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| ID | Type | Description | Link |
|---|---|---|---|
| 81-M-0126 |
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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, and/or 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....
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 neuroendocrine/neurophysiologic 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy volunteers | healthy females | ||
| patients | females with menstrually-related mood or behavioral difficulties |
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| Measure | Description | Time Frame |
|---|---|---|
| Standardized cross-sectional rating scales (Beck Depression Inventory, Hamilton Depression and Anxiety Scales, and the Rating Scale for Premenstrual Tension Syndrome), symptom rating scales completed daily, and plasma hormone measures (including... | Standardized cross-sectional rating scales (Beck Depression Inventory, Hamilton Depression and Anxiety Scales, and the Rating Scale for Premenstrual Tension Syndrome), symptom rating scales completed daily, and plasma hormone measures (including neurosteroid levels). | Ongoing |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma ACTH and cortisol response, selected variants in genomic profile (e.g., SNPs) and genome/exome sequencing, metabolomic profiles, and the results of the SCID interviews (e.g. past history of postpartum depression). | Plasma ACTH and cortisol response, selected variants in genomic profile (e.g., SNPs) and genome/exome sequencing, metabolomic profiles, and the results of the SCID interviews (e.g. past history of postpartum depression). |
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The subjects of this study will be women who meet the following criteria:
For subjects with recurrent brief depression:
Age-matched women without mood and behavioral disorders will be recruited.
EXCLUSION CRITERIA for all study participants:
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This study will enroll up to 700 females with menstrually-related mood or behavioral difficulties and 900 healthy volunteers.
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| Name | Affiliation | Role |
|---|---|---|
| Peter J Schmidt, M.D. | National Institute of Mental Health (NIMH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1404717 | Background | Rubinow DR. The premenstrual syndrome. New views. JAMA. 1992 Oct 14;268(14):1908-12. No abstract available. | |
| 9435325 | Background | Schmidt PJ, Nieman LK, Danaceau MA, Adams LF, Rubinow DR. Differential behavioral effects of gonadal steroids in women with and in those without premenstrual syndrome. N Engl J Med. 1998 Jan 22;338(4):209-16. doi: 10.1056/NEJM199801223380401. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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Data will be shared with dbGaP, BTRIS and NIMH Data Archive as determined by the Principal Investigator.
Starting 24 months after final publication
Data will be shared with dbGaP, BTRIS and NIMH Data Archive as determined by the Principal Investigator.
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| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D011293 | Premenstrual Syndrome |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ongoing |
| 7906420 | Background | Bancroft J. The premenstrual syndrome--a reappraisal of the concept and the evidence. Psychol Med. 1993;Suppl 24:1-47. doi: 10.1017/s0264180100001272. |