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

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ClinicalTrials.gov Identifier: NCT00888862
Recruitment Status : Unknown
Verified April 2009 by McMaster University ( Hamilton Health Sciences Corporation ).
Recruitment status was:  Recruiting
First Posted : April 28, 2009
Last Update Posted : February 8, 2012
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 )

Study Description
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Brief 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.

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2009
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Effects of desvenlafaxine succinate (DVS) on brain structure and activation in midlife men and women with MDD. [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Changes in brain activity [ Time Frame: 10 weeks ]
  2. Changes in menopause-related symptoms among females [ Time Frame: 10 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888862


Contacts
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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
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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
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Principal Investigator: Claudio N Soares, MD, PhD St. Joseph's Healtcare; McMaster University
More Information
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Publications of Results:

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Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT00888862    
Other Study ID Numbers: WHCC2008-3
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: April 2009
Keywords provided by McMaster University ( Hamilton Health Sciences Corporation ):
depression
desvenlafaxine
menopause
imaging
FMRI
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs