Bipolar and Related Disorders, Depressive Disorder, Mood Disorders
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
St. Joseph's Healthcare Hamilton
Unity Health Toronto
Centre for Addiction and Mental Health
Queen's University
University of Ottawa
University of British Columbia
University of Calgary
McGill University
Nova Scotia Health Authority
University of Michigan
Simon Fraser University
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients: 1. 16 years of age or older. 2. Meet criteria for bipolar or depressive disorders as defined by DSM-5. 3. Fluency in English, sufficient to complete the interviews and self-report questionnaires. Inclusion Criteria Healthy Comparison (HC) Participants: 1. 16 years of age or older. 2. No history of psychiatric disorders (according to DSM-5) or significant unstable medical conditions. 3. Fluency in English, sufficient to complete the interviews and self-report questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of participation in the master trial platform | 31st March 2026 | Number of participants who consent to be included in the registry |
Countries
Canada
Contacts
CONTACTSaba Khoshroo
PRINCIPAL_INVESTIGATORBenicio N Frey
St. Joseph's Healthcare Hamilton
Outcome results
None listed