Raloxifene and Rimostil for Perimenopause-Related Depression (NCT00030147) | Clinical Trial Compass
CompletedPhase 4
Raloxifene and Rimostil for Perimenopause-Related Depression
United States65 participantsStarted 2002-02
Plain-language 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.
Who can participate
Age range40 Years – 60 Years
SexFEMALE
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Inclusion criteria
✓. Self-report of the onset of depression associated with menstrual cycle irregularity or amenorrhea;
✓. A current episode of minor (meeting 3-4 criterion symptoms) or major depression (of moderate severity or less on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV (SCID) severity scale and not meeting DSM-IV criteria symptom 9 (suicide)) as determined by the administration of the minor depression module of the Schedule for Affective Disorders and Schizophrenia - Lifetime Version (SADS-L). Additionally, to ensure that subjects meet a minimum threshold for severity of depression, subjects will have scores greater than or equal to 10 on either the Beck Depression Inventory (BDI) or the Center for Epidemiologic Studies - Depression (CES-D) Scale during at least three of the four clinic visits during the two month screening phase, as well as a 17 item Hamilton Depression score greater than or equal to 10. Subjects will be excluded if they meet any of the following criteria: major depression of greater than moderate severity, DSM-IV criteria # 9 (suicide), or anyone requiring immediate treatment after clinical assessment or functional impairment ratings of five or six for more than seven consecutive days on daily ratings;
✓. Evidence of perimenopausal reproductive status;
✓. Age 40 to 60;
✓. No prior hormonal therapy for the treatment of perimenopause-related mood or physical symptoms within the last six months;
✓
What they're measuring
1
Center for Epidemiologic Studies-Depression Scale (CES-D)
Timeframe: Baseline
2
Center for Epidemiologic Studies-Depression Scale (CES-D)
. No history of psychiatric illness during the two years prior to the reported onset of the current episode of depression;
✓. In good medical health, and not taking any medication or dietary and herbal supplements on a regular basis (with the exception of multivitamins and calcium supplements).
Exclusion criteria
✕. positive (threshold) response to SCID major depression section item # 9, suicidal ideation;
✕. anyone requiring immediate treatment after clinical assessment;
✕. severity ratings greater than moderate on the SCID IV interview;
✕. functional impairment ratings of five or six for more than seven consecutive days on daily ratings.