- Ages Eligible for Study
- 40 years to 60 years
- Genders Eligible for Study
Mood, Behavior, Cognition, Climacteric, Menopause, Perimenopause, Midlife, and Depression
- National Institute of Mental Health (NIMH)
longitudinal study participants:
- Regular menstrual cycle function (21-34 days);
- Absence of current mood or behavioral disturbance as determined by a structured
- Plasma gonadotropin levels in pre-perimenopausal range (<14 IU/L);
- In good medical health; and
- Medication free.
- 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.
The purpose of this study is to investigate mood and behavior changes in the time period surrounding and including menopause. This is an observational study; volunteers who participate will not receive any new or experimental therapies. Controversy exists regarding the relationship between estrogen and progesterone (gonadal steroid) changes and midlife-onset depression. This study will examine the role of gonadal steroids in perimenopausal mood and behavioral disorders. Perimenopausal women with depression symptoms and a control group of healthy perimenopausal volunteers will be compared to identify correlates of the occurrence of depression. Participants with depressive symptoms may also participate in companion studies that will test the antidepressant efficacy of phytoestrogens and selective estrogen receptor modulators (SERMS). A group of younger pre-perimenopausal women with normal menstrual cycle functioning will be followed through menopause in an effort to confirm the association of depression onset with changes in reproductive endocrine functioning.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001231
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland United States
Status: RecruitingContact info For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)800-411-1222xTTY8664111010prpl@cc.nih.gov