Clinical trial NCT01385709: The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels
Official title: The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Keywords: Lithium
Sertraline
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2011-06-30
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The specific psychiatric diagnoses anticipated in the subject pool include the conditions that lithium and sertraline are 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: blood levels of lithium or sertraline
timeFrame: 5-9 days after menstrual cycle onset
measure: Fluctuations in symptom severity
timeFrame: 5-9 days after onset of menstrual cycle
measure: blood levels of lithium or sertraline
timeFrame: 5-9 days before onset of next menstrual cycle
measure: Fluctuations in symptom severity
timeFrame: 5-9 days before onset of next menstrual cycle
Secondary outcomes:
measure: Correlations between Symptom Severity and Blood Levels of Drugs
timeFrame: 5-9 days after onset of menstrual cycle
measure: Correlations between Symptom Severity and Blood Levels of Drugs
timeFrame: 5-9 days before onset of next menstrual cycle
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Mallay B Occhiogrosso, M.D.
role: PRINCIPAL_INVESTIGATOR
References: