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

Hamilton Health Sciences (HHS)

Status and phase

Unknown

Phase 3

Conditions

Menopausal Staging and Vasomotor Symptoms (for Females)

Major Depressive Disorder

Treatments

Drug: Desvenlafaxine Succinate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00888862

WHCC2008-3

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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