Canadian Biomarker Integration Network for Depression (CAN-BIND)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-23

Study Completion Date

2022-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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escitalopram (10-20 mg)

Participants are given escitalopram for 8 weeks. At week 8, participants will be assessed and classified as "responders" or "non-responders". Responders will continue on escitalopram until the study endpoint (16 weeks).

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

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

brexpiprazole (0.5-2 mg)

At week 8, participants classified as "non-responders" will be given 8 weeks of brexpiprazole as add-on treatment to escitalopram.

Group Type ACTIVE_COMPARATOR

Brexpiprazole

Intervention Type DRUG

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

Interventions

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Escitalopram

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

Intervention Type DRUG

Brexpiprazole

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

Intervention Type DRUG

Other Intervention Names

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Cipralex Rexulti

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Sidney Kennedy

Professor of Psychiatry, University of Toronto, Arthur Sommer Rotenberg Chair in Suicide & Depression Studies, St. Michael's Hospital, Principal Investigator, Canadian Biomarker Integration Network for Depression, University Health Network

Responsibility Role PRINCIPAL_INVESTIGATOR