Clinical trial NCT06408012: An Innovative Master Platform for Clinical Trials in Mood Disorders
Official title: Enabling Neuroscience Research Approaches for Brain, FeeLings and Emotions (ENABLE): an Innovative Platform for Clinical Trials in Mood Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mood Disorders
Depressive Disorder
Bipolar and Related Disorders
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
name: Centre for Addiction and Mental Health
name: Queen's University
name: University of Ottawa
name: University of British Columbia
name: University of Calgary
name: McGill University
name: Nova Scotia Health Authority
name: University of Michigan
name: Simon Fraser University
name: University Health Network, Toronto
First posted: 2024-05-09
Enrollment: 900
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who meet criteria for bipolar or depressive disorders as defined by DSM-5.

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 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.

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.

Primary outcomes:
measure: Rate of participation in the master trial platform
timeFrame: 31st March 2026
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Benicio N Frey
role: PRINCIPAL_INVESTIGATOR
References: