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

Major Depressive Disorder Clinical Trial

— DVS  

Official title:

Desvenlafaxine Succinate in Major Depressive Disorder: Effects on Structural and Functional Imaging, Cognition, and Functional Outcomes in Midlife Women and Men

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00888862
• Other study ID #: WHCC2008-3
• Status: Recruiting
• Phase: Phase 3
• First received: April 27, 2009
• Last updated: February 7, 2012
• Start date: June 2009
• Est. completion date: October 2012

Study information

• Verified date: April 2009
• Source: McMaster University
• Contact: Stefanie M Attard
• Phone: 905-522-1155
• Email: sattard[@]stjoes.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Menopausal Staging and Vasomotor Symptoms (for Females)

Intervention

Drug:
• Desvenlafaxine Succinate
Desvenlafaxine Succinate, 50-100mg/day for 8 weeks

Locations

Country	Name	City	State
Canada	Women's Health Concerns Clinic	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	McMaster University, St. Joseph's Healthcare Hamilton, Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of desvenlafaxine succinate (DVS) on brain structure and activation in midlife men and women with MDD.		10 weeks	No
Secondary	Changes in brain activity		10 weeks	No
Secondary	Changes in menopause-related symptoms among females		10 weeks	No