Raloxifene and Rimostil for Perimenopause-Related Depression
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
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.