Reproductive Function and Mood in Women With Bipolar Disorder

Stanford University

Status: Completed

Conditions: Bipolar Disorder; Mental Health

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00183352

SPO# 28571

R01MH066033 (U.S. NIH Grant/Contract)

DAHBR 96-BHC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

90 participants in 2 patient groups

1

Description:

Women with bipolar disorder

2

Description:

Women who are healthy controls