Perimenopause-Related Mood and Behavioral Disorders
Completed
Conditions studied: Mood Disorder
In brief
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.
Key facts
- Study ID
- NCT00001231
- Run by
- National Institute of Mental Health (NIMH)
- People needed
- 1158
- Starts
- 1989-03-06
- Last updated by the study team
- 2026-07-14
Who can join
Age: 40 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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