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临床试验/NCT04806230
NCT04806230已完成不适用

Serum Concentrations of Antidepressant Drugs in Pregnant Women - a Naturalistic Study

Linkoeping University1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2011年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
81
试验地点
1
主要终点
Serum concentrations of drugs and metabolites

研究概览

简要总结

The study was a prospective naturalistic PK study of five frequently used antidepressant drugs in pregnant women; citalopram (CIT), escitalopram (ECIT), sertraline (SERT), mirtazapine (MIRT) and venlafaxine VEN) and their major metabolites (Table 1). After signing informed consent pregnant women with ongoing antidepressant treatment, regardless of indication, were recruited at nine antenatal care centers in mid- and small cities and villages in the Southeast Sweden between April 2011 and September 2013.

详细描述

Serum samples for the antidepressant drug and metabolite(s) concentrations, albumin and creatinine were collected at the first prenatal appointment and at gestational week 15, 20, 25, 35 and at partus. The time interval between drug intake and sampling was registered in all cases. At partus, a serum samples from the umbilical cord was collected drug concentration was assessed. At the first prenatal appointment a blood sample for analyzing the CYP2D6 and CYP2C19 genotype was also collected. All drug concentration analysis were executed post hoc, after last partus, whereas physiological parameters were part of normal routine sampling. Concomitant medication, weight changes and smoking habits were registered throughout the pregnancies.

Our main findings were that dose corrected serum concentrations of neither sertralin nor citalopram changed during the pregnancy. In addition, concentrations of escitalopram and venlafaxine and their metabolites appeared to be stable throughout pregnancy, even though a linear mixed models statistic calculation could not be done due small number of samples.

Results from previous research on sertraline PK during pregnancy are inconclusive. Two studies suggested decreased levels (Freeman, Sit 2), while one study indicated increased levels (Westin). Previous studies, except for Westin's are, however, limited by small sample sizes (six and eight) and a substantial inter-individual variance.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnancy
  • Ongoing treatment with one of the five studied antidepressants.

排除标准

  • 未提供

研究组 & 干预措施

Observed

干预措施: sertraline, mirtazapine, venlafaxine, citalopram, escitalopram (Drug)

结局指标

主要结局

Serum concentrations of drugs and metabolites

时间窗: 9 months

levels of parent compound and metabolites in serum

次要结局

未报告次要终点

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Erik Nilzén

MD

Linkoeping University

研究点 (1)

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