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

Completed

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

• Registration Number: NCT01385709
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-28
• Study First Posted: 2011-06-30
• Primary Completion: 2012-08
• Study Completion: 2013-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States