NCT05017311 Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)
| NCT ID | NCT05017311 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Nova Scotia Health Authority |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-01-20 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 400 participants in total. It began in 2023-01-20 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Rudolf Uher, MD
PRINCIPAL INVESTIGATOR
Nova Scotia Health Authority
Frequently Asked Questions
Who can join the NCT05017311 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05017311 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05017311 currently recruiting?
Yes, NCT05017311 is actively recruiting participants. Contact the research team at nicole.stinson@nshealth.ca for enrollment information.
Where is the NCT05017311 trial being conducted?
This trial is being conducted at Calgary, Canada, Vancouver, Canada, Halifax, Canada, Hamilton, Canada and 3 additional locations.
Who is sponsoring the NCT05017311 clinical trial?
NCT05017311 is sponsored by Nova Scotia Health Authority. The principal investigator is Rudolf Uher, MD at Nova Scotia Health Authority. The trial plans to enroll 400 participants.