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

Last updated: March 12, 2024
Sponsor: Nova Scotia Health Authority
Overall Status: Active - Recruiting

Phase

4

Condition

Depression

Depression (Major/severe)

Depression (Adult And Geriatric)

Treatment

Escitalopram

Brexpiprazole

Clinical Study ID

NCT05017311
1027397
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

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 mostantidepressants, 5 weeks for fluoxetine) before baseline Visit 1 (exceptions: stableuse of hypnotics; stable use of stimulants for attention-deficit/hyperactivedisorder).
  • 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). Healthy Comparison (HC) Participants Inclusion Criteria:
  • 18 to 65 years of age.
  • No history of psychiatric disorders (as determined by SCID-5) or significant physicalconditions (e.g. arthritis, fibromyalgia).
  • Fluency in English, sufficient to complete the interviews and self-reportquestionnaires.

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Escitalopram
Phase: 4
Study Start date:
January 20, 2023
Estimated Completion Date:
April 30, 2029

Study Description

This is a multi-site, randomized study with two treatment phases: a double-blind primary treatment phase of 8 weeks, and an open-label secondary extension phase of 4 weeks. This study aims to test a predictive biomarker algorithm to select medication treatment for patients with major depressive disorder (MDD) based on results from the recently completed Canadian Biomarker Integration Network in Depression (CAN-BIND)-1 study. This will be accomplished through collection of clinical, neurophysiological, and molecular measures from both MDD patients and healthy controls. 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 randomly assigned to one of the two treatment groups: Personalized Assignment group or Random Assignment group. Patients in the Random Assignment group will randomly receive open-label escitalopram with the addition of either blinded placebo or brexpiprazole for 8 weeks. Patients in the Personalized Assignment group will receive open-label escitalopram with the addition of either placebo or blinded brexpiprazole for 8 weeks depending on what the predictive biomarker algorithm suggests.

At Week 8, participants will be assessed for treatment response (defined as a ≥50% reduction in Montgomery Asberg Depression Rating Scale score). All patients who initially received both open-label escitalopram and blinded brexpiprazole (regardless of treatment group) will continue to receive these medications for another 4 weeks but the brexpiprazole will no longer be blinded. For those patients who initially received open-label escitalopram and blinded placebo (regardless of treatment group), nonresponders will receive open-label escitalopram and open-label brexpiprazole for another 4 weeks and responders will receive open-label escitalopram only for another 4 weeks.

Over the 12 weeks, participants will attend 7 study 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

  • Nova Scotia Health Authority

    Halifax, Nova Scotia B3H 2E2
    Canada

    Active - Recruiting

  • 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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