Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183352
Status:
COMPLETED
Last Update Posted:
2014-05-16
First Post:
2005-09-12
Brief Title:
Reproductive Function and Mood in Women With Bipolar Disorder
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Reproductive Endocrine Function and Mood Over the Menstrual Cycle of Women Treated for Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAHBR 96-BHC | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH066033 |
| R01MH066033 | NIH | None | None |
| SPO 28571 | None | None | None |