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).
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.
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.
Factorial
Escitalopram
DrugAll patients will receive open-label escitalopram (10-20 mg/d) for the entire study duration (12 weeks).
Brexpiprazole
DrugDepending on the initial randomization process, patients will either receive blinded brexpiprazole (0.5-2 mg/d) for the entire study duration (12 weeks) or for the last 4 weeks of the study if they received the placebo during the first 8 weeks of the study and were non-responders.
Change in Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline
Measured as clinical response, defined as a decrease in Montgomery Asberg Depression Rating Scale (MADRS) score at the Week 8 visit, by 50% or greater, from MADRS score at Baseline visit (i.e., lower MADRS scores = better outcome)
Clinical response
Defined as a decrease in MADRS score at the Week 8 visit, by 50% or greater, from MADRS score at Baseline visit
Time to clinical response
Defined as time (i.e., number of weeks) to achieve clinical response (i.e., decrease in MADRS score at the Week 8 visit, by 50% or greater, from MADRS score at Baseline visit)
Remission at Week 8
Defined as MADRS score ≤10 at Week 8
Week 12 clinical outcome - Response
Response at Week 12 - defined as a decrease in MADRS score at the Week 12 visit, by 50% or greater, from MADRS score at Baseline visit and Week 8
Week 12 clinical outcome - Remission
Defined as MADRS score ≤10 at Week 12
Click on the lead sponsor to view all of their trials.
Nova Scotia Health Authority
Lead sponsor
Unity Health Toronto
Collaborator
Centre for Addiction and Mental Health
Collaborator
McMaster University
Collaborator
Queen's University
Collaborator
University of Ottawa
Collaborator
University of British Columbia
Collaborator
University of Calgary
Collaborator
McGill University
Collaborator
Dalhousie University
Collaborator
University of Michigan
Collaborator
Simon Fraser University
Collaborator
Ontario Shores Centre for Mental Health Sciences
Collaborator
University of Saskatchewan
Collaborator
