NCT00888862

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3 major-depressive-disorder

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_3 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 8, 2012

Status Verified

April 1, 2009

Enrollment Period

3 years

First QC Date

April 27, 2009

Last Update Submit

February 7, 2012

Conditions

Major Depressive DisorderMenopausal Staging and Vasomotor Symptoms (for Females)

Keywords

depressiondesvenlafaxinemenopauseimagingFMRI

Outcome Measures

Primary Outcomes (1)

  • Effects of desvenlafaxine succinate (DVS) on brain structure and activation in midlife men and women with MDD.

    10 weeks

Secondary Outcomes (2)

  • Changes in brain activity

    10 weeks

  • Changes in menopause-related symptoms among females

    10 weeks

Study Arms (1)

A

EXPERIMENTAL

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

Drug: Desvenlafaxine Succinate

Interventions

Desvenlafaxine SuccinateDRUG

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

Also known as: Pristiq
A

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • men and women, aged 40-60 years
  • diagnosis of MDD
  • for women, perimenopausal or postmenopausal

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Health Concerns Clinic

Hamilton, Ontario, L8P 3B6, Canada

RECRUITING

Related Publications (1)

  • Frey BN, Hall GB, Attard S, Yucel K, Skelin I, Steiner M, Soares CN. Shift in the brain network of emotional regulation in midlife women: is the menopausal transition the turning point? Menopause. 2010 Jul;17(4):840-5. doi: 10.1097/gme.0b013e3181df840f.

    PMID: 20616670RESULT

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticLipids

Study Officials

  • Claudio N Soares, MD, PhD

    St. Joseph's Healtcare; McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanie M Attard

CONTACT

905-522-1155sattard@stjoes.ca

Benicio N Frey, MD, PhD

CONTACT

905-522-1155freybn@mcmaster.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 28, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2012

Study Completion

October 1, 2012

Last Updated

February 8, 2012

Record last verified: 2009-04

Locations

CA(1)