Major Depressive Disorder Clinical Trial
Official title:
The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels
Verified date | February 2017 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
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 |
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