At a glance
ClinicalIndex Comparison Record- ✓Self-reported depression onset associated with menstrual cycle irregularity or amenorrhea
- ✓Minor depression (3–4 criterion symptoms) or major depression of moderate severity or less, without suicidal ideation; BDI or CES-D score ≥10 on ≥3 of 4 screening visits; 17-item Hamilton Depression score ≥10
- ✓Evidence of perimenopausal reproductive status
- ✓Age 40–60 years
- ✕Severe major depression, suicidal ideation (positive SCID item #9), or functional impairment >moderate severity
- ✕Current antidepressant, psychotropic, hormone replacement therapy, oral contraceptive, or mood-altering medication
- ✕History of ischemic cardiac disease, pulmonary embolism, retinal thrombosis, thrombophlebitis, or thromboembolic risk factors
- ✕Smoking >10 cigarettes per day
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Efficacy of Phytoestrogens and Selective Estrogen Receptor Modulators in Perimenopause-Related Depression
In Brief
A Phase 4 clinical trial evaluating Raloxifene, Rimostil, and 2 other interventions for Perimenopausal Depression and Depression. Completed, enrolled 65 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the effectiveness of the drugs raloxifene and rimostil in treating perimenopause-related depression. Perimenopause-related mood disorders cause significant distress to a large number of women; the demand for effective therapies to treat these mood disorders is considerable. Estradiol replacement therapy (ERT) has demonstrated efficacy in treating perimenopause-related depression. Unfortunately, there are long-term risks associated with ERT. Selective estrogen receptor modulators (SERMS), such as raloxifene, and phytoestrogens, such as rimostil, have estrogen-like properties and may offer a safer alternative to ERT. The effect of SERMS and phytoestrogens on mood and cognitive functioning need to be examined in women with perimenopause-related depression. Participants in this study will undergo a medical history, physical examination, electrocardiogram (EKG), and blood and urine tests. They will then be randomly assigned to receive one of four treatments for 8 weeks: raloxifene pills plus a placebo (an inactive substance) skin patch, rimostil pills plus placebo skin patch, estradiol skin patch plus placebo pills, or placebo patch plus placebo pills. Participants will have clinic visits every 2 weeks. During the visits, blood will be drawn and participants will meet with staff members and complete symptom self-rating scales. A urine and blood sample will be collected at the beginning and end of the study. At the end of the study, participants who received placebo or whose study medication was ineffective will be offered treatment with standard antidepressant medications for 8 weeks. Non-menstruating women will receive progesterone for 10 days to induce menstrual bleeding and shedding of the inner layer of the uterus, which may have been stimulated by the study medications.
Study Details
Timeline
Interventions
60 mg a day orally administered
1000 mg twice a day administered orally
100 microgram per day transdermal estradiol
matched placebo skin patch to transdermal estradiol and matched tablets to either Raloxifene or Rimostil