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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01385709

Enrollment

Registered

2011-06-30

Start date

2008-08-31

Completion date

2013-08-31

Last updated

2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Lithium, Sertraline

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results