Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women
NCT00888862
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- men and women, aged 40-60 years
- diagnosis of MDD
- for women, perimenopausal or postmenopausal
- 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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Descriptive Information | ||||
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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 |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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Investigators ICMJE |
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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 |