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RECRUITING
NCT05017311
PHASE4

Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)

Sponsor: Nova Scotia Health Authority

View on ClinicalTrials.gov

Summary

This is a study that will test a predictive biomarker algorithm based on results from a previous study. 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).

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2023-01-20

Completion Date

2029-04-30

Last Updated

2026-02-27

Healthy Volunteers

Yes

Interventions

DRUG

Escitalopram

All patients will receive open-label escitalopram (10-20 mg/d) for the entire study duration (12 weeks).

DRUG

Brexpiprazole

Depending on the initial randomization process, patients will either receive blinded brexpiprazole (0.5-2 mg/d) for the entire study duration (12 weeks) or for the last 4 weeks of the study if they received the placebo during the first 8 weeks of the study and were non-responders.

Locations (7)

University of Calgary

Calgary, Alberta, Canada

University of British Columbia

Vancouver, British Columbia, Canada

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

McMaster University

Hamilton, Ontario, Canada

Queen's University

Kingston, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Centre for Addiction and Mental Health

Toronto, Ontario, Canada