Canadian Biomarker Integration Network for Depression Study

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborators: Centre for Addiction and Mental Health; McGill University; McMaster University; Queen's University; University of British Columbia; University of Calgary; University of Toronto
• Treatments: Aripiprazole; Citalopram; Dexetimide

Criteria

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.