Canadian Biomarker Integration Network for Depression Study

University Health Network, Toronto211 enrolled

Overview

This study is a pilot to assess feasibility of the protocol in patients and controls across six participating sites. The goal is to identify biological markers (biomarkers)that can be measured at baseline or early in treatment to predict treatment outcome in individual patients with Major Depressive Disorder (MDD). Biomarkers of interest will be clinical (using interview and self-report measures), molecular (from blood samples) and neurobiological (using neuroimaging and EEG).

This is a study to collect clinical and biomarker data which will be used to build models to predict treatment response. This is not a study to evaluate efficacy of medications, as medications in this study have been approved by Health Canada and are widely used for the treatment of MDD. This is an open label study involving MDD patients and healthy controls.Patients with a diagnosis of MDD and a current major depressive episode (MDE) will receive open-label standard of care treatment with escitalopram (10-20mg). Healthy controls will not receive medication; however, they will go through clinical assessments, blood collection and neuroimaging procedures. At week 8, patients will be assessed for medication response (response is defined as ≥ 50% reduction in MADRS scores from baseline). Responders will continue medication at their effective dose until study endpoint while non-responders will receive open label add-on treatment with aripiprazole (2-10mg). There are approximately 7 clinic visits over a 16 week period during which patients and healthy controls will undergo clinician administered scales and self reports, provide blood and urine samples (which will undergo proteomic and genomic analyses) as well as neuroimaging (fMRI and EEG). At the end of the study, mathematical modeling methods will be used to integrate the data from the various modalities to see which features best predict treatment outcome.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

211

Conditions

Major Depressive Disorder

Interventions

escitalopramDRUG

Patients will be given escitalopram for the first 8 weeks of the trial. At week 8, patients who are assessed as 'responders' will continue on escitalopram until study endpoint.

aripiprazoleDRUG

At Week 8, patients assessed as 'non-responders' will be given aripiprazole as an add-on treatment to escitalopram.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

For Depressed patients: Inclusion Criteria: * Outpatients who are 18-60 years of age * Meet DSM-IV-TR criteria for Major Depressive Episode in Major Depressive Disorder by the MINI * Episode duration ≥ 3 months * Free of psychotropic medications for at least 5 half-lives (i.e. 1 week for most antidepressants, 5 weeks for fluoxetine) before baseline Visit 1 * MADRS ≥ 24 * Fluency in English, sufficient to complete the interviews and self-report questionnaires Exclusion Criteria: * Any Axis I 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 3 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 and patients at risk for hypomanic switch (i.e. with a history of antidepressant hypomania) Inclusion criteria for Healthy Controls: * 18 to 60 years of age * No history of Axis I or Axis II disorders, as determined by the MINI. * Fluency in English, sufficient to complete the interviews and self-report questionnaires.

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 MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline

Clinical response (≥ 50% reduction in MADRS scores from baseline)

Time frame: Week 8, Week 16

Data from ClinicalTrials.gov

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