Optimizing Medication Management for Mothers With Depression (OPTI-MOM)
研究概览
详细说明
The overarching goal of this The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) funded U54 Obstetric-Fetal Pharmacology Research Center study is to develop evidence to construct guidelines for the optimal use of selective serotonin reuptake inhibitor (SSRI) antidepressants in pregnant women. The progressive changes in plasma SSRI and metabolite concentrations across pregnancy and after birth will be determined in an observational study. Serial evaluations of depressive and anxiety symptoms and side effects will be obtained to evaluate their association with plasma concentrations at monthly intervals during pregnancy and twice post-birth. To assess the subjects' metabolic phenotypes, subjects have the option to receive a probe drug cocktail, which will be given to evaluate the activities of enzymes involved in antidepressant metabolism during the third trimester (when activity change is maximal) compared to the non-pregnant state after birth.
Additionally, the study team will investigate the impact of genomic variability on inter-individual differences in SSRI dosing, plasma concentrations and pharmacodynamics during pregnancy, with a focus on genes involved in the metabolism and elimination of SSRIs, drug transporters responsible for SSRI access to the central nervous system, and genes encoding critical SSRI targets involved in therapeutic efficacy.
Finally, the study team will determine the maternal-fetal plasma concentrations and pharmacogenetic characteristics associated with neonatal SSRI abstinence syndrome. Maternal and fetal genotypes will be assessed for their relationship to SSRI drug concentrations and neonatal abstinence syndrome.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University Asher Center for the Study and Treatment of Depressive Disorders
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh
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Texas
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Galveston、Texas、美国、77555
- University of Texas Medical Branch
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Wisconsin
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Marshfield、Wisconsin、美国
- Marshfield Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age 18-45
- Pregnant, less than or at 18 weeks gestation
- English-speaking
- DSM-IV diagnosis of Major Depressive Disorder (MDD), any subtype
- Medically healthy
- Singleton gestation
- Taking sertraline (Zoloft), fluoxetine (Prozac), or citalopram (Celexa)/escitalopram (Lexapro) and have made the decision to continue this medication throughout pregnancy
Exclusion Criteria:
- DSM-IV diagnosis of bipolar disorder or any psychotic episode
- Substance abuse or dependence in the last 6 months and/or positive urine drug screen
- Primary anxiety disorder without MDD
- EPDS score ≥15, or item 10, self-harm thoughts, is scored 3 "yes, quite often"
- Current use of other therapies for depression, including herbals (such as St. John's Wort)
- Chronic use of drugs for medical disorders except aspirin
- Allergy or adverse reaction to dextromethorphan, omeprazole, midazolam or tolbutamide (exclusion for probe study only; these individuals may still participate in the main study)
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Concentration-to-dose ratio of SSRI in plasma
大体时间:Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
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Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
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次要结果测量
结果测量 |
大体时间 |
---|---|
Edinburgh Postnatal Depression Scale (EPDS) Scores
大体时间:Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
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Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
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Asberg Side Effects Scale
大体时间:Every 4 weeks in pregnancy and at 6 and 14 weeks postpartum
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Every 4 weeks in pregnancy and at 6 and 14 weeks postpartum
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合作者和调查者
调查人员
- 首席研究员:Katherine L. Wisner, M.D., M.S.、Northwestern University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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