View Clinical Trial (Medical Research Study)
The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10065 |
| Conditions: |
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Bipolar Affective Disorders - Cyclothymic Disorder - Schizoaffective Disorder - Major Depressive Disorder - Dysthymic Disorder - Obsessive-Compulsive Disorder - Panic Disorder - Posttraumatic Stress Disorder - Premenstrual Dysphoric Disorder - Social Anxi |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT01385709 |
| Primary Contact: |
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Principal Investigator
Mallay B Occhiogrosso, M.D.
Weill Medical College of Cornell University
Margareth V Del Cid, MA
Phone: 646-962-8311
Email: mvd2003@med.cornell.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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New York, New York 10065
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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