Actively Recruiting
Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)
Led by Nova Scotia Health Authority · Updated on 2026-02-27
400
Participants Needed
7
Research Sites
327 weeks
Total Duration
On this page
Sponsors
N
Nova Scotia Health Authority
Lead Sponsor
U
Unity Health Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients 18 to 65 years of age
- Meet DSM-5 criteria for major depressive episode (MDE) in major depressive disorder (MDD) as determined by SCID-5
- Free of psychotropic medications for at least 5 half-lives before baseline visit (exceptions: stable use of hypnotics or stimulants for ADHD)
- Montgomery Asberg Depression Rating Scale (MADRS) score of 24 or higher
- Fluency in English sufficient to complete interviews and self-report questionnaires
- Healthy controls aged 18 to 65 years with no history of psychiatric disorders or significant physical conditions
- Fluency in English sufficient to complete interviews and self-report questionnaires (healthy controls)
You will not qualify if you...
- Any primary diagnosis other than major depressive disorder (MDD)
- Bipolar I or Bipolar II diagnosis
- Significant Axis II diagnosis such as borderline or antisocial personality disorder
- High suicidal risk as judged by a clinician
- Substance dependence or abuse within the past 6 months
- Significant neurological disorders, head trauma, or other unstable medical conditions
- Pregnant or breastfeeding
- Failure of 4 or more adequate pharmacologic treatments
- Started psychological treatment within the past 3 months intending to continue treatment
- Previous failure or intolerance to escitalopram or brexpiprazole
- Risk for hypomanic switch, including history of antidepressant-induced hypomania
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Not Yet Recruiting
2
University of British Columbia
Vancouver, British Columbia, Canada, V6T2A1
Not Yet Recruiting
3
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 2E2
Actively Recruiting
4
McMaster University
Hamilton, Ontario, Canada, L8P3B6
Not Yet Recruiting
5
Queen's University
Kingston, Ontario, Canada, K7L4X3
Not Yet Recruiting
6
University Health Network
Toronto, Ontario, Canada, M5T2S8
Not Yet Recruiting
7
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J1H4
Not Yet Recruiting
Research Team
N
Nicole Stinson, BSc
CONTACT
J
Jill M Cumby, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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