Predicting treatment outcomes for major depression using a biomarker algorithm

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to test a predictive biomarker algorithm to determine the most effective medication treatment for patients experiencing a major depressive episode. It involves a multi-site, randomized approach with two treatment phases: an 8-week double-blind primary phase and a 4-week open-label extension phase. Participants will be assigned to either a Personalized Assignment group, where treatment is guided by the biomarker algorithm, or a Random Assignment group, where treatment is assigned randomly. The study will collect clinical, neurophysiological, and molecular data to enhance treatment personalization for major depressive disorder.

Why it matters

Who can join: the full rules

Patients

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Inclusion Criteria:

* 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 it's running

• University of Calgary
  Calgary, Alberta, Canada Recruiting
• University of British Columbia
  Vancouver, British Columbia, Canada Recruiting
• Nova Scotia Health Authority
  Halifax, Nova Scotia, Canada Recruiting
• McMaster University
  Hamilton, Ontario, Canada Recruiting
• Queen's University
  Kingston, Ontario, Canada Recruiting
• The Royal Ottawa Mental Health Centre
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Rudolf Uher, MD, PhD — Nova Scotia Health Authority
• Study coordinator: Jessica B Toombs, MSc
• Email: Jessica.Toombs@NSHealth.ca
• Phone: 9024735313

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.