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The Wellness Monitoring for Major Depressive Disorder (MDD) study is a prospective, longitudinal, observational study aimed at identifying biomarkers of relapse in MDD. Results may help refine clinical approach to relapse management, and may ultimately help MDD patients sustain wellness while on antidepressant medication.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDD | Major Depressive Disorder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of MDD Patients with Near Term Relapse | Relapse is defined as:
| Baseline up to the one year enrolment period for the last-subject-in. |
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Inclusion Criteria:
Exclusion Criteria:
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Men and women between 18 to 65 years of age who have previously met DSM-V criteria for Major Depressive Episode (MDE) in MDD as determined by MINI, (1) who participated in CAN-BIND-1 protocol, (2) other CAN-BIND studies, and (3) other remitters who meet the inclusion criteria who are currently responding to antidepressant medication or a combination of treatments.
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| Name | Affiliation | Role |
|---|---|---|
| Sidney H. Kennedy, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada | ||
| University of British Columbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22681173 | Background | Kennedy SH, Downar J, Evans KR, Feilotter H, Lam RW, MacQueen GM, Milev R, Parikh SV, Rotzinger S, Soares C. The Canadian Biomarker Integration Network in Depression (CAN-BIND): advances in response prediction. Curr Pharm Des. 2012;18(36):5976-89. doi: 10.2174/138161212803523635. | |
| 27084692 | Background | Lam RW, Milev R, Rotzinger S, Andreazza AC, Blier P, Brenner C, Daskalakis ZJ, Dharsee M, Downar J, Evans KR, Farzan F, Foster JA, Frey BN, Geraci J, Giacobbe P, Feilotter HE, Hall GB, Harkness KL, Hassel S, Ismail Z, Leri F, Liotti M, MacQueen GM, McAndrews MP, Minuzzi L, Muller DJ, Parikh SV, Placenza FM, Quilty LC, Ravindran AV, Salomons TV, Soares CN, Strother SC, Turecki G, Vaccarino AL, Vila-Rodriguez F, Kennedy SH; CAN-BIND Investigator Team. Discovering biomarkers for antidepressant response: protocol from the Canadian biomarker integration network in depression (CAN-BIND) and clinical characteristics of the first patient cohort. BMC Psychiatry. 2016 Apr 16;16:105. doi: 10.1186/s12888-016-0785-x. |
| Label | URL |
|---|---|
| Press release | View source |
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This study is funded in part by the Ontario Brain Institute (OBI). Data collected from this study is entered into a research database called "Brain-CODE", deployed at a High Performance Computer Virtual Lab (HPCVL). The HPCVL supports the regulatory-compliant (e.g., 21 CRF Part 11, HIPAA, PIPEDA) processes for securing privacy of healthcare data.
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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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.
| Vancouver |
| British Columbia |
| V6T 1Z3 |
| Canada |
| McMaster University | Hamilton | Ontario | L8N 3K7 | Canada |
| Queen's University | Kingston | Ontario | K7L 4X3 | Canada |
| University Health Network | Toronto | Ontario | M5T 2S8 | Canada |
| 27974997 | Background | Vaccarino AL, Evans KR, Kalali AH, Kennedy SH, Engelhardt N, Frey BN, Greist JH, Kobak KA, Lam RW, MacQueen G, Milev R, Placenza FM, Ravindran AV, Sheehan DV, Sills T, Williams JB. The Depression Inventory Development Workgroup: A Collaborative, Empirically Driven Initiative to Develop a New Assessment Tool for Major Depressive Disorder. Innov Clin Neurosci. 2016 Oct 1;13(9-10):20-31. eCollection 2016 Sep-Oct. |
| CAN-BIND study website | View source |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |