We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Reproductive Function and Mood in Women With Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00183352
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 16, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Bipolar Disorder Mental Health

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.


Study Design

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Reproductive Endocrine Function and Mood Over the Menstrual Cycle of Women Treated for Bipolar Disorder
Study Start Date : January 2004
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
Women with bipolar disorder
2
Women who are healthy controls


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women diagnosed with Bipolar Disorder, between 18-40 years of age, who are currently treated with a mood stabilizing agent for a period of at least 3 months and are not taking birth control pills currently. Participants must be willing to travel to Stanford University (near San Francisco, CA) at their own expense for study visits.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183352


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Natalie L. Rasgon, MD, PhD Department of Psychiatry and Behavioral Sciences, Stanford University
More Information

Additional Information:
Responsible Party: Natalie Rasgon, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00183352     History of Changes
Other Study ID Numbers: R01MH066033 ( U.S. NIH Grant/Contract )
SPO# 28571
DAHBR 96-BHC
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: April 2009

Keywords provided by Natalie Rasgon, Stanford University:
Women
Mood
Menarche
Menstruation

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders