Effect of Antidepressants on White Matter Structure
White Matter Structure and Response to Treatment With Antidepressants: a Study of Desvenlafaxine in Major Depression. A Pilot Study
1 other identifier
interventional
40
1 country
1
Brief Summary
Subjects with major depression will be evaluated and intensively characterized through questionnaires, computerized cognitive evaluation and laboratory investigations. Magnetic resonance imaging will be used to document baseline white matter structure. subjects will then receive desvenlafaxine which will be adjusted as clinically indicated. After 16 weeks the evaluations will be repeated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 12, 2011
CompletedFirst Posted
Study publicly available on registry
December 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedDecember 15, 2011
December 1, 2011
1.8 years
December 12, 2011
December 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anisotropy
Degree of anisotropy will be measured at baseline and 16 weeks and correlated to remission status
16 weeks
Secondary Outcomes (2)
cognitive measures
16 weeks
Pain threshold
16 weeks
Interventions
Desvenlafaxine 50mg from week 1-8. At week 8 optional increase to 100mg if remission has not been attained.
Eligibility Criteria
You may qualify if:
- Major depression
- Age 18 to 55
- Hamilton grater or equal to 20
You may not qualify if:
- Major neurologic disorder
- Major cardiovascular disorder
- Unstable medical condition
- Significant psychiatric co-morbidity
- Current substance dependance
- Pregnancy or lactation -Treatment resistance as defined by nonresponse to 2 or more antidepressant treatments (adequate dose and duration) -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de Recherche Fernand-Seguin
Montreal, Quebec, H1N3V2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Smadar V Tourjman, MDCM
University of Montreal, Centre de recherche Fernand Seguin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate director of clinical research
Study Record Dates
First Submitted
December 12, 2011
First Posted
December 15, 2011
Study Start
November 1, 2011
Primary Completion
September 1, 2013
Study Completion
November 1, 2013
Last Updated
December 15, 2011
Record last verified: 2011-12