An observational study in Mood Disorder, sponsored by National Institute of Mental Health (NIMH). Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by National Institute of Mental Health (NIMH) · Observational
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.
584 studies on the registry are indexed under Mood Disorders; 117 are open to participants now.
This study's enrollment of 1,569 is above the median of 180 across 145 observational studies indexed under Mood Disorders.
Browse Mood Disorders studies →National Institute of Mental Health (NIMH) is the lead sponsor of 359 studies on the registry; 46 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study will enroll up to 700 females with menstrually-related mood or behavioral difficulties and 900 healthy volunteers.
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:
healthy females
females with menstrually-related mood or behavioral difficulties
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).
Time frame: Ongoing
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).
Time frame: ongoing
Plan to share: Yes — Data will be shared with dbGaP, BTRIS and NIMH Data Archive as determined by the Principal Investigator.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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National Institute of Mental Health (NIMH)