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.

Study Overview

• Status: Completed
• Conditions: Schizoaffective Disorder; Obsessive-Compulsive Disorder; Major Depressive Disorder; Posttraumatic Stress Disorder; Social Anxiety Disorder; Panic Disorder; Premenstrual Dysphoric Disorder; Dysthymic Disorder; Cyclothymic Disorder; Bipolar Affective Disorders

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The specific psychiatric diagnoses anticipated in the subject pool include the conditions that lithium and sertraline are indicated to treat, including Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, and Social Anxiety Disorder.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Sertraline; Therefore, patients who are already taking psychotropic medications, and therefore are currently in treatment for a psychiatric illness, will be recruited. The specific psychiatric diagnoses anticipated in the subject pool include the conditions that sertraline is indicated to treat, including Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, and Social Anxiety Disorder. Patients must be female, between the ages of 18-40, taking either sertraline on a daily basis for at least one week. Exclusion criteria include 1) currently pregnant or breastfeeding, 2) concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera, 3) hepatic or renal disease, 4) irregular menstrual cycles.
Lithium; Therefore, patients who are already taking psychotropic medications, and therefore are currently in treatment for a psychiatric illness, will be recruited. The specific psychiatric diagnoses anticipated in the subject pool include the conditions that lithium is indicated to treat, including Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, and Social Anxiety Disorder. Patients must be female, between the ages of 18-40, taking lithium on a daily basis for at least one week. Exclusion criteria include 1) currently pregnant or breastfeeding, 2) concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera, 3) hepatic or renal disease, 4) irregular menstrual cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood levels of lithium or sertraline	Determine whether the blood levels of lithium or sertraline are affected by different phases of the menstrual cycle.	5-9 days after menstrual cycle onset
Fluctuations in symptom severity	Determine whether there is a fluctuation in symptom severity during different phases of the menstrual cycle.	5-9 days after onset of menstrual cycle
blood levels of lithium or sertraline	Determine whether the blood levels of lithium or sertraline are affected by different phases of the menstrual cycle.	5-9 days before onset of next menstrual cycle
Fluctuations in symptom severity	Determine whether there is a fluctuation in symptom severity during different phases of the menstrual cycle.	5-9 days before onset of next menstrual cycle

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Mallay B Occhiogrosso, M.D., Weill Medical College of Cornell University

Publications and helpful links

Helpful Links

• Weill Cornell Medical College website

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: June 13, 2011
• First Submitted That Met QC Criteria: June 28, 2011
• First Posted (Estimate): June 30, 2011

Study Record Updates

• Last Update Posted (Actual): February 20, 2017
• Last Update Submitted That Met QC Criteria: February 17, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Sertraline; Lithium
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Trauma and Stressor Related Disorders; Bipolar and Related Disorders; Menstruation Disturbances; Phobic Disorders; Stress Disorders, Traumatic; Premenstrual Syndrome; Depressive Disorder; Disease; Psychotic Disorders; Obsessive-Compulsive Disorder; Anxiety Disorders; Stress Disorders, Post-Traumatic; Bipolar Disorder; Mood Disorders; Depressive Disorder, Major; Phobia, Social; Panic Disorder; Premenstrual Dysphoric Disorder; Dysthymic Disorder; Cyclothymic Disorder
• Other Study ID Numbers: 0310006393