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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01385709
• Other study ID #: 0310006393
• Status: Completed
• Phase: N/A
• First received: June 13, 2011
• Last updated: February 17, 2017
• Start date: August 2008
• Est. completion date: August 2013

Study information

• Verified date: February 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Bipolar Affective Disorders
• Bipolar Disorder
• Compulsive Behavior
• Cyclothymic Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Dysthymic Disorder
• Genetic Diseases, X-Linked
• Major Depressive Disorder
• Mood Disorders
• Obsessive-Compulsive Disorder
• Panic Disorder
• Phobic Disorders
• Posttraumatic Stress Disorder
• Premenstrual Dysphoric Disorder
• Psychotic Disorders
• Schizoaffective Disorder
• Social Anxiety Disorder
• Stress Disorders, Post-Traumatic

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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

External Links

•   Weill Cornell Medical College website