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

Study Overview
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Brief Summary
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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.

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

Conditions
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Panic Disorder, Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, Social Anxiety Disorder

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sertraline<br>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<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lithium, Sertraline