Reproductive Function and Mood in Women With Bipolar Disorder
Reproductive Function and Mood in Women With Bipolar Disorder
This study will determine the effect of medication for bipolar disorder on the reproductive
 function and whether mood changes occur during the menstrual cycle in women with bipolar
 disorder.
Bipolar disorder is a serious condition that can have devastating effects on social and
 psychological functioning. Evidence suggests that medications for bipolar disorder may
 influence reproduction function among women. This study will determine reproductive function
 and mood changes in women who are currently on medication for bipolar disorder.

 This study will comprise women with bipolar disorder and age- and body mass index
 (BMI)-matched healthy controls. Participants will have their reproductive function and mood
 changes assessed for 3 consecutive menstrual cycles. Daily, participants will report about
 their mood, sleep patterns, life events, and any psychiatric medications; this information
 will be entered into a computerized system named ChronoRecord. In addition, participants will
 measure their basal body temperature and collect their urine every morning to assess for
 ovulation. Blood collection will occur at study entry and between Days 3 and 6 of every
 menstrual cycle to determine levels of reproductive hormones. Participants will be asked to
 fast for 12 hours prior to every blood collection. During the first month of the study, an
 extra study visit will occur. Participants will undergo a physical exam for determination of
 excessive hair growth (hirsutism) and BMI. Additionally, insulin resistance will be measured,
 and participants will be asked to complete a questionnaire that will be used to determine
 their past and current menstrual function, as well as the reproductive and psychiatric
 history of their families.
Inclusion Criteria for All Participants:

 -  Have been menstruating for at least 4 years prior to study entry

 -  Participants must be willing to travel to Stanford University at own expense for study
 visits

 Inclusion Criteria for Bipolar Disorder Participants:

 -  Participants should have a diagnosis of Bipolar I, Bipolar II, or Bipolar not
 otherwise specified (NOS), and be under the treatment of a physician who can be
 contacted in case of an emergency

 -  Current treatment with any mood-stabilizing agent for a period of at least 3 months
 (e.g., divalproex sodium, lithium, other mood stabilizer, or atypical antipsychotic)

 Inclusion Criteria for Healthy Controls:

 -  No past or present diagnosis of mental illness

 Exclusion Criteria for All Participants:

 -  Current alcohol or substance abuse or dependence within 6 months prior to study entry

 -  Meets criteria for another DSM-IV Axis I disorder

 -  Contraceptive steroid use within 3 months prior to study entry

 -  Current use of medication that may affect steroid metabolism

 -  Menopausal

 -  Endocrine disease such as diabetes or hypothyroidism

 -  Uncontrolled medical illness

 -  History of long-term corticosteroid use

 -  Organic mood disorder

 -  Pregnancy or breastfeeding within 3 months prior to study entry