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Reproductive Function and Mood in Women With Bipolar Disorder

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Reproductive Function and Mood in Women With Bipolar Disorder
Official Title  Reproductive Endocrine Function and Mood Over the Menstrual Cycle of Women Treated for Bipolar Disorder
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.

Study Phase
Study Type  Observational
Study Design  Ecologic or Community, Prospective
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Bipolar Disorder
Mental Health
Intervention 
MEDLINE PMIDs
Links 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
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  90
Start Date  January 2004
Completion Date January 2009
Eligibility 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
Gender Female
Ages 18 Years to 40 Years
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Pascale Stemmle, BS, BA     (650) 725-2528     pascale@stanford.edu    
Contact: Heather Kenna, MA     (650) 724-0521     hkenna@stanford.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00183352
Organization ID R01 MH66033
Secondary IDs †† SPO# 28571, DAHBR 96-BHC
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Natalie L. Rasgon, MD, PhD     Department of Psychiatry and Behavioral Sciences, Stanford University    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date February 2008
First Received Date  September 12, 2005
Last Updated Date February 12, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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