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| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
| Centre for Addiction and Mental Health | OTHER |
| Queen's University | OTHER |
| University of Ottawa |
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Mood disorders such as depression and bipolar disorder affect over 350 million people around the world. While several effective treatments exist, it is often difficult to match the right treatment to an individual person. Repeated efforts to find the right treatment contribute to poor functioning, low quality of life, and prolongs the time it takes to get well. Most areas of medicine are able to use 'biomarkers' or clinical tests, blood tests, or imaging to help diagnose and treat illness. The search for biomarkers in mood disorders is advancing, but one roadblock to progress is the lack of large, standardized studies of mood disorders that are needed to accurately identify biomarkers. The aim of the ENABLE platform is to provide the Canadian neuroscience community a standardized way of collecting biomarker data from individuals with a range of mood disorders symptoms. In addition, this 'master clinical trial platform' framework will provide a pool of participants who can be recruited into biomarker-based clinical trials.
The ENABLE platform offers to the Canadian neuroscience community (1) standardized data collection methods with deep clinical and neurobiological phenotyping of individuals across the spectrum of mood disorder symptoms; (2) a recruitment pool for efficient launch of clinical trials; and (3) an open source of clinical and neurobiological data for discovery analyses and/or grant applications.
The assessments have been categorized into a tiered system, where participants must consent to complete tier 1 items in order to be enrolled in the platform. Tier 2 items will be optional measures, the absence of these measures will not compromise the inclusion in the platform. A separate written informed consent to be contacted regarding participation in future clinical trials associate with the ENABLE platform will also be offered.
At tier 1, individuals complete clinical assessments (clinician administered and self-report) and during their tier 2, they provide blood, undergo neuroimaging procedures (MRI and EEG); and are given an actigraphy device to wear for two weeks.
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of participation in the master trial platform | Number of participants who consent to be included in the registry | 31st March 2026 |
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Inclusion Criteria
Patients:
Inclusion Criteria
Healthy Comparison (HC) Participants:
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Individuals who meet criteria for bipolar or depressive disorders as defined by DSM-5.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saba Khoshroo | Contact | 905-522-1155 | 36462 | skhoshro@stjoes.ca |
| Name | Affiliation | Role |
|---|---|---|
| Benicio N Frey | St. Joseph's Healthcare Hamilton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Recruiting | Calgary | Alberta | T2N 4Z6 | Canada |
This study is funded by the Ontario Brain Institute (OBI) and Brain Canada. Data collected from this study is entered into a research database called "Brain-CODE",(https://www.braincode.ca/content/about-brain-code), which is currently hosted on high performance computing nodes at the Centre for Advanced Computing (CAC) (https://cac.queensu.ca/) at Queen's University in Ontario, Canada. Participant data will be available to the neuroscience community. Through Brain-CODE, data can be available by submitting a secure form which will need to be done across all platform sites in order to access the data. The IPD that will be shared could include clinical assessments (clinician administered and self-report), neuroimaging (EEG and MRI), and actigraphy data.
Currently till the end of March, 2026.
By application.
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| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D003866 | Depressive Disorder |
| D000068105 | Bipolar and Related Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| OTHER |
| University of British Columbia | OTHER |
| University of Calgary | OTHER |
| McGill University | OTHER |
| Nova Scotia Health Authority | OTHER |
| University of Michigan | OTHER |
| Simon Fraser University | OTHER |
| University Health Network, Toronto | OTHER |
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Blood Plasma: Venous blood will be collected in blood collection tubes, followed by centrifugation in a refrigerated centrifuge to obtain the plasma. The entire plasma sample from each tube will be equally divided into labelled cryovials (each minimum 1 mL) and stored at -80oC at the clinical site.
Peripheral Blood Mononuclear Cells (PBMCs): Venous blood will be collected in blood collection tubes, followed by centrifugation and processing to obtain PBMCs that will be divided in 1 ml labeled aliquots and stored at -80oC at the clinical site.
Whole blood for RNA analysis: Venous blood will be collected in blood collection tubes, processed following the most updated SOP, labeled, and stored at -80oC at each clinical site.
| University of British Columbia | Recruiting | Vancouver | British Columbia | V6T 2A1 | Canada |
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| Nova Scotia Health Authority | Recruiting | Halifax | Nova Scotia | B3H 2E2 | Canada |
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| McMaster University | Recruiting | Hamilton | Ontario | L8P 3B6 | Canada |
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| Queen's University | Recruiting | Kingston | Ontario | K7L4X3 | Canada |
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| University of Ottawa | Recruiting | Ottawa | Ontario | K1Z 7K4 | Canada |
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| University Health Network | Recruiting | Toronto | Ontario | M5T 2S8 | Canada |
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| Centre for Addiction and Mental Health | Recruiting | Toronto | Ontario | M6J 1H4 | Canada |
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| Ontario Shores Centre for Mental Health Sciences | Recruiting | Whitby | Ontario | L1N 5S9 | Canada |
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