Predicting treatment outcomes for major depression using a biomarker algorithm
Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)
This study is testing a new way to use a biomarker to see if it can help doctors choose the best medication for people with major depression.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 7 sites (Calgary, Alberta and 6 other locations) |
| Trial ID | NCT05017311 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are outpatients aged 18 to 65 who meet the criteria for a major depressive episode and have a MADRS score of 24 or higher.
Not a fit: Patients with diagnoses other than major depressive disorder, high suicidal risk, or significant neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with major depressive disorder.
How similar studies have performed: Other studies have shown promise in using predictive algorithms for treatment personalization in depression, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Calgary, Alberta and 6 other locations
- University of Calgary — Calgary, Alberta, Canada (Not_yet_recruiting)
- University of British Columbia — Vancouver, British Columbia, Canada (Not_yet_recruiting)
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Recruiting)
- McMaster University — Hamilton, Ontario, Canada (Not_yet_recruiting)
- Queen's University — Kingston, Ontario, Canada (Not_yet_recruiting)
- University Health Network — Toronto, Ontario, Canada (Not_yet_recruiting)
- Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Rudolf Uher, MD — Nova Scotia Health Authority
- Study coordinator: Nicole Stinson, BSc
- Email: nicole.stinson@nshealth.ca
- Phone: 9024735313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.