Canadian Biomarker Integration Network for Depression (CAN-BIND) - Validation Study

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen by Sidney H Kennedy, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a validation study that will replicate a completed study designed to assess biomarkers of treatment response to standard antidepressant treatment. The goal of this study is to integrate clinical, imaging, EEG, and molecular data across 8 sites to predict treatment outcome for patients experiencing a major depressive episode (MDE).

Research Team

Sidney H Kennedy, MD

Principal Investigator

University Health Network, St. Michael's University, University of Toronto

Eligibility Criteria

Inclusion Criteria

Outpatients 18 to 60 years of age.

Meet DSM-5 criteria for MDE in MDD as determined by the MINI.

Episode duration > 3 months.

Treatment Details

Interventions

• Brexpiprazole (Atypical Antipsychotic)
• Escitalopram (Selective Serotonin Reuptake Inhibitor)

Participant Groups

Group I: brexpiprazole (0.5-2 mg) Active Control 1 Intervention

At week 8, participants classified as "non-responders" will be given 8 weeks of brexpiprazole as add-on treatment to escitalopram.

Group II: escitalopram (10-20 mg) Active Control 1 Intervention

Participants are given escitalopram for 8 weeks. At week 8, participants will be assessed and classified as "responders" or "non-responders". Responders will continue on escitalopram until the study endpoint (16 weeks).

Escitalopram is already approved in Canada for the following indications:

Approved in Canada as Cipralex for:

• Major depressive disorder
• Generalized anxiety disorder
• Social anxiety disorder

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Queen's University Kingston, Canada

University Health Network Toronto, Canada

University of British Columbia Vancouver, Canada

Centre for Addiction and Mental Health Toronto, Canada

More Trial Locations

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1555

Patients Recruited

526,000+

Kingston Health Sciences Centre

Collaborator

Trials

312

Patients Recruited

112,000+

University of Michigan

Collaborator

Trials

1891

Patients Recruited

6,458,000+

Baycrest

Collaborator

Trials

46

Patients Recruited

6,900+

University of Calgary

Collaborator

Trials

827

Patients Recruited

902,000+

McGill University

Collaborator

Trials

421

Patients Recruited

1,017,000+

Unity Health Toronto

Collaborator

Trials

572

Patients Recruited

470,000+

Centre for Addiction and Mental Health

Collaborator

Trials

388

Patients Recruited

84,200+

University of Ottawa

Collaborator

Trials

231

Patients Recruited

267,000+

Simon Fraser University

Collaborator

Trials

59

Patients Recruited

12,500+