Effect of Antidepressants on White Matter Structure
Recruitment status was Recruiting
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.
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||White Matter Structure and Response to Treatment With Antidepressants: a Study of Desvenlafaxine in Major Depression. A Pilot Study|
- Anisotropy [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Degree of anisotropy will be measured at baseline and 16 weeks and correlated to remission status
- cognitive measures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Pain threshold will be measured at basline and 16 weeks and correlated to inflammatory markers and anisotropy
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492621
|Contact: souad Lahlafi, BNurs||5142514000 ext email@example.com|
|Contact: Louise Normandeau, Nurs||5142514000 ext firstname.lastname@example.org|
|Centre de Recherche Fernand-Seguin||Recruiting|
|Montreal, Quebec, Canada, H1N3V2|
|Contact: Souad Lahlafi, Bnurs 5142514000 ext 3416 email@example.com|
|Contact: Louise Normandeau, Nurs 5142514000 ext 3535 firstname.lastname@example.org|
|Principal Investigator:||Smadar V Tourjman, MDCM||University of Montreal, Centre de recherche Fernand Seguin|