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NCT Number: NCT06408012

An Innovative Master 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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Inclusion criteria

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.

Treatment and study plan

Primary outcomes

  1. Rate of participation in the master trial platform

    Time frame: 31st March 2026

    Number of participants who consent to be included in the registry

Study contacts

Contact information is provided by the study sponsor or research team.

Saba Khoshroo

CONTACT

[email protected]

905-522-1155 ext. 36462

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ENABLE

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
May 9, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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