Reproductive Function and Mood in Women With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183352
• Other study ID #: R01MH066033
• Secondary ID: R01MH066033SPO#
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: May 14, 2014
• Start date: January 2004
• Est. completion date: July 2008

Study information

• Verified date: April 2009
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder
• Mental Health

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

External Links

•   Click here for more information about the research being conducted at the Behavioral Neuroendocrinology Program at Stanford University