An Innovative Master Platform for Clinical Trials in Mood Disorders

Last updated: January 7, 2025
Sponsor: St. Joseph's Healthcare Hamilton
Overall Status: Active - Recruiting

Phase

N/A

Condition

Affective Disorders

Autism

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT06408012
CAN-BIND-18
  • Ages > 16
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 900
Study Start date:
October 17, 2023
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • University of Calgary

    Calgary, Alberta T2N 4Z6
    Canada

    Active - Recruiting

  • University of British Columbia

    Vancouver, British Columbia V6T 2A1
    Canada

    Active - Recruiting

  • Nova Scotia Health Authority

    Halifax, Nova Scotia B3H 2E2
    Canada

    Active - Recruiting

  • McMaster University

    Hamilton, Ontario L8P 3B6
    Canada

    Active - Recruiting

  • Queen's University

    Kingston, Ontario K7L4X3
    Canada

    Site Not Available

  • University of Ottawa

    Ottawa, Ontario K1Z 7K4
    Canada

    Site Not Available

  • Centre for Addiction and Mental Health

    Toronto, Ontario M6J 1H4
    Canada

    Active - Recruiting

  • University Health Network

    Toronto, Ontario M5T 2S8
    Canada

    Active - Recruiting

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