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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 activity

Changes 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

Page last updated: August 23, 2015

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