An Innovative Master Platform for Clinical Trials in Mood Disorders

ClinicalTrials.gov ID

NCT06408012

Lead Sponsor

St. Joseph's Healthcare HamiltonOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

2,200Estimated

Last Update Posted

Jul 13, 2026Actual

Start Date

Oct 17, 2023Actual

Primary Completion Date

Mar 31, 2029Estimated

Completion Date

Mar 31, 2029Estimated

Official Title

Enabling Neuroscience Research Approaches for Brain, feeLings and Emotions (ENABLE): An Innovative Platform for Clinical Trials in Mood Disorders

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.

• Mood Disorders
• Depressive Disorder
• Bipolar and Related Disorders

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Cross-Sectional

Lead Sponsor

St. Joseph's Healthcare HamiltonOTHER

Collaborators

Unity Health TorontoOTHER

Centre for Addiction and Mental HealthOTHER

Queen's UniversityOTHER

University of OttawaOTHER

University of British ColumbiaOTHER

University of CalgaryOTHER

McGill UniversityOTHER

Nova Scotia Health AuthorityOTHER

University of MichiganOTHER

Simon Fraser UniversityOTHER

University Health Network, TorontoOTHER

skhoshro@stjoes.ca905 522 1155 ext. 36462

khanr@providencecare.ca613-544-4900 ext. 53354

yamini.singh@theroyal.ca613.722.6521 ext. 6405

Marianne.Bautista@uhn.ca(416) 603-5800 ext. 6311

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