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NCT00030147 · ClinicalTrials.gov registry record · Phase 4
Raloxifene and Rimostil for Perimenopause-Related Depression
A Phase 4 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 4
- Development phase
- 65
- Enrollment target
NCT00030147 is a Phase 4 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 65 participants.
The verdict
NCT00030147, a Phase 4 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 65 participants
- Enrollment target
Study 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.
Interventions
- DRUG Transdermal Estradiol
- DRUG Raloxifene
- DRUG Rimostil
- DRUG Placebo skin patch and placebo tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2002-02 |
| Est. Completion | 2015-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00030147
The ClinicalTrials.gov registry entry for NCT00030147 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Transdermal Estradiol is the first listed.
NCT00030147 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00030147 about?
NCT00030147 is a clinical study titled "Raloxifene and Rimostil for Perimenopause-Related Depression". 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 ...
What is the current status of trial NCT00030147?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 65 participants. The study started on 2002-02. Estimated completion is 2015-06.
What interventions are being tested in trial NCT00030147?
The interventions under investigation include: Transdermal Estradiol (DRUG), Raloxifene (DRUG), Rimostil (DRUG), Placebo skin patch and placebo tablets (DRUG).
Who is sponsoring clinical trial NCT00030147?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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