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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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Ecologic or Community, Prospective | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Bipolar Disorder Mental Health |
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| Intervention † | |||||||||
| MEDLINE PMIDs | |||||||||
| Links | Click here for more information about the research being conducted at the Behavioral Neuroendocrinology Program at Stanford University ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 90 | ||||||||
| Start Date † | January 2004 | ||||||||
| Completion Date | January 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria for All Participants:
Inclusion Criteria for Bipolar Disorder Participants:
Inclusion Criteria for Healthy Controls:
Exclusion Criteria for All Participants:
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| Gender | Female | ||||||||
| Ages | 18 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| 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 † |
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| 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 | ||||||||