The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels - Full Text View

Purpose

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.

Condition
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

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Bipolar Disorder Depression Menstruation Mental Disorders Mood Disorders Obsessive-Compulsive Disorder Panic Disorder Post-Traumatic Stress Disorder

Drug Information available for: Lithium carbonate Lithium citrate Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

blood levels of lithium or sertraline [ Time Frame: 5-9 days after menstrual cycle onset ] [ Designated as safety issue: No ]
Determine whether the blood levels of lithium or sertraline are affected by different phases of the menstrual cycle.
Fluctuations in symptom severity [ Time Frame: 5-9 days after onset of menstrual cycle ] [ Designated as safety issue: No ]
Determine whether there is a fluctuation in symptom severity during different phases of the menstrual cycle.
blood levels of lithium or sertraline [ Time Frame: 5-9 days before onset of next menstrual cycle ] [ Designated as safety issue: No ]
Determine whether the blood levels of lithium or sertraline are affected by different phases of the menstrual cycle.
Fluctuations in symptom severity [ Time Frame: 5-9 days before onset of next menstrual cycle ] [ Designated as safety issue: No ]
Determine whether there is a fluctuation in symptom severity during different phases of the menstrual cycle.

Secondary Outcome Measures:

Correlations between Symptom Severity and Blood Levels of Drugs [ Time Frame: 5-9 days after onset of menstrual cycle ] [ Designated as safety issue: No ]
Determine whether there is a correlation between blood levels of lithium or sertraline and symptom severity during different phases of the menstrual cycle.
Correlations between Symptom Severity and Blood Levels of Drugs [ Time Frame: 5-9 days before onset of next menstrual cycle ] [ Designated as safety issue: No ]
Determine whether there is a correlation between blood levels of lithium or sertraline and symptom severity during different phases of the menstrual cycle.

Biospecimen Retention: Samples Without DNA

Whole blood will be drawn.

Estimated Enrollment:	60
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Sertraline Therefore, patients who are already taking psychotropic medications, and therefore are currently in treatment for a psychiatric illness, will be recruited. The specific psychiatric diagnoses anticipated in the subject pool include the conditions that sertraline is indicated to treat, including Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, and Social Anxiety Disorder. Patients must be female, between the ages of 18-40, taking either sertraline on a daily basis for at least one week. Exclusion criteria include 1) currently pregnant or breastfeeding, 2) concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera, 3) hepatic or renal disease, 4) irregular menstrual cycles.
Lithium Therefore, patients who are already taking psychotropic medications, and therefore are currently in treatment for a psychiatric illness, will be recruited. The specific psychiatric diagnoses anticipated in the subject pool include the conditions that lithium is indicated to treat, including Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, and Social Anxiety Disorder. Patients must be female, between the ages of 18-40, taking lithium on a daily basis for at least one week. Exclusion criteria include 1) currently pregnant or breastfeeding, 2) concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera, 3) hepatic or renal disease, 4) irregular menstrual cycles.

Groups/Cohorts

Sertraline

Therefore, patients who are already taking psychotropic medications, and therefore are currently in treatment for a psychiatric illness, will be recruited. The specific psychiatric diagnoses anticipated in the subject pool include the conditions that sertraline is indicated to treat, including Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, and Social Anxiety Disorder. Patients must be female, between the ages of 18-40, taking either sertraline on a daily basis for at least one week. Exclusion criteria include 1) currently pregnant or breastfeeding, 2) concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera, 3) hepatic or renal disease, 4) irregular menstrual cycles.

Lithium

Therefore, patients who are already taking psychotropic medications, and therefore are currently in treatment for a psychiatric illness, will be recruited. The specific psychiatric diagnoses anticipated in the subject pool include the conditions that lithium is indicated to treat, including Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, and Social Anxiety Disorder. Patients must be female, between the ages of 18-40, taking lithium on a daily basis for at least one week. Exclusion criteria include 1) currently pregnant or breastfeeding, 2) concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera, 3) hepatic or renal disease, 4) irregular menstrual cycles.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The specific psychiatric diagnoses anticipated in the subject pool include the conditions that lithium and sertraline are indicated to treat, including Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, and Social Anxiety Disorder.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385709

Contacts

Contact: Margareth V Del Cid, MA

646-962-8311

mvd2003@med.cornell.edu

Locations

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

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator:

Mallay B Occhiogrosso, M.D.

Weill Medical College of Cornell University

More Information

Additional Information:

Weill Cornell Medical College website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mallay Occhiogrosso, M.D./Assistant Attending Psychiatrist/Assistant Professor of Psychiatry, Weill Cornell Medical College
ClinicalTrials.gov Identifier:	NCT01385709 History of Changes
Other Study ID Numbers:	0310006393
Study First Received:	June 13, 2011
Last Updated:	June 28, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

Lithium
Sertraline

Additional relevant MeSH terms:

Anxiety Disorders
Bipolar Disorder
Cyclothymic Disorder
Depressive Disorder
Depression
Dysthymic Disorder
Obsessive-Compulsive Disorder
Panic Disorder
Phobic Disorders
Psychotic Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Depressive Disorder, Major
Premenstrual Syndrome
Mood Disorders

Compulsive Personality Disorder
Mental Disorders
Affective Disorders, Psychotic
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Menstruation Disturbances
Pathologic Processes
Personality Disorders
Lithium
Lithium Carbonate
Sertraline
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013