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

NCT01385709 | Completed

• 1 other identifier: 0310006393
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Lithium; Sertraline

Outcome Measures

Primary Outcomes (4)

• blood levels of lithium or sertraline

  Determine whether the blood levels of lithium or sertraline are affected by different phases of the menstrual cycle.

  5-9 days after menstrual cycle onset

• Fluctuations in symptom severity

  Determine whether there is a fluctuation in symptom severity during different phases of the menstrual cycle.

  5-9 days after onset of menstrual cycle

• blood levels of lithium or sertraline

  Determine whether the blood levels of lithium or sertraline are affected by different phases of the menstrual cycle.

  5-9 days before onset of next menstrual cycle

• Fluctuations in symptom severity

  Determine whether there is a fluctuation in symptom severity during different phases of the menstrual cycle.

  5-9 days before onset of next menstrual cycle

Secondary Outcomes (2)

• Correlations between Symptom Severity and Blood Levels of Drugs

  5-9 days after onset of menstrual cycle

• Correlations between Symptom Severity and Blood Levels of Drugs

  5-9 days before onset of next menstrual cycle

Study Arms (2)

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 Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• year old female
• women currently taking Lithium or Sertraline

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Links

• Weill Cornell Medical College website

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood will be drawn.

MeSH Terms

Conditions

Cyclothymic Disorder; Psychotic Disorders; Depressive Disorder, Major; Dysthymic Disorder; Obsessive-Compulsive Disorder; Panic Disorder; Stress Disorders, Post-Traumatic; Premenstrual Dysphoric Disorder; Phobia, Social

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Depressive Disorder; Anxiety Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Premenstrual Syndrome; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phobic Disorders

Study Officials

• Mallay B Occhiogrosso, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 30, 2011
• Study Start: August 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2013
• Last Updated: February 20, 2017

Record last verified: 2017-02

Locations

US (1)