Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030147
Status:
COMPLETED
Last Update Posted:
2016-09-05
First Post:
2002-02-06
Brief Title:
Raloxifene and Rimostil for Perimenopause-Related Depression
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Efficacy of Phytoestrogens and Selective Estrogen Receptor Modulators in Perimenopause-Related Depression
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Perimenopause-related mood disorders cause significant distress to a potentially large number of women The demand for effective therapeutic alternatives to estrogen for treating these mood disorders is considerable as is the need to define clinical or biologic markers that may predict successful response of mood disturbances to phytoestrogens or selective estrogen receptor modulators SERMs Further the study of potential biological mechanisms underlying both perimenopause-related mood disorders and their response to treatment may offer the possibility of uncovering some etiopathogenic mechanisms involved in these and related mood disorders
Results of protocol 90-M-0077 demonstrated the therapeutic efficacy of estradiol therapy ET in perimenopausal depression independent of its effects on vasomotor symptoms Nevertheless the long term risks of ET to endometrial and breast tissues continue to deter many women from its use Recently selective estrogen receptor modulators SERMs and phytoestrogens plant-derived estrogen-like compounds have become available and are reported to display both tissue-specific profiles of estrogen agonist and antagonist actions and differential affinities for the two forms of estrogen receptor For many women these novel compounds would represent a safer alternative to ET for the prevention of osteoporosis and the treatment of menopausal symptoms However the effects of SERMs and phytoestrogens on mood and cognitive function in perimenopausal women remain undetermined
In this protocol we wish both to investigate the effects of SERMs and phytoestrogens on mood and cognition under placebo controlled conditions and to compare these effects with estradiol therapy This protocol will address the following questions 1 Do selective estrogen receptor modulators or phytoestrogens improve mood and cognition in perimenopausal depressed women 2 Are the mood and cognitive effects of SERMs and phytoestrogens comparable to those of ET and 3 Do selective estrogen receptor modulators and phytoestrogens improve measures of bone metabolism in perimenopausal depressed women
Results of protocol 90-M-0077 demonstrated the therapeutic efficacy of estradiol therapy ET in perimenopausal depression independent of its effects on vasomotor symptoms Nevertheless the long term risks of ET to endometrial and breast tissues continue to deter many women from its use Recently selective estrogen receptor modulators SERMs and phytoestrogens plant-derived estrogen-like compounds have become available and are reported to display both tissue-specific profiles of estrogen agonist and antagonist actions and differential affinities for the two forms of estrogen receptor For many women these novel compounds would represent a safer alternative to ET for the prevention of osteoporosis and the treatment of menopausal symptoms However the effects of SERMs and phytoestrogens on mood and cognitive function in perimenopausal women remain undetermined
In this protocol we wish both to investigate the effects of SERMs and phytoestrogens on mood and cognition under placebo controlled conditions and to compare these effects with estradiol therapy This protocol will address the following questions 1 Do selective estrogen receptor modulators or phytoestrogens improve mood and cognition in perimenopausal depressed women 2 Are the mood and cognitive effects of SERMs and phytoestrogens comparable to those of ET and 3 Do selective estrogen receptor modulators and phytoestrogens improve measures of bone metabolism in perimenopausal depressed women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-M-0120 | OTHER | NIHCC | httpsreporternihgovquickSearchZIAMH002537-26 |
| ZIAMH002537-26 | NIH | None | None |