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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Health Network, Toronto
Sponsor:
Collaborators:
University of Toronto
University of Calgary
University of British Columbia
McGill University
Queen's University
Centre for Addiction and Mental Health
McMaster University
Information provided by (Responsible Party):
Sidney Kennedy, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01655706
First received: July 27, 2012
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention Phase
Major Depressive Disorder
Drug: escitalopram
Drug: aripiprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Integrated Biological Markers for the Prediction of Treatment Response in Depression: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline [ Time Frame: Week 8, Week 16 ] [ Designated as safety issue: No ]
    Clinical response (≥ 50% reduction in MADRS scores from baseline)


Estimated Enrollment: 132
Study Start Date: March 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: escitalopram (10-20mg)
Patients are on escitalopram for 8 weeks. At Week 8, patients will be assessed as 'responders' or 'non-responders'. 'Responders' will continue on escitalopram until study endpoint.
Drug: escitalopram
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.
Other Name: Cipralex
Active Comparator: aripiprazole (2-10mg)
At Week 8, patients assessed as 'non-responders' will be given aripiprazole as an add-on treatment to escitalopram.
Drug: escitalopram
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.
Other Name: Cipralex
Drug: aripiprazole
At Week 8, patients assessed as 'non-responders' will be given aripiprazole as an add-on treatment to escitalopram.
Other Name: Abilify

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

For Depressed patients:

Inclusion Criteria:

  • Outpatients who are 18-55 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 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 55 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655706

Contacts
Contact: Sidney Kennedy, MD 416-340-4800 ext 3888
Contact: Susan Rotzinger, PhD 416-340-4800 ext 6040

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Natalia Jaworska    403-210-7321    jaworskn@ucalgary.ca   
Principal Investigator: Glenda MacQueen, MD, PhD         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6T 2A1
Contact: Cindy Woo    604-822-7627    cindy.woo@ubc.ca   
Principal Investigator: Raymond Lam, MD         
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8P 3B6
Contact: Tracy Woodford    905-522-1155 ext 32048    twoodfor@stjoes.ca   
Principal Investigator: Benicio Frey, MD, PhD         
Queen's University Recruiting
Kingston, Ontario, Canada, K7L 4X3
Contact: Kathleen Walker    613-548-5567 ext 6123    walkerk1@providencecare.ca   
Principal Investigator: Roumen Milev, MD, PhD         
University Health Network Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Hannah Woldeyohannes    416-603-5800 ext 5133    hannah.woldeyohannes@uhn.ca   
Principal Investigator: Roger McIntyre, MD         
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5T 1R8
Contact: Jonathan Ramirez    416-535-8501 ext 39273    jonathan.ramirez@camh.ca   
Principal Investigator: Arun Ravindran, MD         
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Franca Placenza    416-340-4800 ext 8839    franca.placenza@uhn.ca   
Principal Investigator: Sidney Kennedy, MD         
Sponsors and Collaborators
University Health Network, Toronto
University of Toronto
University of Calgary
University of British Columbia
McGill University
Queen's University
Centre for Addiction and Mental Health
McMaster University
Investigators
Principal Investigator: Sidney Kennedy, MD University Health Network, University of Toronto
  More Information

Additional Information:
Publications:
Responsible Party: Sidney Kennedy, Psychiatrist-in-Chief, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01655706     History of Changes
Other Study ID Numbers: 09-0117-A
Study First Received: July 27, 2012
Last Updated: November 26, 2013
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
major depression
major depressive disorder
biomarkers
escitalopram
aripiprazole
MDD
neuroimaging
proteomic
genomics

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Aripiprazole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents

ClinicalTrials.gov processed this record on August 28, 2014