An Innovative Master Platform for Clinical Trials in Mood Disorders

Depressive Disorder Clinical Trial

— ENABLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06408012
• Other study ID #: CAN-BIND-18
• Status: Recruiting
• Start date: October 17, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2024
• Source: St. Joseph's Healthcare Hamilton
• Contact: Saba Khoshroo
• Phone: 905-522-1155
• Email: skhoshro[@]stjoes.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar and Related Disorders
• Depressive Disorder
• Mood Disorders

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	McMaster University	Hamilton	Ontario
Canada	Queen's University	Kingston	Ontario
Canada	University of Ottawa	Ottawa	Ontario
Canada	Centre for Addiction and Mental Health	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (12)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of participation in the master trial platform	Number of participants who consent to be included in the registry	31st March 2026