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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Weill Medical College of Cornell University

Current Primary Outcome:

• blood levels of lithium or sertraline [ Time Frame: 5-9 days after menstrual cycle onset ]
  Determine whether the blood levels of lithium or sertraline are affected by different phases of the menstrual cycle.
• Fluctuations in symptom severity [ Time Frame: 5-9 days after onset of menstrual cycle ]
  Determine whether there is a fluctuation in symptom severity during different phases of the menstrual cycle.
• blood levels of lithium or sertraline [ Time Frame: 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.
• Fluctuations in symptom severity [ Time Frame: 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Correlations between Symptom Severity and Blood Levels of Drugs [ Time Frame: 5-9 days after onset of menstrual cycle ]
  Determine whether there is a correlation between blood levels of lithium or sertraline and symptom severity during different phases of the menstrual cycle.
• Correlations between Symptom Severity and Blood Levels of Drugs [ Time Frame: 5-9 days before onset of next menstrual cycle ]
  Determine whether there is a correlation between blood levels of lithium or sertraline and symptom severity during different phases of the menstrual cycle.

Original Secondary Outcome: Same as current

Information By: Weill Medical College of Cornell University

Dates:
Date Received: June 13, 2011
Date Started: August 2008
Date Completion:
Last Updated: February 17, 2017
Last Verified: February 2017