Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by McMaster University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Wyeth is now a wholly owned subsidiary of Pfizer
St. Joseph's Healthcare Hamilton
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier:
NCT00888862
First received: April 27, 2009
Last updated: February 7, 2012
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Menopausal Staging and Vasomotor Symptoms (for Females)
Drug: Desvenlafaxine Succinate
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Desvenlafaxine Succinate in Major Depressive Disorder: Effects on Structural and Functional Imaging, Cognition, and Functional Outcomes in Midlife Women and Men

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Effects of desvenlafaxine succinate (DVS) on brain structure and activation in midlife men and women with MDD. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in brain activity [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Changes in menopause-related symptoms among females [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2009
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Use of desvenlafaxine succinate, flexible dose (50-100mg/day)
Drug: Desvenlafaxine Succinate
Desvenlafaxine Succinate, 50-100mg/day for 8 weeks
Other Name: Pristiq

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

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888862

Contacts
Contact: Stefanie M Attard 905-522-1155 ext 32048 sattard@stjoes.ca
Contact: Benicio N Frey, MD, PhD 905-522-1155 ext 35123 freybn@mcmaster.ca

Locations
Canada, Ontario
Women's Health Concerns Clinic Recruiting
Hamilton, Ontario, Canada, L8P 3B6
Contact: Stefanie M Attard    905-522-1155 ext 32048    sattard@stjoes.ca   
Principal Investigator: Claudio N Soares, MD, PhD         
Sub-Investigator: Benicio N Frey, MD, PhD         
Sub-Investigator: Geoff Hall, PhD         
Sub-Investigator: Meir Steiner, MD, PhD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Wyeth is now a wholly owned subsidiary of Pfizer
St. Joseph's Healthcare Hamilton
McMaster University
Investigators
Principal Investigator: Claudio N Soares, MD, PhD St. Joseph's Healtcare; McMaster University
  More Information

Publications:
Responsible Party: McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier: NCT00888862     History of Changes
Other Study ID Numbers: WHCC2008-3
Study First Received: April 27, 2009
Last Updated: February 7, 2012
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
depression
desvenlafaxine
menopause
imaging
FMRI

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
O-desmethylvenlafaxine
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014