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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Duloxetine for Major Depression in Peri-/Postmenopausal Women

NCT00889369

Major Depressive Disorder

UNKNOWN PHASE4

Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women

NCT00683800

Vasomotor Symptoms

COMPLETED PHASE3

Effect of Antidepressants on White Matter Structure

NCT01492621

Major Depression

UNKNOWN PHASE4

Study of Desvenlafaxine in Treating Major Depressive Disorder.

NCT04364997

Major Depressive Disorder

COMPLETED PHASE3

Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women

NCT00406640

Depression Depressive Disorder Depressive Disorder, Major

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Use of desvenlafaxine succinate, flexible dose (50-100mg/day)

Group Type EXPERIMENTAL

Desvenlafaxine Succinate

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Desvenlafaxine Succinate

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pristiq

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes