Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women
Information source: McMaster University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder; Menopausal Staging and Vasomotor Symptoms (for Females)
Intervention: Desvenlafaxine Succinate (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Hamilton Health Sciences Corporation Official(s) and/or principal investigator(s): Claudio N Soares, MD, PhD, Principal Investigator, Affiliation: St. Joseph's Healtcare; McMaster University
Overall contact: Stefanie M Attard, Phone: 905-522-1155, Ext: 32048, Email: sattard@stjoes.ca
Summary
The main objective of this study is to characterize a range of brain activation symptoms
associated with depression and response to treatment in midlife men and women with MDD,
using MRI and functional MRI. Moreover, in the female sub-group, the investigators will
examine whether these brain activation symptoms are related to menopausal symptoms (i. e.,
hot flashes and night sweats). Also, assessing brain activation before and after the
treatment might help to uncover some mechanisms associated with the pathophysiology of
depression and menopause.
Clinical Details
Official title: Desvenlafaxine Succinate in Major Depressive Disorder: Effects on Structural and Functional Imaging, Cognition, and Functional Outcomes in Midlife Women and Men
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Effects of desvenlafaxine succinate (DVS) on brain structure and activation in midlife men and women with MDD.
Secondary outcome: Changes in brain activityChanges in menopause-related symptoms among females
Detailed description:
Major Depressive Disorder (MDD) has been associated with morphological changes in the brain
and changes in key brain areas. Studies have shown that antidepressant use may promote the
normalization of these areas. Moreover, midlife men and women appear to be at greater risk
for developing major depressive episodes. In women, this period of 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.
Desvenlafaxine succinate (DVS) has been developed for the treatment of MDD. To date, the
effects of DVS on brain structure and functioning in midlife men and women with MDD, as well
as on depression related to menopause, has not been explored. The present study aims to
investigate the effects of DVS on brain structure and functioning when used for the
treatment of a major depressive episode in midlife men and women, using MRI and functional
MRI. In addition, the investigators will examine whether the impact of treatment with DVS on
vasomotor symptoms, cognition, and quality of life modulate the putative changes in brain
structure and functioning.
Eligibility
Minimum age: 40 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- men and women, aged 40-60 years
- diagnosis of MDD
- for women, perimenopausal or postmenopausal
Exclusion Criteria:
- other DSM-IV axis I diagnosis other than MDD
- using psychotropic medications
- suicidal ideation, homicidal ideation, or psychotic symptoms
- presence of laboratory abnormalities at baseline visit
- presence of heart disease, liver disease, kidney disease, pulmonary disease, blood or
bleeding disease, thyroid disease, GI disease, seizure or epilepsy, head injury,
cancer, uterine fibroids or endometriosis, gynecologic surgeries (except caesarian
sections), electroconvulsive therapies in the past 3 months, HIV+/AIDS
- in addition (for women): use of hormone replacement therapies, menstrual dysfunction,
pregnancy or breastfeeding
Locations and Contacts
Stefanie M Attard, Phone: 905-522-1155, Ext: 32048, Email: sattard@stjoes.ca
Women's Health Concerns Clinic, Hamilton, Ontario L8P 3B6, Canada; Recruiting Stefanie M Attard, Phone: 905-522-1155, Ext: 32048, Email: sattard@stjoes.ca Claudio N Soares, MD, PhD, Principal Investigator Benicio N Frey, MD, PhD, Sub-Investigator Geoff Hall, PhD, Sub-Investigator Meir Steiner, MD, PhD, Sub-Investigator
Additional Information
Starting date: June 2009
Last updated: February 7, 2012
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