An Innovative Master Platform for Clinical Trials in Mood Disorders

NCT06408012 | Recruiting

• 1 other identifier: CAN-BIND-18
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 9

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.

Conditions

Depressive Disorder; Bipolar and Related Disorders; Mood Disorders

Outcome Measures

Primary Outcomes (1)

• Rate of participation in the master trial platform

  Number of participants who consent to be included in the registry

  31st March 2026

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who meet criteria for bipolar or depressive disorders as defined by DSM-5.

You may qualify if:

• Patients:
• 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.
• Healthy Comparison (HC) Participants:
• 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.

Sponsors & Collaborators

• Unity Health Toronto: collaborator
• Centre for Addiction and Mental Health: collaborator
• Queen's University: collaborator
• University of Ottawa: collaborator
• University of British Columbia: collaborator
• University of Calgary: collaborator
• McGill University: collaborator
• Nova Scotia Health Authority: collaborator
• University of Michigan: collaborator
• Simon Fraser University: collaborator
• St. Joseph's Healthcare Hamilton: lead
• University Health Network, Toronto: collaborator

Study Sites (9)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

University of British Columbia

Vancouver, British Columbia, V6T 2A1, Canada

RECRUITING

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2E2, Canada

RECRUITING

McMaster University

Hamilton, Ontario, L8P 3B6, Canada

RECRUITING

Queen's University

Kingston, Ontario, K7L4X3, Canada

RECRUITING

University of Ottawa

Ottawa, Ontario, K1Z 7K4, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

Ontario Shores Centre for Mental Health Sciences

Whitby, Ontario, L1N 5S9, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood Plasma: Venous blood will be collected in blood collection tubes, followed by centrifugation in a refrigerated centrifuge to obtain the plasma. The entire plasma sample from each tube will be equally divided into labelled cryovials (each minimum 1 mL) and stored at -80oC at the clinical site. Peripheral Blood Mononuclear Cells (PBMCs): Venous blood will be collected in blood collection tubes, followed by centrifugation and processing to obtain PBMCs that will be divided in 1 ml labeled aliquots and stored at -80oC at the clinical site. Whole blood for RNA analysis: Venous blood will be collected in blood collection tubes, processed following the most updated SOP, labeled, and stored at -80oC at each clinical site.

MeSH Terms

Conditions

Mood Disorders; Depressive Disorder; Bipolar and Related Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Benicio N Frey

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saba Khoshroo

CONTACT

905-522-1155; skhoshro@stjoes.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry and Behavioural Neurosciences

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: October 17, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Currently till the end of March, 2026.
• Access Criteria: By application.

Locations

CA (9)