Wellness Monitoring for Major Depressive Disorder (CBN-Well)

November 3, 2020 updated by: Sidney Kennedy

A Collaborative Investigation of Predictors of Relapse in Major Depressive Disorder: CAN-BIND-1 Extension Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • University of British Columbia
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3K7
        • McMaster University
      • Kingston, Ontario, Canada, K7L 4X3
        • Queen's University
      • Toronto, Ontario, Canada, M5T 2S8
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline up to the one year enrolment period for the last-subject-in.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kennedy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2016

Primary Completion (Actual)

January 14, 2019

Study Completion (Actual)

February 25, 2019

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB 15-9780-AE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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