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Bipolar Affective Disorders | The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels

Bipolar Affective Disorders research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

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 Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

SertralineTherefore, 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.

LithiumTherefore, 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.

Study Status

Completed

Start Date: August 2008

Completed Date: August 2013

Phase: N/A

Type: Observational

Design:

Primary Outcome: blood levels of lithium or sertraline

Secondary Outcome: Correlations between Symptom Severity and Blood Levels of Drugs

Study sponsors, principal investigator, and references

Principal Investigator: Mallay B Occhiogrosso, M.D.

Lead Sponsor: Weill Medical College of Cornell University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01385709

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