Clinical trial NCT00888862: Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women
Official title: Desvenlafaxine Succinate in Major Depressive Disorder: Effects on Structural and Functional Imaging, Cognition, and Functional Outcomes in Midlife Women and Men
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Major Depressive Disorder
Menopausal Staging and Vasomotor Symptoms (for Females)
Keywords: depression
desvenlafaxine
menopause
imaging
FMRI
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
name: St. Joseph's Healthcare Hamilton
name: McMaster University
First posted: 2009-04-28
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Effects of desvenlafaxine succinate (DVS) on brain structure and activation in midlife men and women with MDD.
timeFrame: 10 weeks
Secondary outcomes:
measure: Changes in brain activity
timeFrame: 10 weeks
measure: Changes in menopause-related symptoms among females
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Women's Health Concerns Clinic
state: Ontario
Study officials:
affiliation: St. Joseph's Healtcare; McMaster University
name: Claudio N Soares, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.