Wellness Monitoring for Major Depressive Disorder (CBN-Well)

• ClinicalTrials.gov Identifier: NCT02934334
• Recruitment Status: Completed
• First Posted: October 14, 2016
• Last Update Posted: November 4, 2020
• Sponsor: Sidney Kennedy
• Information provided by (Responsible Party): Sidney Kennedy, University Health Network, Toronto

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Sidney H. Kennedy, MD; University Health Network, Toronto

More Information

Additional Information:

Press release 

CAN-BIND study website 

Publications:

Kennedy SH, Downar J, Evans KR, Feilotter H, Lam RW, MacQueen GM, Milev R, Parikh SV, Rotzinger S, Soares C. The Canadian Biomarker Integration Network in Depression (CAN-BIND): advances in response prediction. Curr Pharm Des. 2012;18(36):5976-89. doi: 10.2174/138161212803523635.

Lam RW, Milev R, Rotzinger S, Andreazza AC, Blier P, Brenner C, Daskalakis ZJ, Dharsee M, Downar J, Evans KR, Farzan F, Foster JA, Frey BN, Geraci J, Giacobbe P, Feilotter HE, Hall GB, Harkness KL, Hassel S, Ismail Z, Leri F, Liotti M, MacQueen GM, McAndrews MP, Minuzzi L, Muller DJ, Parikh SV, Placenza FM, Quilty LC, Ravindran AV, Salomons TV, Soares CN, Strother SC, Turecki G, Vaccarino AL, Vila-Rodriguez F, Kennedy SH; CAN-BIND Investigator Team. Discovering biomarkers for antidepressant response: protocol from the Canadian biomarker integration network in depression (CAN-BIND) and clinical characteristics of the first patient cohort. BMC Psychiatry. 2016 Apr 16;16:105. doi: 10.1186/s12888-016-0785-x.

Vaccarino AL, Evans KR, Kalali AH, Kennedy SH, Engelhardt N, Frey BN, Greist JH, Kobak KA, Lam RW, MacQueen G, Milev R, Placenza FM, Ravindran AV, Sheehan DV, Sills T, Williams JB. The Depression Inventory Development Workgroup: A Collaborative, Empirically Driven Initiative to Develop a New Assessment Tool for Major Depressive Disorder. Innov Clin Neurosci. 2016 Oct 1;13(9-10):20-31. eCollection 2016 Sep-Oct.

• 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
• 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:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms