Hormones and mood: a deep dive into perimenopause

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: * Perimenopausal Subjects: * History within the last one year of at least one month with perimenopause-related mood or behavioral disturbances of at least moderate severity - that is, disturbances that are distinct in appearance and associated with a notable degree of functional impairment; * Age 40-65; * History of the onset of menstrual irregularity during the past six months but not greater than one year of amenorrhea (i.e., not postmenopausal); * Biological evidence of a deterioration of normal ovarian activity, specifically, plasma FSH levels persistently elevated (\> 14IU/L) (as recommended by the Stages of Reproductive Aging Workshop criteria (106)) drawn at two week intervals over a period of eight weeks; * No prior estrogen replacement therapy for treatment of perimenopausal physical or emotional symptoms within the last six months; and * In good medical health; * Subjects must be competent to comprehend the purpose of the screening process and to provide written informed consent and be willing to participate in NIMH IRB approved research protocols. * A control group of age-matched perimenopausal women who meet patient selection criteria with the exception of the presence of mood or behavioral disorders will also be sought. * Premenopausal women will be women who meet the following inclusion criteria for the longitudinal study participants: * Regular menstrual cycle function (21-34 days); * Absence of current mood or behavioral disturbance as determined by a structured diagnostic interview; * Plasma gonadotropin levels in pre-perimenopausal range (\<14 IU/L); * In good medical health; and * Medication free. EXCLUSION CRITERIA: * Primary general medical illness (i.e., appears to be causing the mood disorder); * Current antidepressant therapy (since this is a screening protocol for subsequent treatment studies in which participants must be untreated). Antidepressants will not be withheld from participants who need or want them; * Current alcohol or substance abuse or dependence (excluding nicotine) of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups); * Pregnant or lactating women; * Subjects who are unable to provide informed consent. * NIMH employees, staff and their immediate family members will be excluded from the study per NIMH policy.