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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2013-08-31

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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No