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临床试验/NCT01385709
NCT01385709已完成不适用

The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Fluctuations in symptom severity

研究概览

简要总结

The aim of this study is to determine whether blood levels of lithium or sertraline are affected by different phases of the menstrual cycle and whether there is an effect on psychiatric symptoms. Subjects are seen for two visits: one visit during the luteal phase and one visit during the follicular phase of the menstrual cycle. On each visit, they will fill out a depression, anxiety and mania rating scale. Also at each visit a 20mL blood sample will be drawn to measure progesterone level and either a lithium or sertraline level, depending on which medication the patient takes. The primary hypothesis in this study is that blood levels of lithium and sertraline will be significantly lower in women during the luteal phase of the menstrual cycle than during the follicular phase. Examination will also be made of whether symptoms will increase in severity during the luteal phase as compared to the follicular phase. The investigators expect a negative linear association between symptom severity and blood level, i.e. expect symptom severity to worsen as blood levels of lithium or sertraline decrease.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-40 year old female
  • women currently taking Lithium or Sertraline

排除标准

  • currently pregnant or breastfeeding
  • concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera
  • hepatic or renal disease
  • irregular menstrual cycles.

结局指标

主要结局

Fluctuations in symptom severity

时间窗: 5-9 days before onset of next menstrual cycle

Determine whether there is a fluctuation in symptom severity during different phases of the menstrual cycle.

blood levels of lithium or sertraline

时间窗: 5-9 days before onset of next menstrual cycle

Determine whether the blood levels of lithium or sertraline are affected by different phases of the menstrual cycle.

次要结局

  • Correlations between Symptom Severity and Blood Levels of Drugs(5-9 days before onset of next menstrual cycle)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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