Canadian Biomarker Integration Network for Depression (CAN-BIND) - Validation Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Major Depressive Disorder
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: Non-RandomizedIntervention Model: Factorial AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
Description
This is a multi-site study to replicate a previous multi-site, multi-platform study completed by the Canadian Biomarker Integration Network in Depression (CAN-BIND). This study aims to validate the integrated array of markers of response and non-response to first line antidepressant treatments that ...
This is a multi-site study to replicate a previous multi-site, multi-platform study completed by the Canadian Biomarker Integration Network in Depression (CAN-BIND). This study aims to validate the integrated array of markers of response and non-response to first line antidepressant treatments that were previously identified in the original aforementioned study. This will be accomplished through collection of clinical, neurophysiological, and molecular measures. This is not a study to evaluate efficacy of medications; medications in this study have been approved by Health Canada and are widely used for the treatment of MDD. In this study, individuals diagnosed with MDD in a current major depressive episode (MDE) will be treated with open-label escitalopram for 8 weeks. At week 8, participants will be assessed for treatment response (defined as a ?50% reduction in Montgomery Asberg Depression Rating Scale score). Responders will continue on escitalopram for 8 more weeks. Non-responders will be given add-on brexpiprazole treatment, in addition to escitalopram, for 8 weeks. Over the 16 weeks, pariticipants will attend 7 clinical visits where they will complete clinical assessments (clinician administered and self-report) and cognitive tests; provide blood, urine, and stool samples; undergo neuroimaging procedures (MRI and EEG); and provide speech samples. At the end of the study, modeling methods will be used to integrate data from these measures to determine the features that best predict treatment outcome.
Tracking Information
- NCT #
- NCT04162522
- Collaborators
- Baycrest
- Unity Health Toronto
- Centre for Addiction and Mental Health
- McMaster University
- Queen's University
- University of Ottawa
- University of British Columbia
- University of Calgary
- McGill University
- Dalhousie University
- University of Michigan
- Simon Fraser University
- Investigators
- Principal Investigator: Sidney H Kennedy, MD University Health Network, St. Michael's University, University of Toronto