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

NCT00888862

Last updated date
Study Location
Women's Health Concerns Clinic
Hamilton, Ontario, L8P 3B6, Canada
Contact
905-522-1155

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder, Menopausal Staging and Vasomotor Symptoms (for Females)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- men and women, aged 40-60 years

- diagnosis of MDD

- for women, perimenopausal or postmenopausal

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Major Depressive Disorder, Menopausal Staging and Vasomotor Symptoms (for Females)Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women
NCT00888862
  1. Hamilton, Ontario
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women
Official Title  ICMJE Desvenlafaxine Succinate in Major Depressive Disorder: Effects on Structural and Functional Imaging, Cognition, and Functional Outcomes in Midlife Women and Men
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Menopausal Staging and Vasomotor Symptoms (for Females)
Intervention  ICMJE Drug: Desvenlafaxine Succinate
Desvenlafaxine Succinate, 50-100mg/day for 8 weeks
Other Name: Pristiq
Study Arms  ICMJE Experimental: A
Use of desvenlafaxine succinate, flexible dose (50-100mg/day)
Intervention: Drug: Desvenlafaxine Succinate
Publications * Frey BN, Hall GB, Attard S, Yucel K, Skelin I, Steiner M, Soares CN. Shift in the brain network of emotional regulation in midlife women: is the menopausal transition the turning point? Menopause. 2010 Jul;17(4):840-5. doi: 10.1097/gme.0b013e3181df840f.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 27, 2009)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2012
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00888862
Other Study ID Numbers  ICMJE WHCC2008-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party McMaster University ( Hamilton Health Sciences Corporation )
Study Sponsor  ICMJE Hamilton Health Sciences Corporation
Collaborators  ICMJE
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • St. Joseph's Healthcare Hamilton
  • McMaster University
Investigators  ICMJE
Principal Investigator:Claudio N Soares, MD, PhDSt. Joseph's Healtcare; McMaster University
PRS Account McMaster University
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP