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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Joseph's Healthcare Hamilton

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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