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Mood Disorder · Observational Study
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed observational study registration investigating the relationship between gonadal steroid changes and mood disorders in perimenopausal women. No results are posted in this registry record; the study design and enrollment are described only. Clinical interpretation cannot proceed until peer-reviewed findings are published.
Observational. Mood Disorder; Female; age from 40 Years; to 65 Years. Intervention: Healthy Women; premenopausal depressed women patients. Compared with: Healthy perimenopausal control group; younger pre-perimenopausal women (historical comparison during transition).. n = 1,158. 1 site: United States.
This is a completed observational study registration investigating the relationship between gonadal steroid changes and mood disorders in perimenopausal women. No results are posted in this registry record; the study design and enrollment are described only. Clinical interpretation cannot proceed until peer-reviewed findings are published.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a completed observational registry record with no reported results; it describes study design and enrollment only, making it unsuitable for clinical inference until outcomes are published.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT00001231). This is a study registration, not published results. Lead sponsor: National Institute of Mental Health (NIMH). Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 1158 participants (ACTUAL). Conditions: Mood Disorder. Primary outcome measures: Standardized cross-sectional rating scales (Beck Depression Inventory, Hamilton Depression and Anxiety Scales, and the Center for Epidemiologic Studies-Depression Scale), symptom rating scales completed daily, and plasma hormone measures (includ... , Ongoing. Brief summary: 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....
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