Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed study, sponsored by Weill Medical College of Cornell University.
NCT01385709 is a clinical trial that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 29 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Determine whether the blood levels of lithium or sertraline are affected by different phases of the menstrual cycle.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2008-08 |
| Est. Completion | 2013-08 |
What the finished NCT01385709 record still lists
NCT01385709 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 29 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01385709 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02429557 · 29 participants · Phase 1
Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
- NCT02568878 · 29 participants · Phase 3
Creatine for Depressed Male and Female Methamphetamine Users
- NCT03014401 · 29 participants · NA
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
- NCT03128996 · 29 participants · Phase 1
Reduced Intensity Conditioning and Familial HLA-Mismatched BMT for Non-Malignant Disorders
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia