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

Phase 3

• Conditions: Major Depressive Disorder; Menopausal Staging and Vasomotor Symptoms (for Females)
• Interventions: Drug: Desvenlafaxine Succinate

• Registration Number: NCT00888862
• Lead Sponsor: Hamilton Health Sciences Corporation

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 Timeline

• Status Verified: 2009-04
• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-27
• Study First Posted: 2009-04-28
• Study Start: 2009-06
• Last Update Submitted: 2012-02-07
• Last Update Posted: 2012-02-08
• Primary Completion: 2012-06
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Desvenlafaxine Succinate	Use of desvenlafaxine succinate, flexible dose (50-100mg/day)

Primary Outcome Measures

Name	Time	Method
Effects of desvenlafaxine succinate (DVS) on brain structure and activation in midlife men and women with MDD.	10 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in brain activity	10 weeks
Changes in menopause-related symptoms among females	10 weeks

Trial Locations

Locations (1)

Women's Health Concerns Clinic; 🇨🇦 Hamilton, Ontario, Canada