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

• Status: Unknown status
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborators: McMaster University; St. Joseph's Healthcare Hamilton; Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Desvenlafaxine Succinate

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