Recruiting
Phase 3

Desvenlafaxine

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT00888862

Conditions

Major Depressive Disorder

Menopausal Staging and Vasomotor Symptoms (for Females)

Eligibility Criteria

Sex: All

Age: 40 - 60

Healthy Volunteers: Accepted

Interventions

Desvenlafaxine Succinate

Study Details

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.

Conditions

Major Depressive Disorder

Menopausal Staging and Vasomotor Symptoms (for Females)

Study ID

NCT00888862

Start date

Jun, 2009

Status verified date

Apr, 2009

Completion date

Oct, 2012

Anticipated

Primary completion date

Jun, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 60

Healthy Volunteers: 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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A

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

Interventions

Desvenlafaxine Succinate

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

Primary outcome measure

  • Effects of desvenlafaxine succinate (DVS) on brain structure and activation in midlife men and women with MDD. [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Stefanie M Attard

905-522-1155sattard@stjoes.ca

Benicio N Frey, MD, PhD

905-522-1155freybn@mcmaster.ca

Locations

Women's Health Concerns Clinic

Recruiting

Hamilton, Ontario, Canada, L8P 3B6

Contacts

Stefanie M Attard

905-522-1155sattard@stjoes.ca

Principal Investigator:

Claudio N Soares, MD, PhD

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Feb 8, 2012

Last verified

Apr, 2009

Keywords

  • depression
  • desvenlafaxine
  • menopause
  • imaging
  • FMRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2012-02-08.