RecruitingPhase 4

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

Canada400 participantsStarted 2023-01-20

Plain-language 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).

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 deter…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing whether a predictive or optimized approach to choosing antidepressants works better for major depression — can you explain what 'optimized predictive treatment' actually means in practice, and how it differs from how you would normally adjust my medication?
2Since this is a Phase 4 trial, the medications being used are already FDA-approved, but is there anything still unknown about how this particular treatment-selection strategy affects safety or outcomes that I should weigh before deciding whether to participate?
3The trial measures changes in depression symptoms using a scale called the MADRS — how often would I be assessed during the study, and what would those check-ins involve in terms of time and visits?
4Could taking part in this trial delay or interfere with starting a standard antidepressant treatment that you might otherwise recommend for me right now?
5Given that this trial is still actively recruiting, what is the realistic timeline for my involvement, and if the assigned treatment approach isn't working well for me, what options would I have to change course?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline

Timeframe: Baseline to Week 8

Trial details

NCT IDNCT05017311

SponsorNova Scotia Health Authority

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Jessica B Toombs, MSc

9024735313 Jessica.Toombs@NSHealth.ca

View on ClinicalTrials.gov More Major Depressive Disorder trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.