Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00183352 |
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: | Ecologic or Community, Prospective |
Official Title: | Reproductive Endocrine Function and Mood Over the Menstrual Cycle of Women Treated for Bipolar Disorder |
Estimated Enrollment: | 90 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | January 2009 |
Groups/Cohorts |
---|
1
Women with bipolar disorder
|
2
Women who are healthy controls
|
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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria for All Participants:
Inclusion Criteria for Bipolar Disorder Participants:
Inclusion Criteria for Healthy Controls:
Exclusion Criteria for All Participants:
Contact: Pascale Stemmle, BS, BA | (650) 725-2528 | pascale@stanford.edu |
Contact: Heather Kenna, MA | (650) 724-0521 | hkenna@stanford.edu |
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Pascale Stemmle, BS, BA 650-725-2528 pascale@stanford.edu | |
Contact: Heather Kenna, MA 650-724-0521 hkenna@stanford.edu | |
Principal Investigator: Natalie L. Rasgon, MD, PhD |
Principal Investigator: | Natalie L. Rasgon, MD, PhD | Department of Psychiatry and Behavioral Sciences, Stanford University |
Responsible Party: | National Institutes of Mental health ( Natalie Rasgon, MD, PhD ) |
Study ID Numbers: | R01 MH66033, SPO# 28571, DAHBR 96-BHC |
Study First Received: | September 12, 2005 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00183352 |
Health Authority: | United States: Federal Government |
Women Mood Menarche Menstruation |
Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Mood Disorders Psychotic Disorders |
Pathologic Processes Disease |