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

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).

Conditions

• Major Depressive Disorder

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.

Sponsors & Collaborators

• Unity Health Toronto

  collaborator OTHER

• Centre for Addiction and Mental Health

  collaborator OTHER

• McMaster University

  collaborator OTHER

• Queen's University

  collaborator OTHER

• University of Ottawa

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• McGill University

  collaborator OTHER

• Dalhousie University

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Simon Fraser University

  collaborator OTHER

• Nova Scotia Health Authority

  lead OTHER

Principal Investigators

• Rudolf Uher, MD · Nova Scotia Health Authority

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-01-20

Primary Completion

2028-12-31

Completion

2029-04-30

Countries

• Canada

Study Locations