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Reproductive Function and Mood in Women With Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00183352
First received: September 12, 2005
Last updated: April 28, 2009
Last verified: April 2009
History of Changes
  Purpose

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
Bipolar Disorder
Mental Health

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 90
Study Start Date: January 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Women with bipolar disorder
2
Women who are healthy controls

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183352

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
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:
Click here for more information about the research being conducted at the Behavioral Neuroendocrinology Program at Stanford University  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Natalie Rasgon, MD, PhD, National Institutes of Mental health
ClinicalTrials.gov Identifier: NCT00183352     History of Changes
Other Study ID Numbers: R01 MH066033, SPO# 28571, DAHBR 96-BHC
Study First Received: September 12, 2005
Last Updated: April 28, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Women
Mood
Menarche
Menstruation

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013