Reproductive Function and Mood in Women With Bipolar Disorder

Reproductive Endocrine Function and Mood Over the Menstrual Cycle of Women Treated for Bipolar Disorder

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00183352

Enrollment

Registered

2005-09-16

Start date

2004-01-31

Completion date

2008-07-31

Last updated

2014-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Mental Health

Keywords

Women, Mood, Menarche, Menstruation

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Countries

United States

Outcome results