Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT00889369
Status:
UNKNOWN
Last Update Posted:
2012-02-08
First Post:
2009-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Duloxetine for Major Depression in Peri-/Postmenopausal Women
Sponsor:
Hamilton Health Sciences Corporation
Organization:
Study Overview
Official Title:
Duloxetine for the Treatment of Major Depression in Midlife Women: Effects on Brain Structure and Functioning, Mood, and Quality of Life
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
RECRUITING
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 main objective of this study is to characterize a range of brain activation symptoms associated with major depression in peri- and post-menopausal women. Also, assessing brain activation before and after the treatment might help to uncover some mechanisms associated with the pathophysiology of depression and menopause.
Detailed Description:
Women approaching menopause and during the post-menopausal years appear to be at greater risk for developing major depressive episodes. Moreover, this period in life has been associated with significant functional impairment due to the presence/severity of vasomotor symptoms (hot flashes, night sweats), cognitive complaints, and poorer quality of life. In light of recent controversies involving the use of hormone therapies, most physicians and patients are seeking nonhormonal strategies to alleviate menopause-related physical and emotional complaints. Duloxetine has been shown to improve major depressive disorder (MDD) and menopause-related symptoms. To date, the effects of this agent on brain structure and functioning in midlife women with MDD have not been explored. The present study aims to investigate the effects of duloxetine on brain structure and functioning when used for the treatment of a major depressive episode in menopausal women using anatomical magnetic resonance imaging (MRI) and functional MRI (fMRI). In addition, the investigators will examine whether the impact of treatment with duloxetine on vasomotor symptoms, cognition, and quality of life modulate the putative changes in brain structure and functioning.
Study Oversight
Has Oversight DMC:
False
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?: