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

Last updated: February 28, 2023
Sponsor: University Health Network, Toronto
Overall Status: Completed

Phase

3

Condition

Depression

Mood Disorders

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT04162522
19-5371
  • Ages 18-60
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 mostantidepressants, 5 weeks for fluoxetine) before baseline Visit 1.
  • MADRS score ≥ 24.
  • Fluency in English, sufficient to complete the interviews and self-reportquestionnaires.

Exclusion

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 medicalconditions.
  • Pregnant or breastfeeding.
  • Failure of 4 or more adequate pharmacologic interventions (as determined by theAntidepressant Treatment History Form).
  • Started psychological treatment within the past 3 months with the intent of continuingtreatment.
  • Patients who have previously failed escitalopram or showed intolerance to escitalopramor brexpiprazole, and patients at risk for hypomanic switch (i.e. with a history ofantidepressant induced hypomania).

Study Design

Total Participants: 1
Study Start date:
December 23, 2019
Estimated Completion Date:
December 31, 2022

Study Description

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.

Connect with a study center

  • University of Calgary

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • University of British Columbia

    Vancouver, British Columbia V6T2A1
    Canada

    Site Not Available

  • McMaster University

    Hamilton, Ontario L8P3B6
    Canada

    Site Not Available

  • Queen's University

    Kingston, Ontario K7L4X3
    Canada

    Site Not Available

  • Centre for Addiction and Mental Health

    Toronto, Ontario M6J1H4
    Canada

    Site Not Available

  • University Health Network

    Toronto, Ontario M5T2S8
    Canada

    Site Not Available

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