RecruitingPhase 4NCT05017311

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


Sponsor

Nova Scotia Health Authority

Enrollment

400 participants

Start Date

Jan 20, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining clinical information with brain imaging and biological markers can predict which antidepressant medication will work best for a specific patient. The goal is to reduce trial-and-error in depression treatment. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with a major depressive episode (MDD) confirmed by a structured interview - You are not currently taking any psychiatric medications (or have been off them for the required time period) - Your depression symptoms are significant (MADRS score of 24 or higher) - You are fluent in English and can complete questionnaires **You may NOT be eligible if...** - You are currently taking antidepressants or other psychiatric medications (except stable hypnotics or ADHD stimulants) - You have bipolar disorder, psychosis, or active substance use disorder - You have significant medical conditions that could affect brain or mood function - You are pregnant or breastfeeding - You have a history of non-response to multiple antidepressants Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEscitalopram

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

DRUGBrexpiprazole

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

View Full Details on ClinicalTrials.gov

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NCT05017311


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