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The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels

Information source: Weill Medical College of Cornell University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: 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

Phase: N/A

Status: Recruiting

Sponsored by: Weill Medical College of Cornell University

Official(s) and/or principal investigator(s):
Mallay B Occhiogrosso, M.D., Principal Investigator, Affiliation: Weill Medical College of Cornell University

Overall contact:
Margareth V Del Cid, MA, Phone: 646-962-8311, Email: mvd2003@med.cornell.edu

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.

Clinical Details

Official title: The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

blood levels of lithium or sertraline

Fluctuations in symptom severity

blood levels of lithium or sertraline

Fluctuations in symptom severity

Secondary outcome:

Correlations between Symptom Severity and Blood Levels of Drugs

Correlations between Symptom Severity and Blood Levels of Drugs

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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.

Locations and Contacts

Margareth V Del Cid, MA, Phone: 646-962-8311, Email: mvd2003@med.cornell.edu

Weill Cornell Medical College, New York, New York 10065, United States; Recruiting
Theresa Nguyen, NP, Sub-Investigator
Additional Information

Weill Cornell Medical College website

Starting date: August 2008
Last updated: June 28, 2011

Page last updated: August 23, 2015

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