; 2）获得每个参与者的准确表型特征 使用一组诊断专用评估仪器，3）便于获取生物样本 将在其他中心核心和项目中进行分析，以及4）保持电子 核心中收集的人口统计学、心理测量学和生物学数据的存储库， 导出用于中心项目的统计分析。

CORE B - Abstract Virtually all existing pregnancy outcome studies for women with psychiatric illness have suffered from one of two critical shortcomings: 1) a reliance on retrospective reports, even when subjects are prospectively identified, to document the exposures and course of illness during gestation, and 2) a myopic focus on the effects of fetal exposure to psychotropic medication with minimal effort to control for the effects of psychiatric illness/stress and vice versa. The principal goal of Core B, the Human Subjects Core, is to overcome these limitations and provide the Center's fetal and infant outcome projects with a cohort of biological mothers and fathers of babies with wellcharacterized pregnancies with respect to stress, psychiatric illness, psychotropic medication, and other concomitant exposures including tobacco, over-the-counter remedies, etc. In summary, the product of Core B will be prospectively collected longitudinal indices of fetal/infant exposure to both maternal psychiatric illness and the treatments for illness that will in turn will serve as the independent, i.e., exposure, variables in the Center's clinical projects. The specific aims of the Human Subjects Core are: 1) to extend our group's extensive experience in prospective documentation of the perinatal course of mood and anxiety disorders by implementing a naturalistic observational study of a large sample of pregnant women with and without a history of depression and/or anxiety disorders; 2) to derive an accurate phenotypic characterization of each participant using a battery of diagnosis specific assessment instruments, 3) to facilitate access to biological samples from this cohort that will be analyzed in other Center cores and projects, and 4) to maintain an electronic repository for the demographic, psychometric, and biological data collected in the Core that can be readily exported for statistical analysis in the Center's projects.