Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001177
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
1999-11-03
Brief Title:
Study of Premenstrual Syndrome and Premenstrual Dysphoria
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Evaluation of Women With Menstrually Regulated Mood and Behavioral Disorders
Status:
RECRUITING
Status Verified Date:
2024-07-01
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:
The purpose of this study is to identify and describe the symptoms of premenstrual syndrome PMS
Women who experience PMS symptoms will complete clinical interviews self-rating scales and evaluations of mood and endocrine function A subgroup of women with severe PMS Premenstrual Dysphoric Disorder or PMDD will be offered additional research studies that focus on 1 identifying the endocrine changes that may be responsible for changes in mood and behavior during the premenstrual period 2 evaluating treatments for PMS symptoms andor 3 identifying genetic factors in women with and without PMS Women with recurrent brief depression will also be recruited to serve as a comparison group
Women who experience PMS symptoms will complete clinical interviews self-rating scales and evaluations of mood and endocrine function A subgroup of women with severe PMS Premenstrual Dysphoric Disorder or PMDD will be offered additional research studies that focus on 1 identifying the endocrine changes that may be responsible for changes in mood and behavior during the premenstrual period 2 evaluating treatments for PMS symptoms andor 3 identifying genetic factors in women with and without PMS Women with recurrent brief depression will also be recruited to serve as a comparison group
Detailed Description:
The purpose of this screening protocol is to identify a population of women who experience menstrually-related mood or behavior difficulties and to describe the symptoms in this group and their relationship to the menses This will be accomplished by means of clinical interviews self-rating scales and periodic evaluation of mood and endocrine function We further wish to identify and recruit a subgroup of women with menstrually-related mood disorder for participation in specific neuroendocrineneurophysiologic studies companion protocols in an attempt to identify endocrinologic or physiologic measures that might 1 be associated with the discrete changes in mood and behavior 2 distinguish this group from a group of age-matched controls 3 allow for further subgroup definition on the basis of predicted response to pharmacological intervention Finally we wish to identify a group of women with recurrent brief depression who will serve as an additional control group for the patients with menstrual cycle-related mood disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 81-M-0126 | None | None | None |