Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082043
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2004-04-28
Brief Title:
Dutasteride to Treat Women With Menstrually Related Mood Disorders
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effects of Dutasteride on Mood HPA Axis and Serum Allopregnanolone Levels in Women With Menstrual-Related Mood Disorders and Controls
Status:
COMPLETED
Status Verified Date:
2016-02-05
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:
This study will explore the effects of dutasteride on mood and the stress response across the menstrual cycle Dutasteride blocks production of neurosteroids-hormones that help regulate the stress response systems These systems may be disturbed in women with menstrually related mood disorders MRMD The effects of the drug will be compared in women with and without MRMD to determine how neurosteroids regulate mood and the stress response across the menstrual cycle Dutasteride is approved by the Food and Drug Administration to treat benign prostatic hyperplasia excess growth of the prostate gland in men
Menstruating women 30 to 45 years of age with and without MRMD may be eligible for this study Candidates are screened with a medical and psychiatric history physical examination screening for symptoms of depression and routine blood and urine tests Participants are required to use barrier contraception condoms or diaphragm during the 3-month study and 6-month follow-up
Participants undergo the following tests and procedures
Dutasteride or placebo treatment Participants receive 1 month of dutasteride and 2 months of placebo Neither the participants nor the investigators know when the subject is taking the active medication or the placebo
Biweekly follow-up visits Every 2 weeks during the 3-month treatment period patients come to the NIH Clinical Center to have blood drawn and to complete mood symptoms ratings
Monthly follow-up visits Participants return to the Clinical Center once a month for 6 months after the end of the treatment period to monitor hormone levels and pregnancy status
Menstruating women 30 to 45 years of age with and without MRMD may be eligible for this study Candidates are screened with a medical and psychiatric history physical examination screening for symptoms of depression and routine blood and urine tests Participants are required to use barrier contraception condoms or diaphragm during the 3-month study and 6-month follow-up
Participants undergo the following tests and procedures
Dutasteride or placebo treatment Participants receive 1 month of dutasteride and 2 months of placebo Neither the participants nor the investigators know when the subject is taking the active medication or the placebo
Biweekly follow-up visits Every 2 weeks during the 3-month treatment period patients come to the NIH Clinical Center to have blood drawn and to complete mood symptoms ratings
Monthly follow-up visits Participants return to the Clinical Center once a month for 6 months after the end of the treatment period to monitor hormone levels and pregnancy status
Detailed Description:
Studies of premenstrual syndrome PMS to date have demonstrated that the syndrome represents an abnormal response to normal physiological events Specifically patients with PMS experience a dysphoric mood state in response to normal luteal phase levels of progesterone and additionally fail to demonstrate the augmentation of the hypothalamic-pituitary-adrenal HPA axis normally seen in the luteal phase A parsimonious explanation for the dysregulation of both mood and HPA axis function in PMS is that both are mediated by abnormal levels of or response to the progesterone neurosteriod metabolite allopregnanolone Both exposure to and withdrawal from allopregnanolone have been shown to precipitate adverse mood states in animal studies presumably consequent to induced conformational changes in the GABAA receptor increased alpha-4 subunit that impair GABA receptor function This impairment of GABA receptor function may also be associated with loss of restraint of HPA axis activity and hence may underlie the luteal phase increases in HPA activity in normal women In this protocol we propose to block conversion of progesterone to allopregnanolone in women with menstrual-related mood disorder MRMD equivalent in most reports to a severe form of PMS called premenstrual dysphoric disorder PMDD and in normal control women We will block progesterone metabolism and hence exposure to allopregnanolone with a newly approved 5 alpha-reductase inhibitor dutasteride We hypothesize the following 1 Elimination of exposure to allopregnanolone in women with MRMD will eliminate dysphoric mood in the luteal phase 2 Elimination of exposure of normal control women to allopregnanolone will eliminate the luteal phase enhancement of stimulated stress axis activity response
These hypotheses if confirmed will increase the precision with which we can dissect the pathophysiological mechanisms involved in MRMD and in menstrual-related stress physiology
In this protocol our study objectives are as follows Primary Objectives 1 Determine whether suppression of neurosteroid synthesis will diminish mood symptoms in women with MRMD 2 Determine if suppression of neurosteroid synthesis will eliminate luteal phase-related increases in stimulated HPA axis activity in control women Secondary Objectives 1 Determine whether differences in response to allopregnanolone account for the divergent effects of menstrual cycle phase on HPA axis activity in patients with MRMD and controls 2 Determine if the Dex-CRH test like the graded stressor treadmill test can reveal the effects of menstrual cycle phase on HPA axis function
These hypotheses if confirmed will increase the precision with which we can dissect the pathophysiological mechanisms involved in MRMD and in menstrual-related stress physiology
In this protocol our study objectives are as follows Primary Objectives 1 Determine whether suppression of neurosteroid synthesis will diminish mood symptoms in women with MRMD 2 Determine if suppression of neurosteroid synthesis will eliminate luteal phase-related increases in stimulated HPA axis activity in control women Secondary Objectives 1 Determine whether differences in response to allopregnanolone account for the divergent effects of menstrual cycle phase on HPA axis activity in patients with MRMD and controls 2 Determine if the Dex-CRH test like the graded stressor treadmill test can reveal the effects of menstrual cycle phase on HPA axis function
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 |
|---|---|---|---|
| 04-M-0139 | None | None | None |