Wellness Monitoring for Major Depressive Disorder (CBN-Well)
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|ClinicalTrials.gov Identifier: NCT02934334|
Recruitment Status : Completed
First Posted : October 14, 2016
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment|
|Major Depressive Disorder||Other: Observational|
This study involves a naturalistic follow up of responders from the study entitled "Integrated biological markers for the prediction of treatment response in depression", or the CAN-BIND-1 study. In addition, this study is also open to other participants who completed other CAN-BIND studies, as well as remitters who meet the inclusion criteria. Since patients usually seek medical attention only after relapse has occurred, imminent precursors to relapse are not well known. In this study, participants who are currently responding to an oral antidepressant treatment regimen and/or therapeutic intervention will be monitored over a minimum period of 13 months, which provides a unique opportunity to discover near-term biomarkers of relapse.
The study is conducted in partnership with Janssen Research & Development and utilizes remote monitoring technology for data gathering.
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||A Collaborative Investigation of Predictors of Relapse in Major Depressive Disorder: CAN-BIND-1 Extension Study|
|Actual Study Start Date :||May 31, 2016|
|Actual Primary Completion Date :||January 14, 2019|
|Actual Study Completion Date :||February 25, 2019|
Major Depressive Disorder
- Rate of MDD Patients with Near Term Relapse [ Time Frame: Baseline up to the one year enrolment period for the last-subject-in. ]
Relapse is defined as:
- MADRS total score equal to or greater than 22 on at least 2 consecutive visits (scheduled or unscheduled);
- Hospitalization for worsening of depression;
- Suicidal ideation with intent, or suicidal behaviour;
- Others. Investigators will be asked to describe.
Biospecimen Retention: Samples With DNA
At each 8 week visit, blood samples for biochemical, genomic, and proteomic analysis will be collected and stored at -80'C freezer.
Plasma: Venous blood will be collected in 6mL and 10ml EDTA blood tubes, followed by centrifugation in a refrigerated centrifuge to obtain the plasma. Two milliliters of plasma from each tube will be divided into 8 cryovials (500µL).
DNA for methylation analysis: Venous blood will be collected in 8.5 mL PAXgene DNA tubes.
DNA for studying histone modifications: Venous blood will be collected in 6mL EDTA blood tubes and the mixed contents will be divided evenly into three 2 mL screw-cap tubes.
RNA for mRNA and miRNA sequencing: Venous blood will be collected in 6mL EDTA blood tubes and the mixed contents will be passed through LeukoLOCK filters according to the manufacturer's instructions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934334
|University of Calgary|
|Calgary, Alberta, Canada, T2N 4Z6|
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada, V6T 1Z3|
|Hamilton, Ontario, Canada, L8N 3K7|
|Kingston, Ontario, Canada, K7L 4X3|
|University Health Network|
|Toronto, Ontario, Canada, M5T 2S8|
|Principal Investigator:||Sidney H. Kennedy, MD||University Health Network, Toronto|