An observational study in Mood Disorders, Depressive Disorder and Bipolar and Related Disorders, sponsored by St. Joseph's Healthcare Hamilton. Recruiting at 9 sites in Canada. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by St. Joseph's Healthcare Hamilton · Observational
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 question will be included in the informed consent process asking participants whether they agree to be contacted about future clinical trials associated with the ENABLE platform.
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); complete a cognitive task (CNS Vital Signs) and are given an actigraphy device to wear for two weeks.
855 studies on the registry are indexed under Depressive Disorder; 159 are open to participants now.
This study's planned enrollment of 2,200 is above the median of 174 across 140 observational studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →St. Joseph's Healthcare Hamilton is the lead sponsor of 143 studies on the registry; 33 are open to participants now.
Compared within Depressive Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Mood Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Individuals who meet criteria for bipolar or depressive disorders as defined by DSM-5.
Inclusion Criteria
Patients:
Inclusion Criteria
Healthy Comparison (HC) Participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rate of participation in the master trial platform
Number of participants who consent to be included in the registry
Time frame: 31st March 2026
Plan to share: Yes — 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). Access to REDCap and BrainCODE will be secured by an encrypted virtual private network and protected by multiple levels of authentication. A Data Manager will be assigned administrative privileges for study configuration, design of CRFs, data entry management, and quality control. 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.
Supporting information: Study protocol
Time frame: Currently till the end of March, 2029.
Access criteria: By application.
Data sharing details ↗ · braininstitute.ca
No publications or documents are linked to this record.
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