NCT00580268已完成不适用
Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- psychiatric morbidity
研究概览
简要总结
The purpose of this study is to examine risk factors for relapse of bipolar disorder during pregnancy and the postpartum period. The main goal of this study is to find the risks that may make it more likely for a woman with bipolar disorder to experience a depressive, manic, or hypomanic episode during her pregnancy and the postpartum period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •medically healthy adult women (ages 18-45) fulfilling DSM-IV criteria for bipolar disorder of any type (1 or 2) who are currently pregnant within 14 weeks gestation dated by last menstrual period;
- •euthymic at the time of conception;
- •able to give informed consent and comply with study procedures;
- •have a treating psychiatrist, physician or mental health clinician. Gravid women between the ages of 18 and 45
排除标准
- •active suicidality or homicidality;
- •active substance use disorder with 6 months prior to enrollment, or
- •positive urine drug screen at enrollment.
结局指标
主要结局
psychiatric morbidity
时间窗: 15 months
次要结局
- obstetrical outcomes(6 months)
研究者
Viguera, Adele
MD, Center for Women's Mental Health
Massachusetts General Hospital
研究点 (2)
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