Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D) (CAN-BIND-17)
Major Depressive Disorder
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring major depression, major depressive disorder, MDD, escitalopram, brexpiprazole, neuroimaging, genomics, proteomics, metabolomics
Eligibility Criteria
Patients
Inclusion Criteria:
- Outpatients 18 to 60 years of age.
- Meet DSM-5 criteria for MDE in MDD as determined by the MINI.
- Episode duration ≥ 3 months.
- 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.
- 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 60 years of age.
- No history of psychiatric disorders (as determined by the modified MINI v.6.0.) or significant physical conditions (e.g. arthritis, fibromyalgia).
- Fluency in English, sufficient to complete the interviews and self-report questionnaires.
Sites / Locations
- University of Calgary
- University of British Columbia
- Nova Scotia Health AuthorityRecruiting
- McMaster University
- Queen's University
- University Health Network
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Allocation by Predictive Biomarker Algorithm; Escitalopram + Brexpiprazole
Allocation by Predictive Biomarker Algorithm; Placebo
Random Allocation; Escitalopram + Brexpiprazole
Random Allocation; Placebo
Patients are randomly assigned to the Allocation by Predictive Biomarker Algorithm group. Based on the outcome result from the personalized predictive biomarker algorithm, patients predicted as non-responders to escitalopram monotherapy will receive open-label escitalopram (10-20 mg/d) and blinded brexpiprazole (0.5-2 mg/d) for the first 8 weeks of the study. For the final 4 weeks of the study, patients will continue to receive both medications but the brexpiprazole will no longer be blinded.
Patients are randomly assigned to the Allocation by Predictive Biomarker Algorithm group. Based on the outcome result from the personalized predictive biomarker algorithm, patients predicted to respond to escitalopram monotherapy will receive open-label escitalopram (10-20 mg/d) and blinded placebo for the first 8 weeks of the study. For the final 4 weeks of the study, responders will continue to receive open-label escitalopram without the placebo and non-responders will receive a combination of open-label escitalopram and open-label brexpiprazole.
Patients are randomly assigned to the Random Allocation group and then randomly assigned to receive open-label escitalopram (10-20 mg/d) and blinded brexpiprazole (0.5-2 mg/d) for the first 8 weeks of the study. For the final 4 weeks of the study, patients will continue to receive both medications but the brexpiprazole will no longer be blinded.
Patients are randomly assigned to the Random Allocation group and then randomly assigned to receive open-label escitalopram (10-20 mg/d) and blinded placebo for the first 8 weeks of the study. For the final 4 weeks of the study, responders will continue to receive open-label escitalopram without the placebo and non-responders will receive a combination of open-label escitalopram and open-label brexpiprazole.