Mood Disorder Clinical Trial in Bethesda MD
Are you healthy and looking to help advance medical science?
You may be eligible to participate in a mood disorder clinical study, and could be compensated for your time.
Are you healthy and looking to help advance medical science? You may be eligible to participate in a mood disorder clinical study, and could be compensated for your time.
Details for the study
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.