Mood DisordersENABLENCT06408012
An Innovative Master Platform for Clinical Trials in Mood Disorders
An observational study of Mood Disorders and Depressive Disorder, run by St. Joseph's Healthcare Hamilton at 9 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mood Disorders, Depressive Disorder, Bipolar and Related Disorders
- How many people
- 2,200 participants
- Where
- 9 sitesCanada
- Study dates
- 17 Oct 2023to 31 Mar 2029
- How long will I take part?
- 1 Day
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals who meet criteria for bipolar or depressive disorders as defined by DSM-5.
Who may be able to join
- Patients:
- 16 years of age or older.
- Meet criteria for bipolar or depressive disorders as defined by DSM-5.
- Fluency in English, sufficient to complete the interviews and self-report questionnaires.
- Healthy Comparison (HC) Participants:
- 16 years of age or older.
- No history of psychiatric disorders (according to DSM-5) or significant unstable medical conditions.
- Fluency in English, sufficient to complete the interviews and self-report questionnaires.
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Canada9 sites, 9 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 4Z6
Alexandra Du, 403-220-6533, mi.du@ucalgary.ca
Valerie H Taylor, MD, PhD
- Recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2E2
Mayank Ramchandani, 902-473-1782, Mayank.Ramchandani@nshealth.ca
Rudolf Uher, MD
- Recruiting
McMaster University
Hamilton, Ontario, L8P 3B6
Saba Khoshroo, MSc, 905 522 1155 ext. 36462, skhoshro@stjoes.ca
Benicio N Frey, MD, PhD
- Recruiting
Queen's University
Kingston, Ontario, K7L4X3
Rida Khan, 613-544-4900 ext. 53354, khanr@providencecare.ca
Roumen Milev, MD, PhD
- Recruiting
University of Ottawa
Ottawa, Ontario, K1Z 7K4
Yamini Singh, 613.722.6521 ext. 6405, yamini.singh@theroyal.ca
Pierre Blier, MD, PhD
- Recruiting
University Health Network
Toronto, Ontario, M5T 2S8
Marianne Bautista, (416) 603-5800 ext. 6311, Marianne.Bautista@uhn.ca
Joshua Rosenblat, MD
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
Aidan Schottler-Raymond, Aidan.Schottler-Raymond@camh.ca
Lena Quilty, PhD
- Recruiting
University of British Columbia
Vancouver, British Columbia, V6T 2A1
Orli Hellerstein, 604 822 0332, orli.hellerstein@ubc.ca
Raymond W Lam, MD
- Recruiting
Ontario Shores Centre for Mental Health Sciences
Whitby, Ontario, L1N 5S9
Houra Parsinejad, 905.430.4055 ext. 6134, parsinejadh@ontarioshores.ca
Daniel Mueller, MD, PhD
About this study
Official title: Enabling Neuroscience Research Approaches for Brain, feeLings and Emotions (ENABLE): An Innovative Platform for Clinical Trials in Mood Disorders
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.
Read the 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.
- Medical subject headings
- Mood Disorders, Depressive Disorder, Bipolar and Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participation in the master trial platform
Number of participants who consent to be included in the registry
Measured: 31st March 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start17 Oct 2023
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Benicio Frey, St. Joseph's Healthcare Hamilton
- Investigators
- Benicio N Frey, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408012
- Sponsor's protocol ID
- CAN-BIND-18
- Acronym
- ENABLE
- Status last verified
- Jul 2026
- First submitted
- 6 May 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.