An Innovative Master Platform for Clinical Trials in Mood Disorders (ENABLE)

January 20, 2026 updated by: Benicio Frey, St. Joseph's Healthcare Hamilton

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.

Study Overview

Status

Recruiting

Conditions

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 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.

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Recruiting
        • University of Calgary
        • Principal Investigator:
          • Valerie H Taylor, MD, PhD
        • Contact:
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2A1
        • Recruiting
        • University of British Columbia
        • Principal Investigator:
          • Raymond W Lam, MD
        • Contact:
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2E2
        • Recruiting
        • Nova Scotia Health Authority
        • Principal Investigator:
          • Rudolf Uher, MD
        • Contact:
    • Ontario
      • Hamilton, Ontario, Canada, L8P 3B6
        • Recruiting
        • McMaster University
        • Principal Investigator:
          • Benicio N Frey, MD, PhD
        • Contact:
      • Kingston, Ontario, Canada, K7L4X3
        • Recruiting
        • Queen's University
        • Principal Investigator:
          • Roumen Milev, MD, PhD
        • Contact:
      • Ottawa, Ontario, Canada, K1Z 7K4
        • Recruiting
        • University of Ottawa
        • Principal Investigator:
          • Pierre Blier, MD, PhD
        • Contact:
      • Toronto, Ontario, Canada, M6J 1H4
        • Recruiting
        • Centre for Addiction and Mental Health
        • Contact:
        • Principal Investigator:
          • Lena Quilty, PhD
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • University Health Network
        • Contact:
        • Principal Investigator:
          • Joshua Rosenblat, MD
      • Whitby, Ontario, Canada, L1N 5S9
        • Recruiting
        • Ontario Shores Centre for Mental Health Sciences
        • Contact:
        • Principal Investigator:
          • Daniel Müeller, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Individuals who meet criteria for bipolar or depressive disorders as defined by DSM-5.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participation in the master trial platform
Time Frame: 31st March 2026
Number of participants who consent to be included in the registry
31st March 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

University Health Network, Toronto
University of British Columbia
McGill University
Centre for Addiction and Mental Health
University of Michigan
Unity Health Toronto
University of Calgary
University of Ottawa
Queen's University
Nova Scotia Health Authority
Simon Fraser University

Investigators

  • Principal Investigator: Benicio N Frey, St. Joseph's Healthcare Hamilton

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2023

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAN-BIND-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Currently till the end of March, 2026.

IPD Sharing Access Criteria

By application.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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