Effect of Antidepressants on White Matter Structure

Phase 4

• Conditions: Major Depression

• Registration Number: NCT01492621
• Lead Sponsor: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

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.

Study Timeline

• Study Start: 2011-11
• Status Verified: 2011-12
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-14
• Last Update Submitted: 2011-12-14
• Study First Posted: 2011-12-15
• Last Update Posted: 2011-12-15
• Primary Completion: 2013-09
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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) -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Anisotropy	16 weeks	Degree of anisotropy will be measured at baseline and 16 weeks and correlated to remission status

Secondary Outcome Measures

Name	Time	Method
cognitive measures	16 weeks	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	16 weeks	Pain threshold will be measured at basline and 16 weeks and correlated to inflammatory markers and anisotropy

Trial Locations

Locations (1)

Centre de Recherche Fernand-Seguin; 🇨🇦 Montreal, Quebec, Canada