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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT01385709

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

Study Type:

Observational

Actual Enrollment :

29 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

blood levels of lithium or sertraline [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 [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 [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 [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 Outcome Measures

Correlations between Symptom Severity and Blood Levels of Drugs [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.