Back to resultsEffect of Antidepressants on White Matter Structure
Primary Purpose
Major Depression
Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Desvenlafaxine
Sponsored by
About this trial
This is an interventional basic science trial for Major Depression focused on measuring major depression, DTI, inflammatory markers, cognition
Eligibility Criteria
Inclusion Criteria:
- Major depression
- Age 18 to 55
- Hamilton grater or equal to 20
Exclusion Criteria:
- 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) -
Sites / Locations
- Centre de Recherche Fernand-SeguinRecruiting
Outcomes
Primary Outcome Measures
Anisotropy
Degree of anisotropy will be measured at baseline and 16 weeks and correlated to remission status
Secondary Outcome Measures
cognitive measures
cognitive deficits will be measured at baseline and 16 weeks and correlated to anisotropy using computerized neuropsychological testing of memory, speed and executive function.
Pain threshold
Pain threshold will be measured at basline and 16 weeks and correlated to inflammatory markers and anisotropy
Full Information
NCT ID
NCT01492621
First Posted
December 12, 2011
Last Updated
December 14, 2011
Sponsor
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01492621
Brief Title
Effect of Antidepressants on White Matter Structure
Official Title
White Matter Structure and Response to Treatment With Antidepressants: a Study of Desvenlafaxine in Major Depression. A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
40 subjects will be included in the study. Diagnosis will be confirmed by MINI. Participants will be characterised using questionnaires, pain threshold, cognition, facial expression recording and MRI. Desvenlafaxine will be initiated at 50mg AM. At week 8 Desvenlafaxine may be increased to 100mg as clinically indicated. Measures will be repeated at the end of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
major depression, DTI, inflammatory markers, cognition
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine
Other Intervention Name(s)
Pristiq
Intervention Description
Desvenlafaxine 50mg from week 1-8. At week 8 optional increase to 100mg if remission has not been attained.
Primary Outcome Measure Information:
Title
Anisotropy
Description
Degree of anisotropy will be measured at baseline and 16 weeks and correlated to remission status
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
cognitive measures
Description
cognitive deficits will be measured at baseline and 16 weeks and correlated to anisotropy using computerized neuropsychological testing of memory, speed and executive function.
Time Frame
16 weeks
Title
Pain threshold
Description
Pain threshold will be measured at basline and 16 weeks and correlated to inflammatory markers and anisotropy
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major depression
Age 18 to 55
Hamilton grater or equal to 20
Exclusion Criteria:
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) -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
souad Lahlafi, BNurs
Phone
5142514000
Ext
3416
Email
slahlafi.crfs@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Louise Normandeau, Nurs
Phone
5142514000
Ext
3535
Email
lnormandeau.hlhl@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Smadar V Tourjman, MDCM
Organizational Affiliation
University of Montreal, Centre de recherche Fernand Seguin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche Fernand-Seguin
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1N3V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Souad Lahlafi, Bnurs
Phone
5142514000
Ext
3416
Email
slahlafi.crfs@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Louise Normandeau, Nurs
Phone
5142514000
Ext
3535
Email
lnormandeau.hlhl@ssss.gouv.qc.ca
12. IPD Sharing Statement
Learn more about this trial
Effect of Antidepressants on White Matter Structure
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