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Perimenopause-Related Mood and Behavioral Disorders

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 329 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. New version filed on ClinicalTrials.gov
  2. 46 versions Re-verified since Mar 1, 2025, no change to tracked fieldsv283-v328
  3. Enrollment target: 1147 to 1158v282
  4. 2 versions Re-verified since Nov 28, 2024, no change to tracked fieldsv280-v281
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00001231
Lead Sponsor National Institute of Mental Health (NIMH)
Conditions Mood Disorder
Enrollment 1,158 participants
Start Date
Updated on ClinicalTrials.gov