Canadian Biomarker Integration Network for Depression (CAN-BIND) - Validation Study

University Health Network, Toronto1 enrolled

Overview

This is a validation study that will replicate a completed study designed to assess biomarkers of treatment response to standard antidepressant treatment. 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).

This is a multi-site study to replicate a previous multi-site, multi-platform study completed by the Canadian Biomarker Integration Network in Depression (CAN-BIND). This study aims to validate the integrated array of markers of response and non-response to first line antidepressant treatments that were previously identified in the original aforementioned study. This will be accomplished through collection of clinical, neurophysiological, and molecular measures. This is not a study to evaluate efficacy of medications; medications in this study have been approved by Health Canada and are widely used for the treatment of MDD. In this study, individuals diagnosed with MDD in a current major depressive episode (MDE) will be treated with open-label escitalopram for 8 weeks. At week 8, participants will be assessed for treatment response (defined as a ≥50% reduction in Montgomery Asberg Depression Rating Scale score). Responders will continue on escitalopram for 8 more weeks. Non-responders will be given add-on brexpiprazole treatment, in addition to escitalopram, for 8 weeks. Over the 16 weeks, pariticipants will attend 7 clinical visits where they will complete clinical assessments (clinician administered and self-report) and cognitive tests; provide blood, urine, and stool samples; undergo neuroimaging procedures (MRI and EEG); and provide speech samples. At the end of the study, modeling methods will be used to integrate data from these measures to determine the features that best predict treatment outcome.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Major Depressive Disorder

Interventions

EscitalopramDRUG

Participants are given escitalopram for 8 weeks. At week 8, those classified as responders will continue on escitalopram until the end of study.

BrexpiprazoleDRUG

Participants who are classified as non-responders are given 8 weeks add-on brexpiprazole, in addition to escitalopram, for the remainder of the study.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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).

Locations (6)

University of Calgary

Calgary, Alberta, Canada

University of British Columbia

Vancouver, British Columbia, Canada

McMaster University

Hamilton, Ontario, Canada

Queen's University

Kingston, Ontario, Canada

Outcomes

Primary Outcomes

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 and Week 16 visits, by 50% or greater, from MADRS score at Baseline visit (i.e., lower MADRS scores = better outcome)

Time frame: Week 8, Week 16

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.