Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472615
Status:
COMPLETED
Last Update Posted:
2009-02-26
First Post:
2007-05-10
Brief Title:
Menstrual Effects On Mood Symptoms in Bipolar Disorder
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Menstrual Effects On Mood Symptoms in Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2009-02
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:
Background and Rationale for Study Estrogen and progesterone are female hormones that regulate the menstrual cycle and likely serve an important role in the regulation of mood Premenstrual Syndrome PMS which affects 75 of healthy women is a cyclic pattern of mild dysphoria and physical discomfort that begin 1-2weeks pre-menses and resolve by 2-3 days post-onset of menses Up to 66 of women with bipolar disorder BD describe premenstrual mood changes that range from mild symptoms to severe worsening that require hospitalization Therefore the hormonal shifts of the menstrual cycle likely influence bipolar symptoms but confirmatory research is lacking
Study questions The primary aims and hypotheses are to characterize bipolar mood symptoms throughout the menstrual cycle and to determine if women with BD have 1 a increased severity and persistence of depression and mania symptoms in the late luteal premenstrual vs early follicular phase b larger change in mood symptoms from the late luteal premenstrual to the early follicular phase compared to healthy women 2 more relapses in the late luteal compared to the early follicular phase The secondary aims are to determine 1 frequency and severity of premenstrual dysphoric disorder PMDD type symptoms in bipolar women 2 association between bipolar mood variability and a menstrual phase b ovulatory vs anovulatory cycles c antimanic drug treatment
Study questions The primary aims and hypotheses are to characterize bipolar mood symptoms throughout the menstrual cycle and to determine if women with BD have 1 a increased severity and persistence of depression and mania symptoms in the late luteal premenstrual vs early follicular phase b larger change in mood symptoms from the late luteal premenstrual to the early follicular phase compared to healthy women 2 more relapses in the late luteal compared to the early follicular phase The secondary aims are to determine 1 frequency and severity of premenstrual dysphoric disorder PMDD type symptoms in bipolar women 2 association between bipolar mood variability and a menstrual phase b ovulatory vs anovulatory cycles c antimanic drug treatment
Detailed Description:
Study Design Women with BD 15 depressed 15 euthymic and 15 healthy women will enter the study Over 3-months subjects undergo monthly visits to assess mood and function at the follicular and luteal phases Ovulation is confirmed with 1 urine dipstick tests to detect ovulation LH surge days8-14 from the onset of menses 2 serum progesterone levels 7-days post-ovulation LH surge Subjects record their mood and physical symptoms on the daily self-report LifeChart and the Daily Rating Form
Study Population Women with Bipolar I or II Disorder between ages 18-45 Primary Outcomes Measures 1 a mood severity - scores on the Structured Interview Guide for the Hamilton Depression Scale SIGHADS for depression Mania Rating Scale MRS for maniahypomania and LifeChart mood ratings depression and maniahypomania for the late luteal and early follicular phases b persistence of symptoms - proportion of days with mildmoderatesevere depression or maniahypomania 2 Relapses - bipolar episodes
Study Population Women with Bipolar I or II Disorder between ages 18-45 Primary Outcomes Measures 1 a mood severity - scores on the Structured Interview Guide for the Hamilton Depression Scale SIGHADS for depression Mania Rating Scale MRS for maniahypomania and LifeChart mood ratings depression and maniahypomania for the late luteal and early follicular phases b persistence of symptoms - proportion of days with mildmoderatesevere depression or maniahypomania 2 Relapses - bipolar episodes
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 |
|---|---|---|---|
| CMRF of the UPMC Health System | None | None | None |