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

What this study 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).

Who can join (things the study team will check)

✅ You may be able to join if…

• Outpatients 18 to 65 years of age.
• Meet DSM-5 criteria for MDE in MDD as determined by SCID-5.
• Free of psychotropic medications for at least 5 half-lives (e.g. 1 week for most antidepressants, 5 weeks for fluoxetine) before baseline Visit 1 (exceptions: stable use of hypnotics; stable use of stimulants for attention-deficit/hyperactive disorder).
• MADRS score ≥ 24.
• Fluency in English, sufficient to complete the interviews and self-report questionnaires.

🚫 You may not be able to join if…

• Any diagnosis, other than MDD, that is considered the primary diagnosis.
• Bipolar I or Bipolar-II diagnosis.
• Presence of a significant Axis II diagnosis (borderline, antisocial).
• High suicidal risk, defined by clinician judgment.
• Substance dependence/abuse in the past 6 months.
• Presence of significant neurological disorders, head trauma, or other unstable medical conditions.
• Pregnant or breastfeeding.
• Failure of 4 or more adequate pharmacologic interventions (as determined by the Antidepressant Treatment History Form).
• Started psychological treatment within the past 3 months with the intent of continuing treatment.
• Patients who have previously failed escitalopram or showed intolerance to escitalopram or brexpiprazole, and patients at risk for hypomanic switch (i.e. with a history of antidepressant induced hypomania). Healthy Comparison (HC) Participants

✅ You may be able to join if…

• 18 to 65 years of age.
• No history of psychiatric disorders (as determined by SCID-5) or significant physical conditions (e.g. arthritis, fibromyalgia).
• Fluency in English, sufficient to complete the interviews and self-report questionnaires.

Where this trial is running

• 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
• The Royal Ottawa Mental Health Centre, Ottawa, Ontario, Canada
• University Health Network, Toronto, Ontario, Canada
• Centre for Addiction and Mental Health, Toronto, Ontario, Canada
• Ontario Shores Centre for Mental Health Sciences, Whitby, Ontario, Canada
• University of Saskatchewan, Saskatoon, Saskatchewan, Canada

Who to contact

Jessica B Toombs, MSc · 9024735313 · Jessica.Toombs@NSHealth.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05017311.