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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01385709
First received: June 13, 2011
Last updated: February 17, 2017
Last verified: February 2017

June 13, 2011
February 17, 2017
August 2008
August 2012   (Final data collection date for primary outcome measure)
  • blood levels of lithium or sertraline [ Time Frame: 5-9 days after menstrual cycle onset ]
    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 ]
    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 ]
    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 ]
    Determine whether there is a fluctuation in symptom severity during different phases of the menstrual cycle.
Same as current
Complete list of historical versions of study NCT01385709 on ClinicalTrials.gov Archive Site
  • Correlations between Symptom Severity and Blood Levels of Drugs [ Time Frame: 5-9 days after onset of menstrual cycle ]
    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 ]
    Determine whether there is a correlation between blood levels of lithium or sertraline and symptom severity during different phases of the menstrual cycle.
Same as current
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The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels
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 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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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
Whole blood will be drawn.
Non-Probability Sample
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.
  • 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
Not Provided
  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
August 2013
August 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01385709
0310006393
No
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Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Mallay B Occhiogrosso, M.D. Weill Medical College of Cornell University
Weill Medical College of Cornell University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP