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NCT01385709 · ClinicalTrials.gov registry record
The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels
A clinical trial, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- 29
- Enrollment target
NCT01385709 is a clinical trial that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 29 participants.
The verdict
NCT01385709 has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- 29 participants
- Enrollment target
Study 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2008-08 |
| Est. Completion | 2013-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01385709
The ClinicalTrials.gov registry entry for NCT01385709 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01385709 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01385709 about?
NCT01385709 is a clinical study titled "The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels". 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 ...
What is the current status of trial NCT01385709?
This trial is currently completed. The enrollment target is 29 participants. The study started on 2008-08. Estimated completion is 2013-08.
Who is sponsoring clinical trial NCT01385709?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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