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Completed

NCT Number: NCT01385709

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

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.

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Key information

Conditions

Bipolar Affective Disorders Anxiety Disorders Cyclothymic Disorder Depressive Disorder Depressive Disorder, Major Dysthymic Disorder Major Depressive Disorder Menstruation Disturbances Mental Disorders Mood Disorders Obsessive-Compulsive Disorder Panic Disorder Pathologic Processes Pathological Conditions, Signs and Symptoms Phobia, Social Phobic Disorders Posttraumatic Stress Disorder Premenstrual Dysphoric Disorder Premenstrual Syndrome Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Social Anxiety Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Weill Cornell Medical College

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Jun 30, 2011
Registry last updated
Feb 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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