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Wellness Monitoring for Major Depressive Disorder (CBN-Well)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02934334
Recruitment Status : Completed
First Posted : October 14, 2016
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Sidney Kennedy, University Health Network, Toronto

Brief Summary:
The Wellness Monitoring for Major Depressive Disorder (MDD) study is a prospective, longitudinal, observational study aimed at identifying biomarkers of relapse in MDD. Results may help refine clinical approach to relapse management, and may ultimately help MDD patients sustain wellness while on antidepressant medication.

Condition or disease Intervention/treatment
Major Depressive Disorder Other: Observational

Detailed Description:

This study involves a naturalistic follow up of responders from the study entitled "Integrated biological markers for the prediction of treatment response in depression", or the CAN-BIND-1 study. In addition, this study is also open to other participants who completed other CAN-BIND studies, as well as remitters who meet the inclusion criteria. Since patients usually seek medical attention only after relapse has occurred, imminent precursors to relapse are not well known. In this study, participants who are currently responding to an oral antidepressant treatment regimen and/or therapeutic intervention will be monitored over a minimum period of 13 months, which provides a unique opportunity to discover near-term biomarkers of relapse.

The study is conducted in partnership with Janssen Research & Development and utilizes remote monitoring technology for data gathering.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Collaborative Investigation of Predictors of Relapse in Major Depressive Disorder: CAN-BIND-1 Extension Study
Actual Study Start Date : May 31, 2016
Actual Primary Completion Date : January 14, 2019
Actual Study Completion Date : February 25, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MDD
Major Depressive Disorder
Other: Observational



Primary Outcome Measures :
  1. Rate of MDD Patients with Near Term Relapse [ Time Frame: Baseline up to the one year enrolment period for the last-subject-in. ]

    Relapse is defined as:

    1. MADRS total score equal to or greater than 22 on at least 2 consecutive visits (scheduled or unscheduled);
    2. Hospitalization for worsening of depression;
    3. Suicidal ideation with intent, or suicidal behaviour;
    4. Others. Investigators will be asked to describe.


Biospecimen Retention:   Samples With DNA

At each 8 week visit, blood samples for biochemical, genomic, and proteomic analysis will be collected and stored at -80'C freezer.

Plasma: Venous blood will be collected in 6mL and 10ml EDTA blood tubes, followed by centrifugation in a refrigerated centrifuge to obtain the plasma. Two milliliters of plasma from each tube will be divided into 8 cryovials (500µL).

DNA for methylation analysis: Venous blood will be collected in 8.5 mL PAXgene DNA tubes.

DNA for studying histone modifications: Venous blood will be collected in 6mL EDTA blood tubes and the mixed contents will be divided evenly into three 2 mL screw-cap tubes.

RNA for mRNA and miRNA sequencing: Venous blood will be collected in 6mL EDTA blood tubes and the mixed contents will be passed through LeukoLOCK filters according to the manufacturer's instructions.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men and women between 18 to 65 years of age who have previously met DSM-V criteria for Major Depressive Episode (MDE) in MDD as determined by MINI, (1) who participated in CAN-BIND-1 protocol, (2) other CAN-BIND studies, and (3) other remitters who meet the inclusion criteria who are currently responding to antidepressant medication or a combination of treatments.
Criteria

Inclusion Criteria:

  • Meet DSM-V criteria for Major Depressive Episode (MDE) in MDD as determined by MINI.
  • MADRS total score of equal to or less than 14.
  • In the current MDE, patient must currently be responding to an antidepressant medication or a combination of treatments for MDD.
  • Willing and able to complete self-reported assessments via a study-specific smartphone (LogPad), including sufficient fluency in English.
  • Willing to wear GT9X Link, a wrist-worn device for the duration of the study.

Exclusion Criteria:

  • Axis I diagnosis, other than MDD, that is considered the primary diagnosis.
  • Bipolar I or Bipolar II diagnosis (lifetime), MDD with psychotic features (lifetime), schizophrenia, or schizoaffective disorder.
  • Presence of a significant Axis II diagnosis (borderline, antisocial).
  • High suicidal risk, defined by clinician judgement.
  • History of drug or alcohol use, with severity of at least moderate or severe, according to DSM criteria, within 6 months before screening.
  • Presence of significant neurological disorders, head trauma, or other unstable medical conditions.
  • Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before screening or is currently enrolled in an investigational study.
  • Has a condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g. compromise well being) or that could prevent, limit, or confound the protocol-specified assessments.
  • Subject is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of an employee or the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934334


Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z3
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3K7
Queen's University
Kingston, Ontario, Canada, K7L 4X3
University Health Network
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
Sidney Kennedy
Investigators
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Principal Investigator: Sidney H. Kennedy, MD University Health Network, Toronto
Additional Information:
Publications:
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Responsible Party: Sidney Kennedy, Senior Scientist, Psychiatrist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02934334    
Other Study ID Numbers: REB 15-9780-AE
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: This study is funded in part by the Ontario Brain Institute (OBI). Data collected from this study is entered into a research database called "Brain-CODE", deployed at a High Performance Computer Virtual Lab (HPCVL). The HPCVL supports the regulatory-compliant (e.g., 21 CRF Part 11, HIPAA, PIPEDA) processes for securing privacy of healthcare data.
Keywords provided by Sidney Kennedy, University Health Network, Toronto:
major depression
major depressive episode
biomarkers
relapse
near term relapse
m-health
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms